Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467643
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-14
Brief Title:
Minimally Invasive Root Canal Treatment With Active Disinfection on Single Rooted Teeth With Periapical Lesions
Sponsor:
Saint-Joseph University
Organization:
Saint-Joseph University
Study Overview
Official Title:
Minimally Invasive Root Canal Treatment With Active Disinfection on Single Rooted Teeth With Periapical Lesions A Preliminary Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A novel form of root canal treatment RCT referred as minimally invasive endodontics MIE has emerged recently to adopt a unique approach that emphasize reducing tooth structural changes post-treatment 32 MIE seeks to maintain as much of the tooths healthy coronal cervical and radicular anatomy as practical Access opening root canal cleaning and shaping as well as surgical endodontics are all potential areas where MIE can be applied in endodontic therapy 3436 Technological and technical progress based on new tools files and devices are now allowing the simplification of this approach
In the context of endodontics the question may be whether conventional therapeutic approaches are minimally invasive enough 3234 or whether a less invasive approach is required This preliminary clinical study examined radiographically a minimally invasive shaping protocol combined with heated multi-sonic based irrigation to achieve disinfection with the removal of the least amount of dentin from the roots hard tissue during root canal shaping compared to conventionally instrumented root canals by focusing on the following aspects
The change in the area of the periapical lesion measured in square millimeters between T0 T3 T6 and T9
The speed of repair of healedhealing periapical lesions absolute speed of shrinkage and relative speed of shrinkage
In addition this study evaluated the association between radiographic outcomes and the type of endodontic treatment Results obtained concerning the mentioned factors were compared across both techniques as well as the available ex-vivo and in vivo studies present in the literature With the objective of cleaning and disinfecting the root canals as a complex while conserving root integrity further efforts to adopt such technique in posterior teeth where the mastication force and stress are at their most could be done to set guidelines for an effective and more conservative root canal therapy
In the context of endodontics the question may be whether conventional therapeutic approaches are minimally invasive enough 3234 or whether a less invasive approach is required This preliminary clinical study examined radiographically a minimally invasive shaping protocol combined with heated multi-sonic based irrigation to achieve disinfection with the removal of the least amount of dentin from the roots hard tissue during root canal shaping compared to conventionally instrumented root canals by focusing on the following aspects
The change in the area of the periapical lesion measured in square millimeters between T0 T3 T6 and T9
The speed of repair of healedhealing periapical lesions absolute speed of shrinkage and relative speed of shrinkage
In addition this study evaluated the association between radiographic outcomes and the type of endodontic treatment Results obtained concerning the mentioned factors were compared across both techniques as well as the available ex-vivo and in vivo studies present in the literature With the objective of cleaning and disinfecting the root canals as a complex while conserving root integrity further efforts to adopt such technique in posterior teeth where the mastication force and stress are at their most could be done to set guidelines for an effective and more conservative root canal therapy
Detailed Description:
Microorganisms are the primary cause of pulp and periapical disorders 1 The key objective of endodontic therapy is to prevent or to heal apical periodontitis by eliminating inflamed andor infected pulpal tissues and establishing aseptic intraradicular conditions conductive to periradicular healing 2 This goal is achieved by performing a chemo-mechanical debridement of the root canal system all while preserving the tooths structural integrity for successful function 34
Root canal instrumentation is primarily done to optimize irrigation and cleaning particularly in the apical region and to facilitate an hermetic obturation 56 However mechanical instrumentation is linked with multiple drawbacks including the production of dentin debris and smear layer the occurrence of iatrogenic errors root structure weakening and apical crack formation 7 It was also demonstrated that endodontic files are unable to touch the whole surface of the root canal walls due to the complexity of the root canal anatomy affecting the total cleaning and the final prognosis 8 Accordingly a variety of techniques and instruments can be used to render this step minimally invasive 9 as well as to improve the penetration of irrigants into the anatomical complexities 1011 Minimally invasive endodontics MIE involves minimum intervention using smaller size and taper rotating files in combination with more effective irrigation protocols 12
Ultrasonic activation of intracanal heated sodium hypochlorite NaOCl as a final irrigation protocol following root canal preparation showed superior bacterial reduction compared to canal preparation and NaOCl activation alone 13 Acoustic streaming and cavitation of heated irrigant are thought to be the working mechanisms 1415 Recent in vitro studies have argued whether such irrigation protocols could be suitable to disinfect non-instrumented and or minimally tapered root canals 61316
Until now no randomized clinical trials RCTs evaluated the in vivo efficacy of this protocol in un-instrumented canals In the absence of sufficient models for clinical outcomes only direct clinical studies evaluating both apical bone fill and tooth functionsurvival will offer compelling evidence regarding the efficacy of canal disinfection 4 Therefore the aim of this preliminary randomized clinical trial was to evaluate radiographically the healing of periapical lesions on single rooted teeth following a non-instrumentation technique using ultrasonic activation with intracanal heating of sodium hypochlorite IHAN compared to rotary canal instrumentation and ultrasonic activation with heating of NaOCl R-IHAN
- Sample size To determine the sample size a power analysis for repeated-measures ANOVA within-subjects factor with 4 measurements was conducted using GPower software 3197 for Windows Heinrich Heine Universitat Düsseldorf Düsseldorf Germany a power of 08 an alpha level of 005 were considered and an effect size of 035 was calculated based on a previous study conducted by van der Borden et al 34 The minimum sample size required is 13 periapical lesions per group 26 in total In order to account for losses to follow-up an attrition rate of 20 was added which results in a minimum total sample size of 32 16 per group
Patient Selection Based on a power analysis for repeated-measures ANOVA within-subjects factor with 4 measurements the minimum sample size required is 13 periapical lesions per group 26 in total In order to account for losses to follow-up an attrition rate of 20 was added which results in a minimum total sample size of 32 16 per group Patients with a noncontributory medical history were recruited at the Postgraduate Endodontics Clinic of the Faculty of Dentistry at the Saint Joseph University Beirut-Lebanon and were asked to sign a printed informed consent form after a detailed explanation of treatment procedures possible outcomes complications and follow-up period desired All selected teeth were single rooted maxillary and mandibular incisors canines or premolars with negative response on sensitivity testing and radiographic evidence of periapical bone loss of periapical index score PAI 3 according to the classification of Ørstavik et al 1986 Only root canals in which stainless steel Kfile size 15 Maillefer Ballaigues Switzerland can passively reach the WL an ultrasonic tip size 2002 reaches the WL minus 3 to 4 mm and the extra fine heat carrier tip taper 4 reaches the WL minus 4 to 5 mm were included in this study Pregnant women teeth with broken or immature apices resorption calcifications invading caries affecting the roots and abnormal mobility were excluded
Radiographic technique The included teeth were examined clinically and radiographically by using periapical radiography PA preoperatively T0 and at recall T3 T6 and T9 In order to take standardized radiographs throughout the experiment pretreatment bite blocks were fabricated using a bite registration material Kerr Corporation Romulus MI USA Figure 1 and PA were taken standardized paralleling technique with number 2 periapical film Durr Dental Bietigheim-Bissingen Germany mounted on the customized radiographic stent and connected to the X-ray tube Kodak RVG6100 Carestream Dental LLC Atlanta GA via an adapter ring The exposure parameters were 65 kV 75 mA and 015 seconds Three experienced endodontists graded blindly and independently the pre-operative PAI of each sample according to the classification of Ørstavik et al 1986 The lesion perimeter and area on the Xray were also measured in square and square millimeters respectively by using Image J 128 software version 148v National Institutes of Health Washington DC USA as previously described in multiple studies 71819 Freehand selection was used to trace out the border of the lesion and then measure and record the area value The examiners then met as a group to review all scores to enhance inter-rater agreement
Root canal procedure All treatments were performed in a single visit by a single endodontic postgraduate student The full endodontic procedure was performed under strict aseptic setting and a dental operating microscope Leica Microsystems Wetzlar Germany at a x64 magnification After confirming the clinical and radiological diagnosis both the crown of the tooth as well as the clamp and the rubber dam were disinfected using hydrogen peroxide 6 525 sodium hypochlorite and 10 sodium thiosulfate respectively
The access cavity was performed using sterile round diamond and endoZ burs Maillefer Ballaigues Switzerland mounted on a high-speed hand piece An apex locator Root ZX J Morita Corp Kyoto Japan and a size 15 stainless steel manual K-file Maillefer Ballaigues Switzerland were used to confirm the working length WL radiographically The tooth was excluded from the study if the manual K-file size 15 was unable to reach WL passively
The included teeth were randomly divided into 2 treatment groups by using random allocation software httpwwwrandomizationcom according to a standardized procedure 1 Group IHAN intracanal heating and passive ultrasonic activation of NaOCl only n16 the canal was irrigated with 5 mL room temperature 525 NaOCl using irriflex endodontic irrigation needle Produits Dentaires SA Vevey Switzerland mounted on a 3mL syringe Plastipak Franklin Lakes NJ USA PUA was performed using soft and flexible X silver tips size 202 length 21 mounted on an ultrasonic activator Eighteeth Changzhou Sifary Medical Technology Co Ltd Changzhou City China inserted in the canal to activate the solution Short vertical up and down strokes were achieved for 30 seconds without breaching apical 2 mm as manufacturers instructions After the first cycle of PUA an irriflex irrigation needle Produits Dentaires SA Vevey Switzerland mounted on a 3mL syringe Plastipak Franklin Lakes NJ USA was used to irrigate the canal with 5 mL of 17 ethylenediaminetetraacetic acid EDTA and kept in the canal for 60 seconds and then flushed out with 5 mL of saline The root canal was filled again with room temperature 525 sodium hypochlorite and heated in the canal for 10 seconds using extra-fine heat carrier 004 taper attached to a System B device Sybron dental Orange CA USA and moved with small in and out movements The temperature was fixed at 150 C Both ultrasonic tip and heat carrier were introduced into the un-instrumented canal until binding then withdrawn 2-3 mm prior to activation and heating to avoid their wedging in the canal Three consecutive cycles of PAU and intra-canal heating of sodium hypochlorite were performed A final rinse of 5mL 17 EDTA was performed for 60 seconds followed by 5 mL of saline
2 Group R-IHAN rotary instrumentation followed by intracanal heating and passive ultrasonic activation n16 Each canal was prepared using Reciproc Blue nickel titanium primary file 2508 VDW Munich Germany driven by a Xsmart IQ motor Dentsply Maillefer Ballaigues Switzerland according to the manufacturers instructions Continuous checking of the canal patency was done using size 10 handfile followed by irrigation with 3 mL room temperature 525 sodium hypochlorite using irriflex endodontic irrigation needle mounted on a 3mL syringe each time the rotary file was removed out of the canal Once the instrumentation was done the canal was irrigated with 5 mL of 17 ethylenediaminetetraacetic acid EDTA kept for 60 seconds and then flushed with 5 mL of saline NaOCl was placed in the canal and PUA followed by intracanal heating was performed three times as described for group 1 IHAN
After the completion of the endodontic procedures gauging of the apex using K-flexofiles Maillefer Ballaigues Switzerland was done each canal was dried with paper points and obturated with gutta-percha cones Produits Dentaires SA Vevey Switzerland and Kbiocer sealer Rekita Beirut Lebanon The largest well-adapted gutta-percha cone to the full WL without resistance was taken as master gutta-percha cone A layer of 1 mm of glass ionomer Fuji II LC Capsules GC America Alsip IL USA was placed over the gutta percha in the pulp chamber and covered by layer of temporary filling material A final periapical Xray was taken
- Evaluation Recall checkup appointments were regularly scheduled every 3-6- and 9 months 20-22 Much care was taken to reach a high recall rate Two patients out of 32 did not show on all the recall checkup appointments hence they were excluded from the study N30 making the n16 for IHAN and n14 for R-IHAN At recall examination pain swelling sinus tract gingival palpation tenderness to percussion and the quality of coronal restorations were recorded Post-operative standardized radiographs were taken in order to monitor the healing of the periapical lesion The lesion perimeter and area at the first visit were compared with those at recall and each sample was given a post-operation PAI at T9
Based on the area percentage change of lesions the treatment outcome was presented in four categories undetected lesion reduction enlargement or unchanged Reduction and enlargement of the radiolucency were determined only when the change in size of radiolucency was 20 or more 4142 An unchanged lesion was defined as a lesion change less than 20 18 Treatment outcome scores with PAI were adjusted to reflect clinical success PAI1 and PAI2 at follow-up uncertain PAI3 at follow-up for initial PAI45 and failure persisting PAI3 and any PAI4 or PAI5 at follow-up Failure was also recorded if the patient did not appear at any follow up recalls a tooth had been extracted or had evidence of a sinus tract involving the periapical area at recall 23 In order to assess the speed of repair of healedhealing periapical lesions 24 two formulas were used 1 Absolute speed of shrinkage mm2day initial detected area - final area duration of treatment 2 Relative speed of shrinkage day initial detected area - final area x 100 initial detected area x duration of treatment
Statistical analysis The IBM SPSS Statistics software version 250 was used for data analysis A P-value of less than 005 was considered statistically significant P005 Descriptive statistics were conducted quantitative variables are presented as means and standard deviations while qualitative variables are expressed as frequencies and percentages One-sample T-tests and Wilcoxon signed-rank tests were employed to compare the percentage change in perimeter surface and opacity with a 200 threshold at T3 Students T-tests and Mann-Whitney tests were utilized to identify significant differences in perimeter percentage change and surface percentage change between the techniques at T3 T6 and T9 A Friedman two-way test was employed to assess significant differences in perimeter and surface percentage change over time for the different techniques The Mann-Whitney test was also employed to assess differences in absolute and relative speed between the different techniques Chi-square or Fishers exact test was utilized to analyze the relationship between the technique and final observed changes in terms of perimeters surface as well as treatment outcome
Root canal instrumentation is primarily done to optimize irrigation and cleaning particularly in the apical region and to facilitate an hermetic obturation 56 However mechanical instrumentation is linked with multiple drawbacks including the production of dentin debris and smear layer the occurrence of iatrogenic errors root structure weakening and apical crack formation 7 It was also demonstrated that endodontic files are unable to touch the whole surface of the root canal walls due to the complexity of the root canal anatomy affecting the total cleaning and the final prognosis 8 Accordingly a variety of techniques and instruments can be used to render this step minimally invasive 9 as well as to improve the penetration of irrigants into the anatomical complexities 1011 Minimally invasive endodontics MIE involves minimum intervention using smaller size and taper rotating files in combination with more effective irrigation protocols 12
Ultrasonic activation of intracanal heated sodium hypochlorite NaOCl as a final irrigation protocol following root canal preparation showed superior bacterial reduction compared to canal preparation and NaOCl activation alone 13 Acoustic streaming and cavitation of heated irrigant are thought to be the working mechanisms 1415 Recent in vitro studies have argued whether such irrigation protocols could be suitable to disinfect non-instrumented and or minimally tapered root canals 61316
Until now no randomized clinical trials RCTs evaluated the in vivo efficacy of this protocol in un-instrumented canals In the absence of sufficient models for clinical outcomes only direct clinical studies evaluating both apical bone fill and tooth functionsurvival will offer compelling evidence regarding the efficacy of canal disinfection 4 Therefore the aim of this preliminary randomized clinical trial was to evaluate radiographically the healing of periapical lesions on single rooted teeth following a non-instrumentation technique using ultrasonic activation with intracanal heating of sodium hypochlorite IHAN compared to rotary canal instrumentation and ultrasonic activation with heating of NaOCl R-IHAN
- Sample size To determine the sample size a power analysis for repeated-measures ANOVA within-subjects factor with 4 measurements was conducted using GPower software 3197 for Windows Heinrich Heine Universitat Düsseldorf Düsseldorf Germany a power of 08 an alpha level of 005 were considered and an effect size of 035 was calculated based on a previous study conducted by van der Borden et al 34 The minimum sample size required is 13 periapical lesions per group 26 in total In order to account for losses to follow-up an attrition rate of 20 was added which results in a minimum total sample size of 32 16 per group
Patient Selection Based on a power analysis for repeated-measures ANOVA within-subjects factor with 4 measurements the minimum sample size required is 13 periapical lesions per group 26 in total In order to account for losses to follow-up an attrition rate of 20 was added which results in a minimum total sample size of 32 16 per group Patients with a noncontributory medical history were recruited at the Postgraduate Endodontics Clinic of the Faculty of Dentistry at the Saint Joseph University Beirut-Lebanon and were asked to sign a printed informed consent form after a detailed explanation of treatment procedures possible outcomes complications and follow-up period desired All selected teeth were single rooted maxillary and mandibular incisors canines or premolars with negative response on sensitivity testing and radiographic evidence of periapical bone loss of periapical index score PAI 3 according to the classification of Ørstavik et al 1986 Only root canals in which stainless steel Kfile size 15 Maillefer Ballaigues Switzerland can passively reach the WL an ultrasonic tip size 2002 reaches the WL minus 3 to 4 mm and the extra fine heat carrier tip taper 4 reaches the WL minus 4 to 5 mm were included in this study Pregnant women teeth with broken or immature apices resorption calcifications invading caries affecting the roots and abnormal mobility were excluded
Radiographic technique The included teeth were examined clinically and radiographically by using periapical radiography PA preoperatively T0 and at recall T3 T6 and T9 In order to take standardized radiographs throughout the experiment pretreatment bite blocks were fabricated using a bite registration material Kerr Corporation Romulus MI USA Figure 1 and PA were taken standardized paralleling technique with number 2 periapical film Durr Dental Bietigheim-Bissingen Germany mounted on the customized radiographic stent and connected to the X-ray tube Kodak RVG6100 Carestream Dental LLC Atlanta GA via an adapter ring The exposure parameters were 65 kV 75 mA and 015 seconds Three experienced endodontists graded blindly and independently the pre-operative PAI of each sample according to the classification of Ørstavik et al 1986 The lesion perimeter and area on the Xray were also measured in square and square millimeters respectively by using Image J 128 software version 148v National Institutes of Health Washington DC USA as previously described in multiple studies 71819 Freehand selection was used to trace out the border of the lesion and then measure and record the area value The examiners then met as a group to review all scores to enhance inter-rater agreement
Root canal procedure All treatments were performed in a single visit by a single endodontic postgraduate student The full endodontic procedure was performed under strict aseptic setting and a dental operating microscope Leica Microsystems Wetzlar Germany at a x64 magnification After confirming the clinical and radiological diagnosis both the crown of the tooth as well as the clamp and the rubber dam were disinfected using hydrogen peroxide 6 525 sodium hypochlorite and 10 sodium thiosulfate respectively
The access cavity was performed using sterile round diamond and endoZ burs Maillefer Ballaigues Switzerland mounted on a high-speed hand piece An apex locator Root ZX J Morita Corp Kyoto Japan and a size 15 stainless steel manual K-file Maillefer Ballaigues Switzerland were used to confirm the working length WL radiographically The tooth was excluded from the study if the manual K-file size 15 was unable to reach WL passively
The included teeth were randomly divided into 2 treatment groups by using random allocation software httpwwwrandomizationcom according to a standardized procedure 1 Group IHAN intracanal heating and passive ultrasonic activation of NaOCl only n16 the canal was irrigated with 5 mL room temperature 525 NaOCl using irriflex endodontic irrigation needle Produits Dentaires SA Vevey Switzerland mounted on a 3mL syringe Plastipak Franklin Lakes NJ USA PUA was performed using soft and flexible X silver tips size 202 length 21 mounted on an ultrasonic activator Eighteeth Changzhou Sifary Medical Technology Co Ltd Changzhou City China inserted in the canal to activate the solution Short vertical up and down strokes were achieved for 30 seconds without breaching apical 2 mm as manufacturers instructions After the first cycle of PUA an irriflex irrigation needle Produits Dentaires SA Vevey Switzerland mounted on a 3mL syringe Plastipak Franklin Lakes NJ USA was used to irrigate the canal with 5 mL of 17 ethylenediaminetetraacetic acid EDTA and kept in the canal for 60 seconds and then flushed out with 5 mL of saline The root canal was filled again with room temperature 525 sodium hypochlorite and heated in the canal for 10 seconds using extra-fine heat carrier 004 taper attached to a System B device Sybron dental Orange CA USA and moved with small in and out movements The temperature was fixed at 150 C Both ultrasonic tip and heat carrier were introduced into the un-instrumented canal until binding then withdrawn 2-3 mm prior to activation and heating to avoid their wedging in the canal Three consecutive cycles of PAU and intra-canal heating of sodium hypochlorite were performed A final rinse of 5mL 17 EDTA was performed for 60 seconds followed by 5 mL of saline
2 Group R-IHAN rotary instrumentation followed by intracanal heating and passive ultrasonic activation n16 Each canal was prepared using Reciproc Blue nickel titanium primary file 2508 VDW Munich Germany driven by a Xsmart IQ motor Dentsply Maillefer Ballaigues Switzerland according to the manufacturers instructions Continuous checking of the canal patency was done using size 10 handfile followed by irrigation with 3 mL room temperature 525 sodium hypochlorite using irriflex endodontic irrigation needle mounted on a 3mL syringe each time the rotary file was removed out of the canal Once the instrumentation was done the canal was irrigated with 5 mL of 17 ethylenediaminetetraacetic acid EDTA kept for 60 seconds and then flushed with 5 mL of saline NaOCl was placed in the canal and PUA followed by intracanal heating was performed three times as described for group 1 IHAN
After the completion of the endodontic procedures gauging of the apex using K-flexofiles Maillefer Ballaigues Switzerland was done each canal was dried with paper points and obturated with gutta-percha cones Produits Dentaires SA Vevey Switzerland and Kbiocer sealer Rekita Beirut Lebanon The largest well-adapted gutta-percha cone to the full WL without resistance was taken as master gutta-percha cone A layer of 1 mm of glass ionomer Fuji II LC Capsules GC America Alsip IL USA was placed over the gutta percha in the pulp chamber and covered by layer of temporary filling material A final periapical Xray was taken
- Evaluation Recall checkup appointments were regularly scheduled every 3-6- and 9 months 20-22 Much care was taken to reach a high recall rate Two patients out of 32 did not show on all the recall checkup appointments hence they were excluded from the study N30 making the n16 for IHAN and n14 for R-IHAN At recall examination pain swelling sinus tract gingival palpation tenderness to percussion and the quality of coronal restorations were recorded Post-operative standardized radiographs were taken in order to monitor the healing of the periapical lesion The lesion perimeter and area at the first visit were compared with those at recall and each sample was given a post-operation PAI at T9
Based on the area percentage change of lesions the treatment outcome was presented in four categories undetected lesion reduction enlargement or unchanged Reduction and enlargement of the radiolucency were determined only when the change in size of radiolucency was 20 or more 4142 An unchanged lesion was defined as a lesion change less than 20 18 Treatment outcome scores with PAI were adjusted to reflect clinical success PAI1 and PAI2 at follow-up uncertain PAI3 at follow-up for initial PAI45 and failure persisting PAI3 and any PAI4 or PAI5 at follow-up Failure was also recorded if the patient did not appear at any follow up recalls a tooth had been extracted or had evidence of a sinus tract involving the periapical area at recall 23 In order to assess the speed of repair of healedhealing periapical lesions 24 two formulas were used 1 Absolute speed of shrinkage mm2day initial detected area - final area duration of treatment 2 Relative speed of shrinkage day initial detected area - final area x 100 initial detected area x duration of treatment
Statistical analysis The IBM SPSS Statistics software version 250 was used for data analysis A P-value of less than 005 was considered statistically significant P005 Descriptive statistics were conducted quantitative variables are presented as means and standard deviations while qualitative variables are expressed as frequencies and percentages One-sample T-tests and Wilcoxon signed-rank tests were employed to compare the percentage change in perimeter surface and opacity with a 200 threshold at T3 Students T-tests and Mann-Whitney tests were utilized to identify significant differences in perimeter percentage change and surface percentage change between the techniques at T3 T6 and T9 A Friedman two-way test was employed to assess significant differences in perimeter and surface percentage change over time for the different techniques The Mann-Whitney test was also employed to assess differences in absolute and relative speed between the different techniques Chi-square or Fishers exact test was utilized to analyze the relationship between the technique and final observed changes in terms of perimeters surface as well as treatment outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None