Theracal Pulpotomy in Primary Molars

NCT ID: NCT04397094

Last Updated: 2020-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-03-30

Brief Summary

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Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

Detailed Description

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sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.

Conditions

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Deep Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Theracal LC

Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.

Group Type EXPERIMENTAL

Theracal LC

Intervention Type DRUG

pulpotomy

Formocresol

Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.

Group Type ACTIVE_COMPARATOR

Formocresol

Intervention Type DRUG

Pulpotomy

Interventions

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Theracal LC

pulpotomy

Intervention Type DRUG

Formocresol

Pulpotomy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy, cooperative children
* mandibular primary molars with vital pulp exposures

Exclusion Criteria

* clinical or radiographic evidence of irreversible pulpitis
* physiological root resorption
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mariem Wassel

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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FDASU-Rec ID 101612

Identifier Type: -

Identifier Source: org_study_id

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