Symptomatic Irreversible PulpitisNCT03890835
Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA
A study testing MTA Pulpotomy. and Biodentine Pulpotomy in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- MTA Pulpotomy. and Biodentine Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Suzan AW Amin, Ph.D. contact
About this study
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
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.
Read the 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.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- MTA Pulpotomy., Biodentine Pulpotomy
- Keywords
- Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA Pulpotomy.Procedure or surgery
Pulpotomy using MTA.
Biodentine PulpotomyProcedure or surgery
Pulpotomy using Biodentine
| Study group | Role | What they receive |
|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Active comparator | Not described Receives: Procedure: MTA Pulpotomy. |
| Biodentine | Experimental | Not described Receives: Procedure: Biodentine Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 6 hours postoperatively
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"
Measured: 12 hours postoperatively
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"
Measured: 24 hours postoperatively
Secondary outcomes (2)
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.
Measured: 6 months postoperatively
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.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Andraws, Cairo University
- Investigators
- Youssef A. Kamal Elalfy, B.D.S., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890835
- Sponsor's protocol ID
- CEBD-CU-2019-03-10
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24771228Galani 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.
PubMed 29061359Bakhtiar 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.
PubMed 28822566
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03890835
- Acronym / sponsor ID
- CEBD-CU-2019-03-10
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
| Arm | Type | Receives |
|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Active comparator | Procedure: MTA Pulpotomy. |
| Biodentine | Experimental | Procedure: Biodentine Pulpotomy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTA Pulpotomy.Pulpotomy using MTA. | Procedure or surgery | Mineral Trioxide Aggregate (MTA) |
| Biodentine PulpotomyPulpotomy using Biodentine | Procedure or surgery | Biodentine |
Primary outcome
Postoperative pain after 6 hours postoperatively
Time frame: 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
Time frame: 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
Time frame: 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"
2 secondary outcomes
Overall (clinical and radiographic) success after 6 months postoperatively.
Time frame: 6 months postoperatively
Overall (clinical and radiographic) success after 12 months postoperatively.
Time frame: 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 24771228Asgary 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.
- Background: PubMed 29061359Galani 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.
- Background: PubMed 28822566Bakhtiar 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.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Irreversible Pulpitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzan AW Amin, Ph.D. contact
Youssef A. Kamal Elalfy, B.D.S. principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing MTA Pulpotomy. and Biodentine Pulpotomy in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youssef A. Kamal Elalfy, B.D.S (+201286069484, Youssef_Andraws@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain after 6 hours postoperatively (time frame: 6 hours postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890835, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.