Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure (PULPOTOMY)
September 15, 2021 updated by: Jordan University of Science and Technology
Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.
The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.
Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.
Study Type
Interventional
Enrollment (Actual)
109
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 Locations
-
-
-
Irbid, Jordan, 22110
- Jordan University of Science and Technology
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-
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
7 years to 80 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Permanent teeth with mature or immature apices
- Have no significant medical problems
- The tooth should give positive response to cold test and electric pulp test (EPT)
- Probing pocket depth and mobility within normal limits
- No Signs of pulp necrosis including sinus tract or swelling
- Radiographically ; caries either exposing the pulps or reaching more than 2\3 the distance from the dentino-enamel junction (DEJ) to the pulp
- The tooth can be restored via direct restoration
Exclusion Criteria:
- Medically compromised patients
- Negative response to cold test
- Mobility
- Sinus tract
- Swelling
- Non restorable teeth or badly broken teeth
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Patients with carious teeth
female or male patients with permanent teeth and deep caries will receive pulpotomy treatment and dressing with calcium silicate based material (Neo MTA plus material) followed by restoration.
|
Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain symptoms
Time Frame: 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.
|
The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments.
The patient will be asked to score the pain level on visual analogue scale using a score from 0-10.
The zero is no pain while 10 is the maximum level.
|
2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Periapical normalcy at follow up radiographs .
Time Frame: 6months , 1 year, 2, 3,4,5 years
|
Pr-existing pathology should heal within 6 months- 1 year and normalcy should be maintained after ward up to 5 years. no emerging pathosis should be evident in the roots or surrounding bone. |
6months , 1 year, 2, 3,4,5 years
|
|
The tooth and restoration should be present in the mouth
Time Frame: 3, 6 months, 1 year, 2, 3,4,5 years
|
The tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times
|
3, 6 months, 1 year, 2, 3,4,5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Nessrin A Taha, PhD, Jordan University of Science and Technology
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
- Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.
- Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.
- Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.
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 (ACTUAL)
December 1, 2016
Primary Completion (ACTUAL)
June 1, 2019
Study Completion (ACTUAL)
August 20, 2021
Study Registration Dates
First Submitted
April 19, 2018
First Submitted That Met QC Criteria
April 29, 2018
First Posted (ACTUAL)
May 11, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 15, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JUST14-4-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Baseline demographic data and follow-up results may be shared after manuscript acceptance by international journals
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.