Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870294
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2021-03-07
Brief Title:
Dental Cement in Post-operative Sensitivity Randomized Clinical Trial
Sponsor:
Universidade do Vale do Sapucai
Organization:
Universidade do Vale do Sapucai
Study Overview
Official Title:
PBS CIMMO DTA Cement in Post-operative Sensitivity Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Bioactivity
Brief Summary:
Context CEMENT PBS CIMMO DTA has physical and biological properties that classify it as a biocompatible material and inducer of biomineralization attributes that qualify it as material as an indirect pulp capper in permanent tooth restorations Objective The present clinical study proposes the use of PBS CIMMO DTA cement as an indirect pulp capper in resin restorations composed of permanent molars and premolars The objective was to minimize postoperative sensitivity arising from restorative procedures Method Randomized clinical trial with two arms double blind interventional prospective The sample consisted of 20 male patients with an average age of 20 years Totaling 70 teeth to be treated The teeth were divided into two groups Group R Control Group n 35 treated with a standard restorative procedure Group D Study group n 35 treated using CEMENT PBS CIMMO DTA as an indirect capper of the pulp wall The evaluation was carried out by a masked examiner for both groups Sensitivity tests were performed before the restorative procedure at 48 hours 7 15 and 30 days after the procedure The analysis included pain caused by thermal stimuli Cold Test TM horizontal TPH and vertical TPV percussion Bite Test TM and Pain Decline Time DD was measured Measured using Visual Analog Scale EVA
Detailed Description:
The present study is a clinical trial an intervention model prospective randomized double-blind patients and evaluator It was held at the Dental Office of the 14th Field Artillery Group - Pouso Alegre MG Military Organization of the Brazilian Army in conjunction with the University of Vale do Sapucaí UNIVÁS Pouso Alegre Minas Gerais Brazil in the period from 23 March 2020 to 18 January 2021
Participants were initially evaluated according to the inclusion and non-inclusion criteria of the research Clinical examinations were performed initially using a mouth mirror explorer probe Golgran São Caetano do Sul SP Brazil The data were recorded on clinical records for screening The radiographic examination included performing periapical radiographs as diagnostic aids for participants who met the inclusion criteria during the clinical examination Oral hygiene guidelines were provided to all research participants To begin the service an anamnesis form was filled out
Randomization occurred after applying the inclusion and non-inclusion criteria of the patients 20 were selected according to the initial clinical examination
The 20 patients were randomized and the random sequence for submission to radiographic examinations was determined defining 70 teeth to be treated within the study criteria
As for the group that each tooth would belong to 70 brown envelopes were made 35 containing green paper belonging to the standard restorative procedure group and 35 containing pink paper belonging to the DTA group Before starting the procedure for each tooth the patient was asked to choose the envelope Thus the sequence of treatments was determined The envelopes chosen for each treatment were discarded
The teeth grouped in group R were treated with composite resin restoration without liner material considered a control group
The teeth grouped in group D received PBS CIMMO DTA as indirect capping material of the cavity followed by restoration of composite resin
Sensitivity tests
Before starting the restorative treatment dental sensitivity assessment was performed Cold test Using cotton in Cremer balls safe in clinical forceps Duflex cooled with fluorethane gas applied over the buccal surface of the tooth for 15s or until patient indicates painful sensation Endo Ice Spray Maquira for the Cold Test The time from the beginning of the stimulus until its disappearance was counted Time of Decline of pain Percussion test With the aid of the mouth mirror handle Duflex the tooth was touched with light taps in the occlusal-apical and vestibule-lingual vestibule-palate directions Masticatory strength test The patient performed masticatory movements under a bite device Indusbello Londrina PR Brazil The patients perceptions of sensitivity were checked on a scale from 0 to 10 using the Visual Analogue Scale VAS
Restorative procedures
Pumice prophylaxis SS White Rio de Janeiro RJ Brazil and water were initially performed in order to remove residues and or dental biofilm Proceeding to the stage of topical anesthesia Benzotop 200mg DFL Jacarepaguá RJ Brazil followed by local infiltrative anesthesia Alphacaine 2 DFL Jacarepaguá RJ Brazil and absolute isolation of the operative field
It should be noted that the absolute isolation was performed prior to the cavity preparation following the sanitary rules Covid 19 to contain aerosols caused by the use of high speed
The operative procedure was performed initially with spherical diamond tips KG Sorensen Cotia SP Brazil numbering compatible with the carious lesion 1011 1012 1013 1014 1016 until reaching the caries carefully so as not to remove structure healthy dental Then carbide steel spherical drills numbering compatible with the lesion no 2 4 or 6 KG Sorensen Cotia SP Brazil were used at low speed Contra-angle Kavo Joinville PR Brazil to remove carious tissue Each diamond tip and Carbide drill was used a maximum of 4 times after which they were discarded
For restorations that needed to restore the shape of the proximal walls wedges preformed metal matrices and staples Unimatrix TDV Pomerode-SC-Brasil were used
Subsequently the cavities were restored as described below
In group R teeth the following operative step was performed
Conditioning with 37 phosphoric acid Condac 37 FGM Joinville SC Brazil was performed for 30 seconds on enamel and 15 seconds on dentin Then the cavity was washed with the aid of a triple syringe using an air water jet for 10 seconds
The cavities received the restorative system composed of the Adper Single Bond2 adhesive and the nano-particulate resin Filtek Z350XT 3M ESPE Dental Products TM St Paul MN USA The dentin substrate was left slightly moist with the aid of cotton in Cremer balls Adhesive material was used using a Cavibrush microbrush brush FGM Joinville SC Brazil strictly following the manufacturers rules used for this purpose saturated for each covering two consecutive layers of the enamel and dentin adhesive were applied waited 30 seconds continued with light air jets for 5 seconds and then the photoactivation was performed for 10 seconds with LED Poly Wireless Kavo Joinville-SC-Brazil with a power of 600 50 mW cm²
The restorations were performed using the composite resin Filtek Z350 XT 3M ESPE Dental Products TM St Paul MN USA using the incremental oblique technique in increments of a maximum of 2 mm in thickness and each increment was photoactivated by 20 seconds with LED Poly Wireless Kavo Joinville SC Brazil final polymerization for 40s
After the restorations were completed absolute isolation was removed then the sculpture was refined and occlusal adjustment was carried out immediate finishing with thin diamond tips number 2135F 3118F and 3195F KG Sorensen Cotia SP Brazil depending of the restored anatomical region Polishing was carried out with abrasive silicone polishers for resins Microdont Camanducaia SP-Brazil in medium yellow and superfine white granules and felt disc Diamond FGM with diamond paste Diamond Excel FGM Joinville SC Brazil
In group D teeth the same restorative step was also carried out but prior to the acid conditioning step PBS CIMMO DTA cement was applied as a base for the dental cavity following the manufacturers instructions
The PBS CIMMO DTA Cement was handled in a sterile glass plate and spatula 24 Duflex a portion of the cement powder and a drop of distilled water were dispensed 1 1 ratio Then the manipulated material was inserted with the aid of a dentin spoon Duflex to the pulp wall of the cavity preparation Using clinical forceps Duflex and cotton in Cremer balls the cement was condensed at the bottom of the cavity obtaining adaptation and removing excess moisture Then acid conditioning adhesive application restorative technique and polishing were performed as previously recommended for group R
Clinical evaluations
The research participants had their personal records anamnesis as well as the type of treatment proposed inserted in a clinical form However only the operator who performed the restorative procedures had access to them In another form the values obtained in the Sensitivity Tests at 5 different moments were noted The first tests performed in the preoperative period and the others in the postoperative period The evaluations were performed by a single examiner trained by the researcher and not involved with the restorative procedures The evaluations were noted on a specific form Appendix B The examiner was kept blind in all assessments
It is noteworthy that due to the health requirements imposed by the pandemic Covid 19 the evaluations were carried out by a single evaluator
Sensitivity assessment
Sensitivity tests were performed before the restorative procedure at 48 hours 7 15 and 30 days post-procedures The analysis included pain caused by thermal stimuli percussion and bite
For the thermal test cotton was used in Cremer balls secured by clinical forceps Duflex cooled with fluorethane gas Endo Ice Spray Maquira and applied over the buccal surface of the treated tooth for 15s or even the patient indicates painful sensation In the percussion test with the aid of the mouth mirror handle Duflex touches were made on the tooth with light taps in the occlusal-apical and vestibule-lingual vestibule-palate directions For the test of masticatory forces the patient performed masticatory movements under a bite device Indusbello Londrina PR Brazil
The patients received a Visual Analogue Scale VAS AMARAL and CALASANS 2013 Figure 1 Sensitivity perceptions were cataloged from 0 to 10 The scores determined were 0 no pain 1 to 2 mild pain 3 to 5 moderate pain 6 to 7 moderate pain slightly worse 8 to 9 severe pain 10 maximum pain
The analyzes were tabulated in Microsoft exel and sent for statistical procedures
Participants were initially evaluated according to the inclusion and non-inclusion criteria of the research Clinical examinations were performed initially using a mouth mirror explorer probe Golgran São Caetano do Sul SP Brazil The data were recorded on clinical records for screening The radiographic examination included performing periapical radiographs as diagnostic aids for participants who met the inclusion criteria during the clinical examination Oral hygiene guidelines were provided to all research participants To begin the service an anamnesis form was filled out
Randomization occurred after applying the inclusion and non-inclusion criteria of the patients 20 were selected according to the initial clinical examination
The 20 patients were randomized and the random sequence for submission to radiographic examinations was determined defining 70 teeth to be treated within the study criteria
As for the group that each tooth would belong to 70 brown envelopes were made 35 containing green paper belonging to the standard restorative procedure group and 35 containing pink paper belonging to the DTA group Before starting the procedure for each tooth the patient was asked to choose the envelope Thus the sequence of treatments was determined The envelopes chosen for each treatment were discarded
The teeth grouped in group R were treated with composite resin restoration without liner material considered a control group
The teeth grouped in group D received PBS CIMMO DTA as indirect capping material of the cavity followed by restoration of composite resin
Sensitivity tests
Before starting the restorative treatment dental sensitivity assessment was performed Cold test Using cotton in Cremer balls safe in clinical forceps Duflex cooled with fluorethane gas applied over the buccal surface of the tooth for 15s or until patient indicates painful sensation Endo Ice Spray Maquira for the Cold Test The time from the beginning of the stimulus until its disappearance was counted Time of Decline of pain Percussion test With the aid of the mouth mirror handle Duflex the tooth was touched with light taps in the occlusal-apical and vestibule-lingual vestibule-palate directions Masticatory strength test The patient performed masticatory movements under a bite device Indusbello Londrina PR Brazil The patients perceptions of sensitivity were checked on a scale from 0 to 10 using the Visual Analogue Scale VAS
Restorative procedures
Pumice prophylaxis SS White Rio de Janeiro RJ Brazil and water were initially performed in order to remove residues and or dental biofilm Proceeding to the stage of topical anesthesia Benzotop 200mg DFL Jacarepaguá RJ Brazil followed by local infiltrative anesthesia Alphacaine 2 DFL Jacarepaguá RJ Brazil and absolute isolation of the operative field
It should be noted that the absolute isolation was performed prior to the cavity preparation following the sanitary rules Covid 19 to contain aerosols caused by the use of high speed
The operative procedure was performed initially with spherical diamond tips KG Sorensen Cotia SP Brazil numbering compatible with the carious lesion 1011 1012 1013 1014 1016 until reaching the caries carefully so as not to remove structure healthy dental Then carbide steel spherical drills numbering compatible with the lesion no 2 4 or 6 KG Sorensen Cotia SP Brazil were used at low speed Contra-angle Kavo Joinville PR Brazil to remove carious tissue Each diamond tip and Carbide drill was used a maximum of 4 times after which they were discarded
For restorations that needed to restore the shape of the proximal walls wedges preformed metal matrices and staples Unimatrix TDV Pomerode-SC-Brasil were used
Subsequently the cavities were restored as described below
In group R teeth the following operative step was performed
Conditioning with 37 phosphoric acid Condac 37 FGM Joinville SC Brazil was performed for 30 seconds on enamel and 15 seconds on dentin Then the cavity was washed with the aid of a triple syringe using an air water jet for 10 seconds
The cavities received the restorative system composed of the Adper Single Bond2 adhesive and the nano-particulate resin Filtek Z350XT 3M ESPE Dental Products TM St Paul MN USA The dentin substrate was left slightly moist with the aid of cotton in Cremer balls Adhesive material was used using a Cavibrush microbrush brush FGM Joinville SC Brazil strictly following the manufacturers rules used for this purpose saturated for each covering two consecutive layers of the enamel and dentin adhesive were applied waited 30 seconds continued with light air jets for 5 seconds and then the photoactivation was performed for 10 seconds with LED Poly Wireless Kavo Joinville-SC-Brazil with a power of 600 50 mW cm²
The restorations were performed using the composite resin Filtek Z350 XT 3M ESPE Dental Products TM St Paul MN USA using the incremental oblique technique in increments of a maximum of 2 mm in thickness and each increment was photoactivated by 20 seconds with LED Poly Wireless Kavo Joinville SC Brazil final polymerization for 40s
After the restorations were completed absolute isolation was removed then the sculpture was refined and occlusal adjustment was carried out immediate finishing with thin diamond tips number 2135F 3118F and 3195F KG Sorensen Cotia SP Brazil depending of the restored anatomical region Polishing was carried out with abrasive silicone polishers for resins Microdont Camanducaia SP-Brazil in medium yellow and superfine white granules and felt disc Diamond FGM with diamond paste Diamond Excel FGM Joinville SC Brazil
In group D teeth the same restorative step was also carried out but prior to the acid conditioning step PBS CIMMO DTA cement was applied as a base for the dental cavity following the manufacturers instructions
The PBS CIMMO DTA Cement was handled in a sterile glass plate and spatula 24 Duflex a portion of the cement powder and a drop of distilled water were dispensed 1 1 ratio Then the manipulated material was inserted with the aid of a dentin spoon Duflex to the pulp wall of the cavity preparation Using clinical forceps Duflex and cotton in Cremer balls the cement was condensed at the bottom of the cavity obtaining adaptation and removing excess moisture Then acid conditioning adhesive application restorative technique and polishing were performed as previously recommended for group R
Clinical evaluations
The research participants had their personal records anamnesis as well as the type of treatment proposed inserted in a clinical form However only the operator who performed the restorative procedures had access to them In another form the values obtained in the Sensitivity Tests at 5 different moments were noted The first tests performed in the preoperative period and the others in the postoperative period The evaluations were performed by a single examiner trained by the researcher and not involved with the restorative procedures The evaluations were noted on a specific form Appendix B The examiner was kept blind in all assessments
It is noteworthy that due to the health requirements imposed by the pandemic Covid 19 the evaluations were carried out by a single evaluator
Sensitivity assessment
Sensitivity tests were performed before the restorative procedure at 48 hours 7 15 and 30 days post-procedures The analysis included pain caused by thermal stimuli percussion and bite
For the thermal test cotton was used in Cremer balls secured by clinical forceps Duflex cooled with fluorethane gas Endo Ice Spray Maquira and applied over the buccal surface of the treated tooth for 15s or even the patient indicates painful sensation In the percussion test with the aid of the mouth mirror handle Duflex touches were made on the tooth with light taps in the occlusal-apical and vestibule-lingual vestibule-palate directions For the test of masticatory forces the patient performed masticatory movements under a bite device Indusbello Londrina PR Brazil
The patients received a Visual Analogue Scale VAS AMARAL and CALASANS 2013 Figure 1 Sensitivity perceptions were cataloged from 0 to 10 The scores determined were 0 no pain 1 to 2 mild pain 3 to 5 moderate pain 6 to 7 moderate pain slightly worse 8 to 9 severe pain 10 maximum pain
The analyzes were tabulated in Microsoft exel and sent for statistical procedures
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