Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03064516
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2017-02-22
Brief Title:
Endocrowns vsCeramic Onlays Used in Endodontically Treated Teeth- Randomized Clinical Study
Sponsor:
Susana Morimoto
Organization:
Universidade Ibirapuera
Study Overview
Official Title:
Endocrowns vsCeramic Onlays With Filling and Fiber Pins Used in Endodontically Treated Teeth- Randomized Clinical Study
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Objective To evaluate the immediate and mediate outcomes of endocrowns and onlay ceramic restorations with glass fiber pin in endodontically treated teeth Material and methods A randomized controlled clinical trial a double-blind patient and examiner is conducted by one trained and calibrated operators who perform all restorative procedures The restorations are evaluated longitudinally by a blind and calibrated examiner using the USPHS A total of 20 patients will be randomly assigned to each group for a total of 40 patients The randomization sequence will be generated wwwsealedenvelopecom and to ensure the confidentiality of the allocation this will be used opaque sealed and numbered envelopes in series These will be kept with an independent researcher for the moment of inclusion of the subjects In the group of onlays the teeth receive a fiberglass pin in the main root canal and composite resin filling In the group of endocrown only the restoration fill the pulp chamber The parts are milled in IPS e-max CAD Ivoclar Vivadent and cemented with the Multilink cementation system Ivoclar Vivadent The immediate clinical focused in restoration and patient and mediate radiographic and clinical outcomes will be compared between the groups Survival and success rates will be defined in 24 months Survival will be established by Kaplan-Meier survival curve and log-rank can be conducted to identify as variables associated with as failures over time Multivariate analysis with the Cox regression models will be condutcted for the determination of failure predictors For all analyzes the significance value will be adjusted to 5
Detailed Description:
Study design - ethical and methodological aspects This study is an integral part of an umbrella project in which the primary outcome is the longevity of prosthetic treatments whereas patient-centered secondary outcomes are dealt with in the current study The study protocol was approved by the Research Ethics Committee following the Consolidated Standards of Reporting of Trials CONSORT and CONSORT PRO guidelines Calvert et al 2013 Moher et al 2012 and registered at clinicaltrialsgov NCT03064516
This double-blind parallel-arm randomized clinical trial with a 11 allocation ratio was conducted by a previously trained operator who performed all the restorative procedures
Survival rate of inlayonlay ceramic restorations 966 after 24 months was the primary outcome considered for sample size calculation Peumans et al 2010 Therefore a clinically significant difference of 15 is expected for longevity between the groups So adopting a significance level of 005 and a 080 power considering one tooth per patient and using a two-tailed test for noninferiority trials adding 20 for possible losses dropout the final number of teeth per group was 20 corresponding to a total of 40 teeth
Participants - recruitment eligibility randomization and allocation The patients were recruited by one of the researchers SM based on history-taking clinical examination and radiographic exams using a sample of patients from the Military Police Dental Center São Paulo Brazil treated in 2017 The clinical steps were carried out in a private dental office
Eligible patients were randomly assigned to one of the parallel arms of the study The randomization sequence was generated wwwsealedenvelopecom and allocation concealment was ensured by the use of sealed brown envelopes numbered serially and kept in possession of an independent researcher until they were opened by the operator at the beginning of treatment The contents of the envelope indicated the experimental group to which the patient would be assigned Endocrown group test or Partial coverage ceramic restoration fiber post group PCCRpost- control
Restorative techniques for the experimental groups All participants received instructions on oral hygiene and diet Radiographs were taken at baseline and after cementation Photographs were taken at baseline after removal of the carious tissue and of old restorations after cavity preparation and after cementation Procedure time was recorded in sessions 1 and 2 beginning with preoperative mouth rinsing and ending with occlusal adjustment session 1 and beginning with preoperative mouth rinsing and ending with final radiograph session 2
Session 1- Cavity preparation and casting Endocrown group- Well-defined cervical chamfered finish lines should be created to facilitate the impression and technical procedures thus a 2-mm round-ended chamfer finish line was created along the margin using tapered inverted cone diamond burs at high rotation and under cooling against a 15 contra angle multiplier S-MAX M95L- NSK No filling was used the space of the pulp chamber is included in the preparation
PCCRPost group- A fiber post White post FGM whose size was compatible with the main canal was luted reaching approximately half of the canal The post was cleaned with alcohol dried and treated with Monobond Ivoclar Vivadent Multilink was applied to the tooth Ivoclar Vivadent mixing it with primer AB at a 11 ratio without previous acid etching with a brief air jet After that the post was luted with Multilink resin cement Ivoclar Vivadent followed by photopolymerization for 20 seconds and filling with composite resin - shade A2 Tetric N Ceram bulk fill- Ivoclar Vivadent in 1-2 mm increments and photopolymerization for 20 seconds per layer Occlusal and proximal boxes were prepared not exceeding 2 mm in ceramic thickness A 2-mm round-ended chamfer finish line was created along the margin of extracoronal areas using tapered inverted cone diamond burs at high rotation and under cooling against a 15 contra angle multiplier 15 S-Max M95L NSK
In both groups the cusps were preserved whenever possible but in cases where veneering was needed the occlusal surface was abraded to allow for a 15-to-2 mm space If necessary the proximal contact point was removed with metal files
The double-cord technique Ultrapack- Ultradent and double molding technique were used Virtual heavy and regular body - Ivoclar Vivadent The color was chosen using the Vita classical shade guide Vita Zahnfabrik The provisional restorations were fabricated with acrylic resin and cemented with Temp Bond NE Kerr Corporation
Laboratory phase - ceramic restoration manufacture The specimens were fabricated with lithium disilicate glass ceramic IPS emax CAD- Ivoclar Vivadent and milled Cerec In Lab Mcxl producing a monolithic restoration which was tinted and glazed
Session 2- Testing fitting and cementation of the ceramic restoration After testing and fitting of the specimen in the mouth rubber dam isolation was used for adhesive cementation in both groups as follows the enamel and dentin were etched with 37 phosphoric acid gel N-etch Ivoclar Vivadent for 15-20 seconds followed by copious rinsing and brief air jets The specimens were etched with 5 hydrofluoric acid IPS Ceramic Etching Gel Ivoclar Vivadent silanized for 1 min Monobond N Ivoclar Vivadent and luted with Tetric N-bond and Multilink N dual cement Ivoclar Vivadent Photoactivation was performed with a Radii-Cal device SDI- 1200 mWcm2 for 20 seconds on each surface Occlusal adjustment was performed and the restorations were polished with rubber points Optra Fine Ivoclar Vivadent at low speed under cooling
Patient-centered outcomes
Endodontic treatments had been carried out by different dentists on dates that could not be clearly specified by the patients Patient-reported outcome measures PROMs include self-administered questionnaires with the purpose of evaluating psychometric data in addition to history taking and demographic and clinical data The questionnaires described next were handed out to participants by an external examiner in the absence of the operator
Patient satisfaction questionnaire Mattos-Silveira et al 2015 - The patient was asked to give hisher real opinion about the treatment and to indicate how satisfied heshe was on a 0-3 scale 0 - excellent 1- good 2- acceptable 3- not satisfied
Visual analog scale- Used to assess patient discomfortpain immediately after the end of sessions 1 and 2 This scale consists of a 10-cm 100-mm horizontal line with no sensitivity written on one end and maximum sensitivity on the other one The patient was asked to draw a vertical line on the horizontal scale to indicate hisher level of discomfortpain After that the distance in mm from the starting point no sensitivity to the vertical line drawn by the patient was measured with a ruler 0 to 100 mm The recorded values were interpreted as follows 0-4 mm no discomfort 5-44 mm mild discomfort 45-74 mm moderate discomfort 75-100 maximum discomfort
Statistical analysis The data were assessed by SPSS V16 for Windows SPSS Chicago IL USA Poisson regression analysis was used to compare patient discomfort between the groups and to evaluate the influence of explanatory variables on the discomfort reported by patients age and sex tooth type of restorative treatment number of treated surfaces presence of endodontic lesion and procedure time At first an unadjusted Poisson regression analysis was performed for each explanatory variable and values with p020 were included in the adjusted regression model Only those variables with p005 were kept in the final model Prevalence ratios PR were calculated using a 95 confidence interval 95CI As the level of satisfaction was 100 for score 0 it was not possible to conduct a statistical analysis Two-way repeated-measures analysis of variance - experimental group and time - was used to estimate the difference in procedure time between the experimental groups Kaplan Meyer will be performed to survival analysis
In all analyses the significance level was set at 5
This double-blind parallel-arm randomized clinical trial with a 11 allocation ratio was conducted by a previously trained operator who performed all the restorative procedures
Survival rate of inlayonlay ceramic restorations 966 after 24 months was the primary outcome considered for sample size calculation Peumans et al 2010 Therefore a clinically significant difference of 15 is expected for longevity between the groups So adopting a significance level of 005 and a 080 power considering one tooth per patient and using a two-tailed test for noninferiority trials adding 20 for possible losses dropout the final number of teeth per group was 20 corresponding to a total of 40 teeth
Participants - recruitment eligibility randomization and allocation The patients were recruited by one of the researchers SM based on history-taking clinical examination and radiographic exams using a sample of patients from the Military Police Dental Center São Paulo Brazil treated in 2017 The clinical steps were carried out in a private dental office
Eligible patients were randomly assigned to one of the parallel arms of the study The randomization sequence was generated wwwsealedenvelopecom and allocation concealment was ensured by the use of sealed brown envelopes numbered serially and kept in possession of an independent researcher until they were opened by the operator at the beginning of treatment The contents of the envelope indicated the experimental group to which the patient would be assigned Endocrown group test or Partial coverage ceramic restoration fiber post group PCCRpost- control
Restorative techniques for the experimental groups All participants received instructions on oral hygiene and diet Radiographs were taken at baseline and after cementation Photographs were taken at baseline after removal of the carious tissue and of old restorations after cavity preparation and after cementation Procedure time was recorded in sessions 1 and 2 beginning with preoperative mouth rinsing and ending with occlusal adjustment session 1 and beginning with preoperative mouth rinsing and ending with final radiograph session 2
Session 1- Cavity preparation and casting Endocrown group- Well-defined cervical chamfered finish lines should be created to facilitate the impression and technical procedures thus a 2-mm round-ended chamfer finish line was created along the margin using tapered inverted cone diamond burs at high rotation and under cooling against a 15 contra angle multiplier S-MAX M95L- NSK No filling was used the space of the pulp chamber is included in the preparation
PCCRPost group- A fiber post White post FGM whose size was compatible with the main canal was luted reaching approximately half of the canal The post was cleaned with alcohol dried and treated with Monobond Ivoclar Vivadent Multilink was applied to the tooth Ivoclar Vivadent mixing it with primer AB at a 11 ratio without previous acid etching with a brief air jet After that the post was luted with Multilink resin cement Ivoclar Vivadent followed by photopolymerization for 20 seconds and filling with composite resin - shade A2 Tetric N Ceram bulk fill- Ivoclar Vivadent in 1-2 mm increments and photopolymerization for 20 seconds per layer Occlusal and proximal boxes were prepared not exceeding 2 mm in ceramic thickness A 2-mm round-ended chamfer finish line was created along the margin of extracoronal areas using tapered inverted cone diamond burs at high rotation and under cooling against a 15 contra angle multiplier 15 S-Max M95L NSK
In both groups the cusps were preserved whenever possible but in cases where veneering was needed the occlusal surface was abraded to allow for a 15-to-2 mm space If necessary the proximal contact point was removed with metal files
The double-cord technique Ultrapack- Ultradent and double molding technique were used Virtual heavy and regular body - Ivoclar Vivadent The color was chosen using the Vita classical shade guide Vita Zahnfabrik The provisional restorations were fabricated with acrylic resin and cemented with Temp Bond NE Kerr Corporation
Laboratory phase - ceramic restoration manufacture The specimens were fabricated with lithium disilicate glass ceramic IPS emax CAD- Ivoclar Vivadent and milled Cerec In Lab Mcxl producing a monolithic restoration which was tinted and glazed
Session 2- Testing fitting and cementation of the ceramic restoration After testing and fitting of the specimen in the mouth rubber dam isolation was used for adhesive cementation in both groups as follows the enamel and dentin were etched with 37 phosphoric acid gel N-etch Ivoclar Vivadent for 15-20 seconds followed by copious rinsing and brief air jets The specimens were etched with 5 hydrofluoric acid IPS Ceramic Etching Gel Ivoclar Vivadent silanized for 1 min Monobond N Ivoclar Vivadent and luted with Tetric N-bond and Multilink N dual cement Ivoclar Vivadent Photoactivation was performed with a Radii-Cal device SDI- 1200 mWcm2 for 20 seconds on each surface Occlusal adjustment was performed and the restorations were polished with rubber points Optra Fine Ivoclar Vivadent at low speed under cooling
Patient-centered outcomes
Endodontic treatments had been carried out by different dentists on dates that could not be clearly specified by the patients Patient-reported outcome measures PROMs include self-administered questionnaires with the purpose of evaluating psychometric data in addition to history taking and demographic and clinical data The questionnaires described next were handed out to participants by an external examiner in the absence of the operator
Patient satisfaction questionnaire Mattos-Silveira et al 2015 - The patient was asked to give hisher real opinion about the treatment and to indicate how satisfied heshe was on a 0-3 scale 0 - excellent 1- good 2- acceptable 3- not satisfied
Visual analog scale- Used to assess patient discomfortpain immediately after the end of sessions 1 and 2 This scale consists of a 10-cm 100-mm horizontal line with no sensitivity written on one end and maximum sensitivity on the other one The patient was asked to draw a vertical line on the horizontal scale to indicate hisher level of discomfortpain After that the distance in mm from the starting point no sensitivity to the vertical line drawn by the patient was measured with a ruler 0 to 100 mm The recorded values were interpreted as follows 0-4 mm no discomfort 5-44 mm mild discomfort 45-74 mm moderate discomfort 75-100 maximum discomfort
Statistical analysis The data were assessed by SPSS V16 for Windows SPSS Chicago IL USA Poisson regression analysis was used to compare patient discomfort between the groups and to evaluate the influence of explanatory variables on the discomfort reported by patients age and sex tooth type of restorative treatment number of treated surfaces presence of endodontic lesion and procedure time At first an unadjusted Poisson regression analysis was performed for each explanatory variable and values with p020 were included in the adjusted regression model Only those variables with p005 were kept in the final model Prevalence ratios PR were calculated using a 95 confidence interval 95CI As the level of satisfaction was 100 for score 0 it was not possible to conduct a statistical analysis Two-way repeated-measures analysis of variance - experimental group and time - was used to estimate the difference in procedure time between the experimental groups Kaplan Meyer will be performed to survival analysis
In all analyses the significance level was set at 5
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