Caries
Conditions
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.
Interventions
DRUGFormocresol
dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars
DRUGPremixed bioceramic MTA
dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars
Sponsors
Sarah Abdelbar Mahmoud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft-tissue pathology | at 0 day | * 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
| Measure | Time frame | Description |
|---|---|---|
| • Pain to the percussion | at 0 day | will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent) |
| mobility | at 0 day | • Mobility is scored on a scale of 1-3 as follows: 1. the movement that is greater than normal (physiological) movement. 2. a maximum of 1 mm in the buccolingual direction. 3. depreciable buccolingual movement of more than 1 mm. Miller's Grades |
| radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). | at 0 day | Binary (present or absent) |
Contacts
Primary Contactsarah A Mahmoud, B.D.S
Backup ContactmaiI A Mahmed, PHD
Outcome results
None listed