Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

Study Overview
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Brief Summary
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The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

Official Title
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Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study

Conditions
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Clinical Evaluation Including Pain and Swelling

Intervention / Treatment
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* Drug: Novel fast-setting calcium silicate cement (Protooth)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs No allergic reactions recorded in patient history Having primary molar teeth in one jaw, having deep caries and vital pulp. No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test Radiographic criteria: No sign of radiolucency in periapical or furcation area No widening of PDL space or loss of lamina dura continuity No evidence of internal/external pathologic root resorption Exclusion Criteria: Lack of informed consent by the child patient's parent Lack of informed consent by the child patient's parent Unable to attend follow-up visits. Refusal of participation.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 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: Novel fast setting calcium silicate ( Protooth)<br>In the form of powder and liquid to be mixed together to form paste. | Drug: Novel fast-setting calcium silicate cement (Protooth)<br>* In form of power and liquid to be mixed together to form a paste.<br>* Other names: mineral trioxide aggregate (MTA );|
| Experimental: MTA<br>In form of powder to be mixed with saline to form paste. | Drug: Novel fast-setting calcium silicate cement (Protooth)<br>* In form of power and liquid to be mixed together to form a paste.<br>* Other names: mineral trioxide aggregate (MTA );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS | Post-operative pain following pulpotomy treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes No pain and the worst pain. Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, no pain 1-3, mild pain 4-6, moderate pain 7-10, severe pain Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation following the Pulpotomy treatment will be measured | Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpotomy , Primary molars , Protooth , MTA