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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05181813
Other study ID # 06030718
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 17, 2020
Est. completion date August 30, 2022

Study information

Verified date January 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp


Description:

Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 8 Years
Eligibility Inclusion Criteria: 1. The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments. 2. Parents signed the consent to participate in the study. 3. Absence of any systemic disease, which would contraindicate pulp therapy. 4. Child didn't have any history of a sensitive reaction to any component of used materials. 5. Present half to two third of tooth root or more 6. Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment. Exclusion Criteria: All that does not correspond to inclusion criteria.

Study Design


Intervention

Procedure:
Ginge-Cal
Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal)
Metapex
Fill the infected root canal of of primary teeth with Metapex

Locations

Country Name City State
Egypt Faculty of Dentistry Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of primary teeth with control necrotic pulp by clinical examination The primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age. Up to 18 months
Primary Percentage of primary teeth with control necrotic pulp by radiographic examination The primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption Up to 18 months
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