Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04265833
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2019-12-26
Brief Title:
Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth
Sponsor:
Izmir Katip Celebi University
Organization:
Izmir Katip Celebi University
Study Overview
Official Title:
Clinical Radiographic and Histological Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-02
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 aim of this randomized controlled three-arm parallel-group double-blinded clinical trial was to evaluate the clinical radiographic and histopathological success of three different pulp-capping materials in one-stage indirect pulp treatment of primary teeth
The study included a total of 109 patients aged 5-9 years who had primary teeth with deep carious lesions with or symptoms of irreversible pulpitis The teeth were divided into three groups according to the pulp-capping agents I Calcium hydroxide CaOH2 control group n36 II bioactive tricalcium silicate Biodentine n37 and III resin-based tricalcium silicate TheraCal LC n36 All the teeth were evaluated clinically and radiographically at postoperative months 6 12 18 and 24 A total of 23 primary mandibular second molars that were in their regular exfoliation period 24-40 months were extracted and fixed in 10 formaldehyde solution The specimens were evaluated histologically to assess the integrity of the odontoblastic layer tertiary dentin formation and the quality of the dentin formed severity of pulpitis and other pulpal changes
The study included a total of 109 patients aged 5-9 years who had primary teeth with deep carious lesions with or symptoms of irreversible pulpitis The teeth were divided into three groups according to the pulp-capping agents I Calcium hydroxide CaOH2 control group n36 II bioactive tricalcium silicate Biodentine n37 and III resin-based tricalcium silicate TheraCal LC n36 All the teeth were evaluated clinically and radiographically at postoperative months 6 12 18 and 24 A total of 23 primary mandibular second molars that were in their regular exfoliation period 24-40 months were extracted and fixed in 10 formaldehyde solution The specimens were evaluated histologically to assess the integrity of the odontoblastic layer tertiary dentin formation and the quality of the dentin formed severity of pulpitis and other pulpal changes
Detailed Description:
Following the clinical and radiographic examinations pulp vitality was assessed with cold thermal test Chloraethyl Wehr Baden Germany and electrical pulp test After local anesthesia injection rubber-dam isolation was performed In the first step of the IPC procedure cavity preparation was performed and the caries were removed using a high-speed dental handpiece with a diamond bur In the second step the carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide bur 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 this stage the teeth were randomly divided into 3 groups
CaOH2 Group Control The residual demineralized dentin was covered with a thin layer of CaOH2 Dycal DentsplyCaulk Dentsply International Inc Milford DE USA in accordance with the recommendations of the manufacturer
Biodentine Group A thin layer of tricalcium silicate-containing pulp-capping material Biodentine Septodont France consisting of powder and liquid was applied to the demineralized dentin tissue and a 12-min setting time was allowed for hardening in accordance with the recommendations of the manufacturer
TheraCal LC Group Flowable form of resin-reinforced tricalcium silicate-containing material TheraCal LC Bisco Inc IL ABD was applied directly onto the demineralized dentin at a maximum thickness of 1 mm and was polymerized for 20 sec Valo LED Ultradent Products Inc South Jordan USA in accordance with the recommendations of the manufacturer
Afterwards in all three groups capsule glass ionomer cement Capsule GC Corporation Tokyo Japan Corporation Tokyo Japan 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 Dental products USA
Histological examination A total of 23 primary mandibular second molars that were in their regular exfoliation period in which the underlying permanent tooth germ had completed 23 of root formation 24 and were found to be clinically and radiographically successful following IPC were extracted by the researcher and were processed for histological examination All the extracted teeth were fixed in 10 formaldehyde solution Three out of 23 specimens were excluded from the study since they were unsuitable for sectioning
After this stage the teeth were randomly divided into 3 groups
CaOH2 Group Control The residual demineralized dentin was covered with a thin layer of CaOH2 Dycal DentsplyCaulk Dentsply International Inc Milford DE USA in accordance with the recommendations of the manufacturer
Biodentine Group A thin layer of tricalcium silicate-containing pulp-capping material Biodentine Septodont France consisting of powder and liquid was applied to the demineralized dentin tissue and a 12-min setting time was allowed for hardening in accordance with the recommendations of the manufacturer
TheraCal LC Group Flowable form of resin-reinforced tricalcium silicate-containing material TheraCal LC Bisco Inc IL ABD was applied directly onto the demineralized dentin at a maximum thickness of 1 mm and was polymerized for 20 sec Valo LED Ultradent Products Inc South Jordan USA in accordance with the recommendations of the manufacturer
Afterwards in all three groups capsule glass ionomer cement Capsule GC Corporation Tokyo Japan Corporation Tokyo Japan 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 Dental products USA
Histological examination A total of 23 primary mandibular second molars that were in their regular exfoliation period in which the underlying permanent tooth germ had completed 23 of root formation 24 and were found to be clinically and radiographically successful following IPC were extracted by the researcher and were processed for histological examination All the extracted teeth were fixed in 10 formaldehyde solution Three out of 23 specimens were excluded from the study since they were unsuitable for sectioning
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