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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

Formocresol

Intervention Type DRUG

dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars

experimental group

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

Group Type EXPERIMENTAL

Premixed bioceramic MTA

Intervention Type DRUG

dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars

Interventions

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Formocresol

dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars

Intervention Type DRUG

Premixed bioceramic MTA

dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars

Intervention Type DRUG

Other Intervention Names

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Neoputty

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes