Theracal Pulpotomy in Primary Molars

Phase 4

Completed

• Conditions: Deep Caries
• Interventions: Drug: Formocresol; Drug: Theracal LC

• Registration Number: NCT04397094
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-03-17
• Study Completion: 2019-03-30
• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-05-17
• Study First Posted: 2020-05-21
• Results First Submitted: 2020-06-21
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-11
• Last Update Submitted: 2020-07-11
• Results First Posted: 2020-07-29
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

• clinical or radiographic evidence of irreversible pulpitis
• physiological root resorption

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formocresol	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.
Theracal LC	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.

Primary Outcome Measures

Name	Time	Method
Clinical Examination	12 months	Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.

Secondary Outcome Measures

Name	Time	Method
Radiographic Examination	12 months	Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space.

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt