Clinical trial
Clinical and Radiographic Evaluation of Hyaluronic Acid and Biodentine as Vital Pulpotomy Medications in Primary Molars: Randomized Controlled Clinical Trial
Name
A0103023PP
Description
Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.
Trial arms
Trial start
2023-05-01
Estimated PCD
2024-11-01
Trial end
2024-11-01
Status
Active (not recruiting)
Treatment
Formocresol
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
Arms:
control: Formocresol
Biodentine
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
Arms:
Group A : (Biodentine)
Hyaluronic acid gel
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.
Arms:
Group B : (Hyaluronic acid gel)
Size
48
Primary endpoint
clinically successful pulpotomy
18 months
radiographically successful pulpotomy
18 months
Eligibility criteria
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 -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'the observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-07-10
1 organization
Organization
Mansoura University