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

Not Applicable

Completed

• Conditions: Infected Pulp; Root Canal Treatment; Pulp Necroses; Primary Teeth
• Interventions: Procedure: Ginge-Cal; Procedure: Metapex

• Registration Number: NCT05181813
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-10-17
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-06
• Primary Completion: 2022-04-30
• Study Completion: 2022-08-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

All that does not correspond to inclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Ginge-Cal group:	Ginge-Cal	primary molars were filled by creamy mixture pulpectomy paste of Gingerols and Calcium Hydroxide.
Group 2: Metapex group	Metapex	primary molars were filled by a ready-made injectable creamy mixture pulpectomy paste of Metapex

Primary Outcome Measures

Name	Time	Method
Percentage of primary teeth with control necrotic pulp by radiographic examination	Up to 18 months	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
Percentage of primary teeth with control necrotic pulp by clinical examination	Up to 18 months	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.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Mansoura, Dakahlia, Egypt