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

Primary Purpose

Primary Teeth, Pulp Necroses, Infected Pulp

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Ginge-Cal

Metapex

About this trial

This is an interventional treatment trial for Primary Teeth focused on measuring Pediatric Dentistry, Pulpectomy, Infected Pulp, Necrotic Pulp, Gingerols, Calcium Hydroxide, Metapex, Ginge-Cal

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
Parents signed the consent to participate in the study.
Absence of any systemic disease, which would contraindicate pulp therapy.
Child didn't have any history of a sensitive reaction to any component of used materials.
Present half to two third of tooth root or more
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.

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Ginge-Cal group:

Group 2: Metapex group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05181813

First Posted

November 30, 2021

Last Updated

January 6, 2023

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05181813

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 17, 2020 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Teeth, Pulp Necroses, Infected Pulp, Root Canal Treatment

Keywords

Pediatric Dentistry, Pulpectomy, Infected Pulp, Necrotic Pulp, Gingerols, Calcium Hydroxide, Metapex, Ginge-Cal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Ginge-Cal group:

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2: Metapex group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Ginge-Cal

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Metapex

Intervention Description

Fill the infected root canal of of primary teeth with Metapex

Primary Outcome Measure Information:

Title

Percentage of primary teeth with control necrotic pulp by clinical examination

Description

Time Frame

Up to 18 months

Title

Percentage of primary teeth with control necrotic pulp by radiographic examination

Description

Time Frame

Up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments. Parents signed the consent to participate in the study. Absence of any systemic disease, which would contraindicate pulp therapy. Child didn't have any history of a sensitive reaction to any component of used materials. Present half to two third of tooth root or more 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fathi A Qasem, PhD

Organizational Affiliation

Assistant Professor of Pediatric Dentistry Faculty of Dentistry Thamar University Yemen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Salwa M Awad, Prof

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rizk A ELagamy, PhD

Organizational Affiliation

Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry

City

Mansoura

State/Province

Dakahlia

ZIP/Postal Code

35511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study Protocol to other researchers

IPD Sharing Time Frame

Within 6 Months

IPD Sharing Access Criteria

For anyone

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

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