Vital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material

Study Overview
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Brief Summary
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This clinical trial is designed to study and compare the effect of two different types of chelating agents on the vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.

Detailed Description
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The vital pulps exposed by caries process is treated by complete caries removal followed by full pulpotomy. After hemostasis, application of apple vinegar and EDTA 17% will be used followed by MTA application. finally teeth will be restored with resin composite restoration.

Official Title
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The Effect of Two Different Contemporary Chelating Agents on Vital Pulp Therapy in Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material

Conditions
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Vital Pulp Therapy

Intervention / Treatment
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* Other: Apple vinegar or EDTA 17%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of at least one tooth with carious pulp exposure and irreversible pulpitis. Cooperative behavior with no medical problem. Absence of tooth mobility , tenderness on percussion. History of pain with cold and sweets. Radiographically, no internal or external resorption, no periapical or furcation radiolucency and no widening of the periodontal membrane space. Exclusion Criteria: Teeth with pulp necrosis. Presence of sinus tract. Teeth with open apices. Pregnant women. History of intolerance of non- steroidal anti inflammatory drugs. Tenderness to palpation of adjacent soft tissues

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel double blinded.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple vinegar group<br>After hemostasis of the exposed pulp is achieved, Apple vinegar will be used for dentin conditioning for 5 mins then 1-2 mm thickness of MTA placed on the exposed pulp chamber. | Other: Apple vinegar or EDTA 17%<br>* Application of each chelating agent for 5 minutes for dentin conditioning followed by placement of MTA on the pulp chamber.<br>|
| Active Comparator: EDTA 17% group<br>After hemostasis of the exposed pulp is achieved, EDTA 17 % will be used for dentin conditioning then 1-2 mm thickness of MTA placed on the exposed pulp chamber. | Other: Apple vinegar or EDTA 17%<br>* Application of each chelating agent for 5 minutes for dentin conditioning followed by placement of MTA on the pulp chamber.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material. | Through post operative pain assessment using Visual analogue scale (0-3) scores as 0 represents no pain, 1= mild pain, 2= moderate pain and 3= sever pain. VAS scores marked at intervals of 2,6,24,48 and 72 hours. Clinical success criteria: Clinical parameters indicating successful treatment include the following criteria: Absence of pain except for the first 24 hours. Normal soft tissue around the tooth ( no swelling, no sinus tract). | one year | 
| The Pulp vitality | Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic success | Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include: No periapical pathosis. No radicular resorption defects. | one year |