New Vital Pulpotomy Medications in Primary Molars

N/AActive Not RecruitingNCT05937100

Mansoura University48 enrolled

Overview

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

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: 1. Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods. 2. Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Carious Exposure of Pulp

Interventions

FormocresolDRUG

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

BiodentineDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * -Clinical criteria 1. Restorable mandibular primary molars with deep carious lesions. 2. Absence of gingival swelling or sinus tract. 3. Absence of spontaneous pain 4. Absence of pain on percussion. B-Radiographic Criteria: Absence of  1. Discontinuity of lamina dura 2. Internal root resorption. 3. External root resorption. 4. inter-radicular or periapical bone destruction (radiolucency) Exclusion Criteria: 1. Excessive bleeding during pulp amputation. 2. Non vital/necrotic teeth. 3. Any sort of medical history contraindicating the pulp treatment. 4. Teeth approximate exfoliation 5. Patient's guardians are not intending to be part of the study. 6. Retreatment of previously pulpotomy treated molar -

Locations (1)

Dentistry

Al Mansurah, Egypt

Outcomes

Primary Outcomes

clinically successful pulpotomy

1. Pain symptom - free teeth on percussion as well as during mastication. 2. Absence of pathological tooth mobility. 3. Absence of swelling of pulpal origin. 4. . Absence of sinus tract.

Time frame: 18 months

radiographically successful pulpotomy

1. No internal or external root resorption. 2. No periapical or furcation radiolucency. 3. No widening of periodontal ligament space.

Time frame: 18 months

Data from ClinicalTrials.gov

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