Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries

Study Overview
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Brief Summary
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The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.

Detailed Description
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Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial

Official Title
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Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial

Conditions
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Indirect Pulp Capping, Pulpotomy

Intervention / Treatment
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* Combination Product: MTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 4 to 6 years old patients presented with deep carious lesions in primary molars. Apparently healthy children (ASA I, II classification). Co-operative children (Rating 3 & 4 according to Frankle classification) Exclusion Criteria: A) Clinical: Non restorable primary molars. Presence of clinical pathology. Presence of mobility or tenderness to percussion. Spontaneous pain. B) Radiographic: Pre-operative radiographs showed external or internal root resorption. Presence of furcal radiolucency. Presence of periapical radiolucency or widened periodontal ligament space More than one-third root resorption detected.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Indirect pulp capping with MTA | Combination Product: MTA<br>* Mineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.<br>|
| Active Comparator: Group 2<br>Pulpotomy with MTA | Combination Product: MTA<br>* Mineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiographic evaluation | The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: pain tenderness to palpation or percussion gingival swelling or sinus tract purulent exudate expressed from the gingival margin abnormal tooth mobility Radiographic criteria: periapical radiolucency widening in peridontal ligament space | 2 years follow up |