Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols

Pulp Necroses Clinical Trial

Official title:

Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181813
• Other study ID #: 06030718
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Infected Pulp
• Necrosis
• Primary Teeth
• Pulp Necroses
• Root Canal Treatment

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