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NCT04397094 Clinical Trial

Theracal Pulpotomy in Primary Molars

Deep Caries Clinical Trial

Official title:
Theracal Versus Formocresol Pulpotomy in Primary Molars

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04397094
Other study ID # FDASU-Rec ID 101612
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2017
Est. completion date March 30, 2019

Study information
Verified date July 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 30, 2019
Est. primary completion date March 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 7 Years
Eligibility Inclusion Criteria:

- healthy, cooperative children

- mandibular primary molars with vital pulp exposures

Exclusion Criteria:

- clinical or radiographic evidence of irreversible pulpitis

- physiological root resorption

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Theracal LC
pulpotomy
• Formocresol
Pulpotomy

Locations
Country Name City State
Egypt Faculty of Dentistry, Ain Shams University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Examination Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion. 12 months
Secondary Radiographic Examination Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space. 12 months
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