Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure

Conditions
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Pulpotomy

Intervention / Treatment
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* Other: calcium silicate based material,


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with symptomatic deep caries in a permanent molar tooth will receive pulpotomy treatment and placement of a calcium silicate based material (Neo MTA plus) over the pulp and followed by restoration.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with carious teeth<br>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. | Other: calcium silicate based material,<br>* Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation<br>* Other names: Neo MTA plus, Avalon Biomed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain symptoms | 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 . | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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teeth, pulpitis, deep caries, pulpotomy, Mineral Trioxide Aggregate (MTA)