Clinical and Radiographic Evaluation of Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol Among a Group of Egyptian Children: A Pilot Study.
Overview
- Phase
- Phase 3
- Intervention
- Formocresol
- Conditions
- Caries
- Sponsor
- Sarah Abdelbar Mahmoud
- Enrollment
- 40
- Primary Endpoint
- Soft-tissue pathology
- Last Updated
- 4 years ago
Overview
Brief Summary
examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.
Detailed Description
Primary outcome: Soft-tissue pathology * Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. * Sinus tract or fistula will be assessed through visual examination by the operator Secondary outcomes: 1. Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror 2. mobility will be assessed through the back of two mirrors 3. radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period. • These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline.
Investigators
Sarah Abdelbar Mahmoud
principal investigator
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Medically fit and cooperative children.
- •Pediatric patients aged 4-6 years.
- •A deep carious lesion in vital primary molars.
- •Absence of clinical signs and symptoms of pulpal exposure.
- •Absence of radiographic signs and symptoms of people degeneration.
- •Positive parental informed consent.
Exclusion Criteria
- •Uncooperative children.
- •Medically compromised children.
- •Presence of clinical signs and symptoms of pulpal exposure.
- •Presence of radiographic signs and symptoms of pulp degeneration.
- •Physiologic root resorption more than one-third.
Arms & Interventions
control group
the group that have caries in primary molars and treat them with formocresol
Intervention: Formocresol
experimental group
the group that have caries in primary molars and treat them with premixed bioceramic MTA
Intervention: Premixed bioceramic MTA
Outcomes
Primary Outcomes
Soft-tissue pathology
Time Frame: at 1 year
Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. -Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)
Secondary Outcomes
- mobility(at 1 year)
- radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).(at 1 year)
- • Pain to the percussion(at 1 year)