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

Phase 3

• Conditions: Caries
• Interventions: Drug: Premixed bioceramic MTA; Drug: Formocresol

• Registration Number: NCT05314842
• Lead Sponsor: Sarah Abdelbar Mahmoud

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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-25
• Study Start: 2022-04-01
• Study First Submitted QC: 2022-04-02
• Last Update Submitted: 2022-04-02
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Primary Completion: 2023-04-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Premixed bioceramic MTA	the group that have caries in primary molars and treat them with premixed bioceramic MTA
control group	Formocresol	the group that have caries in primary molars and treat them with formocresol

Primary Outcome Measures

Name	Time	Method
Soft-tissue pathology	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 Outcome Measures

Name	Time	Method
mobility	at 1 year	• 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 1 year	Binary (present or absent)
• Pain to the percussion	at 1 year	will be assessed by gentle tapping on the tooth with the end of a dental mirror.; Binary (present or absent)