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

January 6, 2023 updated by: Fathi Abdulraqeb Qasem, Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Ginge-Cal group:
primary molars were filled by creamy mixture pulpectomy paste of Gingerols and Calcium Hydroxide.
Procedure: Ginge-Cal
Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal)
Active Comparator: Group 2: Metapex group
primary molars were filled by a ready-made injectable creamy mixture pulpectomy paste of Metapex
Procedure: Metapex
Fill the infected root canal of of primary teeth with Metapex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of primary teeth with control necrotic pulp by clinical examination
Time Frame: 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.
Up to 18 months
Percentage of primary teeth with control necrotic pulp by radiographic examination
Time Frame: 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
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Fathi A Qasem, PhD, Assistant Professor of Pediatric Dentistry Faculty of Dentistry Thamar University Yemen
  • Study Director: Salwa M Awad, Prof, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
  • Study Director: Rizk A ELagamy, PhD, Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06030718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study Protocol to other researchers

IPD Sharing Time Frame

Within 6 Months

IPD Sharing Access Criteria

For anyone

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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