Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MTA Pulpotomy.
Biodentine Pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success
Eligibility Criteria
Inclusion Criteria:
- Patients aging between 18-40 years old
- Patients with symptomatic irreversible pulpitis.
- Radiographically: Absence or slight widening in periodontal ligament space.
- Systemically- healthy patients (ASA I or II).
- Patients who agree to attend for recall appointments and provide written consent.
Exclusion Criteria:
- Severe marginal periodontitis.
- Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.
- Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mineral Trioxide Aggregate (MTA)
Biodentine
Arm Description
Outcomes
Primary Outcome Measures
Postoperative pain after 6 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.
0 reading represents "no pain"
1- 3 readings represent "mild pain"
4- 6 readings represent "moderate pain"
7- 10 readings represent "severe pain"
Postoperative pain after 12 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.
0 reading represents "no pain"
1- 3 readings represent "mild pain"
4- 6 readings represent "moderate pain"
7- 10 readings represent "severe pain"
Postoperative pain after 24 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.
0 reading represents "no pain"
1- 3 readings represent "mild pain"
4- 6 readings represent "moderate pain"
7- 10 readings represent "severe pain"
Secondary Outcome Measures
Overall (clinical and radiographic) success after 6 months postoperatively.
Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.
Overall (clinical and radiographic) success after 12 months postoperatively.
Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03890835
Brief Title
Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA
Official Title
Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.
Detailed Description
Patients will be clinically and radiographically examined and their eligibility will be assessed.
Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA).
After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA
The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken.
The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times.
The patients will be recalled after 6 and 12 months post-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Masking
Participant
Masking Description
The study will be participant-blind where the participant will not know the intervention done.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mineral Trioxide Aggregate (MTA)
Arm Type
Active Comparator
Arm Title
Biodentine
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MTA Pulpotomy.
Intervention Description
Pulpotomy using MTA.
Intervention Type
Procedure
Intervention Name(s)
Biodentine Pulpotomy
Intervention Description
Pulpotomy using Biodentine
Primary Outcome Measure Information:
Title
Postoperative pain after 6 hours postoperatively
Description
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.
0 reading represents "no pain"
1- 3 readings represent "mild pain"
4- 6 readings represent "moderate pain"
7- 10 readings represent "severe pain"
Time Frame
6 hours postoperatively
Title
Postoperative pain after 12 hours postoperatively
Description
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.
0 reading represents "no pain"
1- 3 readings represent "mild pain"
4- 6 readings represent "moderate pain"
7- 10 readings represent "severe pain"
Time Frame
12 hours postoperatively
Title
Postoperative pain after 24 hours postoperatively
Description
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.
0 reading represents "no pain"
1- 3 readings represent "mild pain"
4- 6 readings represent "moderate pain"
7- 10 readings represent "severe pain"
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Overall (clinical and radiographic) success after 6 months postoperatively.
Description
Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.
Time Frame
6 months postoperatively
Title
Overall (clinical and radiographic) success after 12 months postoperatively.
Description
Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.
Time Frame
12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aging between 18-40 years old
Patients with symptomatic irreversible pulpitis.
Radiographically: Absence or slight widening in periodontal ligament space.
Systemically- healthy patients (ASA I or II).
Patients who agree to attend for recall appointments and provide written consent.
Exclusion Criteria:
Severe marginal periodontitis.
Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.
Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youssef A. Kamal Elalfy, B.D.S
Phone
+201286069484
Email
Youssef_Andraws@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan AW Amin, Ph.D.
Email
swaness@rocketmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youssef A. Kamal Elalfy, B.D.S.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24771228
Citation
Asgary S, Eghbal MJ, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27.
Results Reference
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PubMed Identifier
29061359
Citation
Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
Results Reference
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PubMed Identifier
28822566
Citation
Bakhtiar H, Nekoofar MH, Aminishakib P, Abedi F, Naghi Moosavi F, Esnaashari E, Azizi A, Esmailian S, Ellini MR, Mesgarzadeh V, Sezavar M, About I. Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial. J Endod. 2017 Nov;43(11):1786-1791. doi: 10.1016/j.joen.2017.06.025. Epub 2017 Aug 16.
Results Reference
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Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA
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