New Vital Pulpotomy Medications in Primary Molars

Study Overview
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Brief Summary
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Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.

Detailed Description
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Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for: Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods. Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.

Official Title
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Clinical and Radiographic Evaluation of Hyaluronic Acid and Biodentine as Vital Pulpotomy Medications in Primary Molars: Randomized Controlled Clinical Trial

Conditions
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Carious Exposure of Pulp

Intervention / Treatment
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* Drug: Formocresol
* Drug: Biodentine
* Drug: Hyaluronic acid gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Clinical criteria Restorable mandibular primary molars with deep carious lesions. Absence of gingival swelling or sinus tract. Absence of spontaneous pain Absence of pain on percussion. B-Radiographic Criteria: Absence of Discontinuity of lamina dura Internal root resorption. External root resorption. inter-radicular or periapical bone destruction (radiolucency) Exclusion Criteria: Excessive bleeding during pulp amputation. Non vital/necrotic teeth. Any sort of medical history contraindicating the pulp treatment. Teeth approximate exfoliation Patient's guardians are not intending to be part of the study. Retreatment of previously pulpotomy treated molar -

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 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: control: Formocresol<br>Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste. | Drug: Formocresol<br>* Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute<br>|
| Experimental: Group A : (Biodentine)<br>The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set. | Drug: Biodentine<br>* Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps<br>|
| Experimental: Group B : (Hyaluronic acid gel)<br>Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste. | Drug: Hyaluronic acid gel<br>* Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinically successful pulpotomy | Pain symptom - free teeth on percussion as well as during mastication. Absence of pathological tooth mobility. Absence of swelling of pulpal origin. . Absence of sinus tract. | 18 months | 
| radiographically successful pulpotomy | No internal or external root resorption. No periapical or furcation radiolucency. No widening of periodontal ligament space. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid - Biodentine - Pulpotomy