- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573374
Comparing the Outcome of Pulpotomy Using Biodentine and Portland Cement in Mature Cases With Irreversible Pulpitis: Randomized Clinical Trial
September 30, 2020 updated by: Aya Ahmed Youssef, Cairo University
The aim of the study is to compare the treatment outcome of pulpotomy using Biodentine or Portland cement regarding success rate and post-operative pain.
Study Overview
Detailed Description
- Patients will be screened for eligibility through obtaining medical and dental histories together with clinical [visual, palpation, percussion, cold sensitivity testing and probing] and radiographic evaluations for the teeth.
- After ensuring eligibilty, profound local anesthesia of the tooth will be achieved using 4% Articaine with 1: 100000 epinephrine (Septodont. Saint-Maur-des-Fosses. France).
- Caries will be removed using a round, high-speed bur with adequate water cooling.
- Cases will be randomly divided into two groups according to pulpotomy material either: Biodentine or Portland cement. Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. Initial setting is achieved after 12 minutes. Preparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio. The mix is sieved through silk sieve then sterilized in hot air oven at 135 ֯C for 2 hours. Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet. A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed.
- Appropriate interim restoration will be done and checked throughout follow up period. Patients will be referred for final restoration after endpoint of research. A post-operative periapical radiograph is taken after interim restoration placement.
- Patients will be contacted by telephone by the same operator to record pain intensity (at 6, 12, 24, 48 and after 7 days).
- Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
Study Type
Interventional
Enrollment (Anticipated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aya A Gamal, MSc
- Phone Number: 01111078317
- Email: aya.youssef@dentistry.cu.edu.eg
Study Contact Backup
- Name: Ghada Eid, phD
- Email: ghada.eid@dentistry.cu.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Exposed permanent teeth with mature roots.
- Asymptomatic irreversible pulpitis (no or mild symptoms) and Symptomatic irreversible pulpitis {spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (interpreted as lingering pain)} compared to contralateral normal teeth, and which could be reproduced using cold testing.
- Pre-operative pain assessed as none (but clinically exposed), moderate or severe on Numerical Rating Scale (NRS).
- The tooth is restorable and free from advanced periodontal disease.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
- Vital bleeding pulp tissue should be present in all canals after pulpotomy.
- Age: more than 18 years
Exclusion Criteria:
- Immature teeth.
- Necrotic pulp and absence of bleeding upon exposure.
- Teeth unresponsive to cold stimulation, presence of sinus tracts or swelling, presence of periapical rarefaction, internal or external root resorption or root canal calcification on radiograph.
- Non-restorable teeth or teeth indicated for post and core restoration
- Teeth with severe periodontal disease.
- Any serious medical problem that prevented the patient from receiving treatment or attending follow-up visits. Pregnant or lactating female patients.
- Patients who used long-acting Non-steroidal anti-inflammatory drugs (NSAIDs) before treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Biodentine
Biodentine (BD; Septodont, St Maur-des-Fosses, France) is a calcium silicate capping material.
Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser.
Initial setting is achieved after 12 minutes.
|
Pulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue.
Other Names:
|
Active Comparator: Portland cement
Preparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio.
The mix is sieved through silk sieve then sterilized in hot air oven at 135 ֯C for 2 hours.
Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet.
A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed
|
Pulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulpotomy Success rate
Time Frame: 3 months
|
Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria.
Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth.
Soft tissues around the tooth are normal with no swelling or sinus tract.
Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction.
In case of failure, the tooth will be treated endodontically and referred for final restoration.
|
3 months
|
Pulpotomy success rate
Time Frame: 6 months
|
Clinical and radiographic evaluation is scheduled at 6 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria.
Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth.
Soft tissues around the tooth are normal with no swelling or sinus tract.
Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction.
In case of failure, the tooth will be treated endodontically and referred for final restoration.
|
6 months
|
Pulpotomy success rate
Time Frame: 12 months
|
Clinical and radiographic evaluation is scheduled at 12 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria.
Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth.
Soft tissues around the tooth are normal with no swelling or sinus tract.
Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction.
In case of failure, the tooth will be treated endodontically and referred for final restoration.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain
Time Frame: 6, 12, 24, 48 hours and 1 week
|
Patients will be contacted by telephone by the same operator to record pain intensity on Numerical Rating Scale (NRS)
|
6, 12, 24, 48 hours and 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aya A Gamal, MSc, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
- Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.
- Danesh G, Dammaschke T, Gerth HU, Zandbiglari T, Schafer E. A comparative study of selected properties of ProRoot mineral trioxide aggregate and two Portland cements. Int Endod J. 2006 Mar;39(3):213-9. doi: 10.1111/j.1365-2591.2006.01076.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2020
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
September 27, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
September 30, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2020-09-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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