Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars

Study Overview
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Brief Summary
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The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.

Detailed Description
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The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.

Official Title
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Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars: An Equivalent Parallel Randomized Controlled Trial

Conditions
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Direct Pulp Capping

Intervention / Treatment
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* Other: direct pulp capping in primary molars


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Clinical: Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale. Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS). Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic: Presence of at least two-thirds of root length. Normal lamina dura and periodontal ligament space. Exclusion Criteria: 1. Clinical: History of spontaneous unprovoked toothache. Extensive crown destruction that preclude coronal restoration. Gingival swelling, sinus tract or other soft tissue pathology. Abnormal tooth mobility. A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy. No evidence of visible pulp exposure. 2. Radiographic: Furcation/periapical radiolucency. Pathological internal/external root resorption. Absence of underlying permanent successor

Ages Eligible for Study
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Minimum Age: 4 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 I (control): Calcium hydroxide cement<br>Pulp capping material | Other: direct pulp capping in primary molars<br>* caries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp.<br>|
| Active Comparator: Group 2: Premixed bioceramic putty<br>Pulp capping material | Other: direct pulp capping in primary molars<br>* caries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical findings | The children will be recalled for postoperative clinical & radiographic assessments at the following intervals; six, twelve, eighteen,and twenty-four 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. | 2 year follow up |