Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol

Sarah Abdelbar Mahmoud

Status and phase: Unknown; Phase 3

Conditions: Caries

Treatments: Drug: Premixed bioceramic MTA; Drug: Formocresol

Study type: Interventional

Funder types: Other

Identifiers

NCT05314842

203

Details and patient eligibility

About

examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

control group

Active Comparator group

Description:

the group that have caries in primary molars and treat them with formocresol

Treatment:

Drug: Formocresol

experimental group

Experimental group

Description:

the group that have caries in primary molars and treat them with premixed bioceramic MTA

Treatment:

Drug: Premixed bioceramic MTA