Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325540
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-06
Brief Title:
Clinical Success of Indirect Pulp Capping 1-Year Follow-Up
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Saglik Bilimleri Universitesi
Study Overview
Official Title:
Clinical Success of Indirect Pulp Capping Using Biodentine Theracal PT and Therabase in Primary Molars 1-Year Follow-Up
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to compare the clinical success of theracal pt therabase and biodentine indirect pulp capping on primary molars with deep dentin caries Indirect pulp capping was used on the primary molars of the participants with deep dentin caries It is aimed to compare the success of biodentine which is considered the gold standard used in capping treatments and the currently marketed Teracal PT and Therabase materials after 1 6 months and 1 year with biodentine and with each other and find out which material is more successful
Detailed Description:
This study utilized a parallel group randomized controlled design and enrolled patients who visited the Department of Pediatric Dentistry Health Sciences University İstanbul Turkey in the period of 2020-2022 The study protocol was approved by the Health Sciences University Hamidiye Clinical Research Ethics Committee 734
All procedures were conducted in accordance with the ethical standards of the relevant national and institutional committees on human experimentation with the Helsinki Declaration of 1975 as revised in 2013 The parents or legal guardians provided written in formed consent
The sample size was calculated using a GPower program Gpower 31 version for the distribution of the success rates in the Biodentine Therabase and TheraCal PT groups regarding the follow-up periods the following parameters were used medium effect size f 034 error 005 minimum 80 power Based on these parameters the total sample size was calculated as 28 participants for each group
This study was conducted as a prospective clinical and radiographic evaluation A total of 76 teeth first and second primary molars from 5- to 9-year-old healthy and cooperative children with nonclinical and radiographic evidence of infection symptoms and with indications for indirect pulp treatment were included in this study The teeth were divided into three groups according to the pulp capping materials
Inclusion and exclusion criteria
Healthy patients aged 5-9 years were recruited from the pediatric dental clinic at Health Sciences University Based on the clinical and radiographic examinations the inclusion criteria were previously untreated first and second primary molars in cooperative children with good general health which had deep dentin caries involving occluso-proximal surfaces but showed positive response to vitality tests electrical pulp test and cold stimulation Endo Ice Hygienic ColteneWhaledent AG Altstatten Switzerland and Diagnostic Unit SybronEndo Orange CA were radiographically detected with caries penetration involving approximately 34 of the dentin thickness were considered to have a potential to result in pulp exposure when the entire caries was cleared according to the complete excavation procedure in which the end point of carious tissue removal is the hard dentin and showed a moderate response to chemical and thermal stimuli Clinical success criteria were as follows signs of irreversible pulpitis such as spontaneous pain prolonged pain response presence of percussion or palpation pathological mobility infectious symptoms such as fistula or abscess and discoloration in the clinical examination Radiographic success criteria included presence of radiolucency in the furcation or periapical regions thickening of the periodontal spaces and internal or external root resorption
Clinical practice
Two pediatric dentists screened each patient for inclusion and exclusion criteria during a preoperative oral examination and participants that met the inclusion criteria were randomly divided into three groups Biodentine group n 25 TheraCal PT group n26 Therabase group n 25
Following the application of topical and local anaesthesia injection 2 lidocaine hydrochloride with epinephrine 180000 Septodont Saint-Maur-des-Fosses France rubber-dam isolation Dental Dam Coltène Whaledent Langenau Germany were performed The tooth was disinfected by scrubbing with 2 chlorhexidine The carious peripheral dentin was removed using a high-speed dental diamond bur Dentsply Dentsply Maillefer Baillaigues Switzerland and the infected and necrotic soft dentin layer in the center was carefully removed to prevent pulp exposure Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation and the demineralized dentin affected dentin was left at the floor of the cavity After removal of carious the cavities were washed with 2 chlorhexidine gluconate irrigation solution Klorhex Drogsan Türkiye and then were dried with an air-water spray and cotton pellets Biodentine TheraCal PT and Therabase materials were applied according to the manufacturers instructions
Biodentine group The entire residual demineralized dentin tissue covered with approximately 1mm tricalcium silicate pulp-capping material Biodentine SeptodontSaint-Maur-des-FossésFrance by avoiding the placement of the material on enamel or margins of the cavity After application of Biodentin 12-min setting time was allowed for setting in accordance with the recommendations of the manufacturer
Theracal PT group The entire residual demineralized dentin tissue covered with maximum thickness of 1mm flowable form of resin-modified calcium silicate-containing material TheraCal PTBisco IncSchaumburgILUSA by avoiding the placement of the material on enamel or margins of the cavity After appllication of TheraCal PT the polymerization for 20s Elipar Deep Cure 3 M ESPE St Paul MN USA in accordance with the recommendations of the manufacturer
Therabase group The entire residual demineralized dentin tissue covered with maximum thickness of 1mm flowable form of dual-cured calcium and fluoride releasing self-adhesive baseliner material Therabase Therabase PTBisco IncSchaumburgILUSA by avoiding the placement of the material on enamel or margins of the cavity After appllication of TheraCal PT the polymerization for 20s Elipar Deep Cure 3 M ESPE St Paul MN USA in accordance with the recommendations of the manufacturer
Afterwards in all three groups glass ionomer cement consisting of powder and liquid Ketac Molar Easy Mix 3M ESPE Germany was placed on each capping material Following the etching and bonding process permanent restoration was finished with composite resin Filtek Z250 Universal Restorative System 3M ESPE DentalProducts USA
Clinical and radiographic examination The patients were called for follow-up at 1 months 6 months and 1 year during the first year At each follow-up visit a clinical examination was performed to assess the presence of tenderness to percussion or palpation spontaneous pain or prolonged pain response discoloration infectious symptoms such as fistula or abscess and pathological mobility Additionally a radiographic examination was performed to assess the presence of lesions in the furcation or periapical regions internal or external root resorption and thickening of the periodontal spaces The teeth detected with at least one of these findings were considered unsuccessful
Statistical analysis All statistical analyses were performed by using software SPSS IBM SPSS Statistics 2022 Normality and homegenity of the data were evaluated by using Kolmogorov-Smirnov and Levenes Homogeneity tests Pearson chi-square and Kruskall-Wallis H tests were performed to analyze data at the 95 confidence level P 005
All procedures were conducted in accordance with the ethical standards of the relevant national and institutional committees on human experimentation with the Helsinki Declaration of 1975 as revised in 2013 The parents or legal guardians provided written in formed consent
The sample size was calculated using a GPower program Gpower 31 version for the distribution of the success rates in the Biodentine Therabase and TheraCal PT groups regarding the follow-up periods the following parameters were used medium effect size f 034 error 005 minimum 80 power Based on these parameters the total sample size was calculated as 28 participants for each group
This study was conducted as a prospective clinical and radiographic evaluation A total of 76 teeth first and second primary molars from 5- to 9-year-old healthy and cooperative children with nonclinical and radiographic evidence of infection symptoms and with indications for indirect pulp treatment were included in this study The teeth were divided into three groups according to the pulp capping materials
Inclusion and exclusion criteria
Healthy patients aged 5-9 years were recruited from the pediatric dental clinic at Health Sciences University Based on the clinical and radiographic examinations the inclusion criteria were previously untreated first and second primary molars in cooperative children with good general health which had deep dentin caries involving occluso-proximal surfaces but showed positive response to vitality tests electrical pulp test and cold stimulation Endo Ice Hygienic ColteneWhaledent AG Altstatten Switzerland and Diagnostic Unit SybronEndo Orange CA were radiographically detected with caries penetration involving approximately 34 of the dentin thickness were considered to have a potential to result in pulp exposure when the entire caries was cleared according to the complete excavation procedure in which the end point of carious tissue removal is the hard dentin and showed a moderate response to chemical and thermal stimuli Clinical success criteria were as follows signs of irreversible pulpitis such as spontaneous pain prolonged pain response presence of percussion or palpation pathological mobility infectious symptoms such as fistula or abscess and discoloration in the clinical examination Radiographic success criteria included presence of radiolucency in the furcation or periapical regions thickening of the periodontal spaces and internal or external root resorption
Clinical practice
Two pediatric dentists screened each patient for inclusion and exclusion criteria during a preoperative oral examination and participants that met the inclusion criteria were randomly divided into three groups Biodentine group n 25 TheraCal PT group n26 Therabase group n 25
Following the application of topical and local anaesthesia injection 2 lidocaine hydrochloride with epinephrine 180000 Septodont Saint-Maur-des-Fosses France rubber-dam isolation Dental Dam Coltène Whaledent Langenau Germany were performed The tooth was disinfected by scrubbing with 2 chlorhexidine The carious peripheral dentin was removed using a high-speed dental diamond bur Dentsply Dentsply Maillefer Baillaigues Switzerland and the infected and necrotic soft dentin layer in the center was carefully removed to prevent pulp exposure Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation and the demineralized dentin affected dentin was left at the floor of the cavity After removal of carious the cavities were washed with 2 chlorhexidine gluconate irrigation solution Klorhex Drogsan Türkiye and then were dried with an air-water spray and cotton pellets Biodentine TheraCal PT and Therabase materials were applied according to the manufacturers instructions
Biodentine group The entire residual demineralized dentin tissue covered with approximately 1mm tricalcium silicate pulp-capping material Biodentine SeptodontSaint-Maur-des-FossésFrance by avoiding the placement of the material on enamel or margins of the cavity After application of Biodentin 12-min setting time was allowed for setting in accordance with the recommendations of the manufacturer
Theracal PT group The entire residual demineralized dentin tissue covered with maximum thickness of 1mm flowable form of resin-modified calcium silicate-containing material TheraCal PTBisco IncSchaumburgILUSA by avoiding the placement of the material on enamel or margins of the cavity After appllication of TheraCal PT the polymerization for 20s Elipar Deep Cure 3 M ESPE St Paul MN USA in accordance with the recommendations of the manufacturer
Therabase group The entire residual demineralized dentin tissue covered with maximum thickness of 1mm flowable form of dual-cured calcium and fluoride releasing self-adhesive baseliner material Therabase Therabase PTBisco IncSchaumburgILUSA by avoiding the placement of the material on enamel or margins of the cavity After appllication of TheraCal PT the polymerization for 20s Elipar Deep Cure 3 M ESPE St Paul MN USA in accordance with the recommendations of the manufacturer
Afterwards in all three groups glass ionomer cement consisting of powder and liquid Ketac Molar Easy Mix 3M ESPE Germany was placed on each capping material Following the etching and bonding process permanent restoration was finished with composite resin Filtek Z250 Universal Restorative System 3M ESPE DentalProducts USA
Clinical and radiographic examination The patients were called for follow-up at 1 months 6 months and 1 year during the first year At each follow-up visit a clinical examination was performed to assess the presence of tenderness to percussion or palpation spontaneous pain or prolonged pain response discoloration infectious symptoms such as fistula or abscess and pathological mobility Additionally a radiographic examination was performed to assess the presence of lesions in the furcation or periapical regions internal or external root resorption and thickening of the periodontal spaces The teeth detected with at least one of these findings were considered unsuccessful
Statistical analysis All statistical analyses were performed by using software SPSS IBM SPSS Statistics 2022 Normality and homegenity of the data were evaluated by using Kolmogorov-Smirnov and Levenes Homogeneity tests Pearson chi-square and Kruskall-Wallis H tests were performed to analyze data at the 95 confidence level P 005
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