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

NCT ID: NCT05181813

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-17

Study Completion Date

2022-08-30

Brief Summary

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

Detailed Description

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

Conditions

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Primary Teeth Pulp Necroses Infected Pulp Root Canal Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Selected children will be divided randomly into 2 groups:

Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide.

Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Ginge-Cal group:

primary molars were filled by creamy mixture pulpectomy paste of Gingerols and Calcium Hydroxide.

Group Type EXPERIMENTAL

Ginge-Cal

Intervention Type PROCEDURE

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

Group 2: Metapex group

primary molars were filled by a ready-made injectable creamy mixture pulpectomy paste of Metapex

Group Type ACTIVE_COMPARATOR

Metapex

Intervention Type PROCEDURE

Fill the infected root canal of of primary teeth with Metapex

Interventions

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Ginge-Cal

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

Intervention Type PROCEDURE

Metapex

Fill the infected root canal of of primary teeth with Metapex

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Fathi Abdulraqeb Qasem

PhD in Pediatric Dentistry, Pediatric Dentistry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fathi A Qasem, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Pediatric Dentistry Faculty of Dentistry Thamar University Yemen

Salwa M Awad, Prof

Role: STUDY_DIRECTOR

Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

Rizk A ELagamy, PhD

Role: STUDY_DIRECTOR

Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

Locations

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Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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Qasem FA, Awad SM, Elagamy RA. Effectiveness of Calcium Hydroxide and Gingerols Mixture as a Novel Obturation Material for Infected Root in Primary Teeth: A Randomized Clinical Trial. Int J Dent. 2024 Feb 8;2024:5528260. doi: 10.1155/2024/5528260. eCollection 2024.

Reference Type DERIVED
PMID: 38362239 (View on PubMed)

Other Identifiers

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06030718

Identifier Type: -

Identifier Source: org_study_id

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