Carious Exposure of Pulp
Conditions
Keywords
Hyaluronic Acid - Biodentine - Pulpotomy
Brief summary
Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.
Detailed description
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.
Interventions
DRUGFormocresol
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
DRUGBiodentine
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
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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
the observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinically successful pulpotomy | 18 months | 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. |
| radiographically successful pulpotomy | 18 months | 1. No internal or external root resorption. 2. No periapical or furcation radiolucency. 3. No widening of periodontal ligament space. |
Countries
Egypt
Outcome results
None listed