The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars

September 14, 2021 updated by: Afnan Saber, King Abdulaziz University

The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars: A Randomized Controlled Clinical Trial

The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A randomized, split-mouth design including 40 children aged 4-8 years was implemented. The study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair, one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is carried out to evaluate the teeth clinically and radiographically.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A double blinded, randomized, controlled clinical trial was performed in a split-mouth design. Eighty primary molars in forty subjects were randomly allocated that each subject had one tooth treated with 2% chlorhexidine gluconate and MTA (experimental group), and the other tooth treated with only MTA (control group).

The study was held at King Abdulaziz University Dental Hospital (KAUDH), Jeddah. Forty healthy children with the age range 4- to 8-year-old were included. Each patient had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.

Preoperative periapical radiographs of the teeth considered for treatment in the study were made using extension cone paralleling technique in the x ray machine.

The procedure was performed in two visits by one operator to allow for the setting of MTA. Stainless steel crowns were used as final restorations.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Saudi Arabia
    • Makkah
      • Jeddah, Makkah, Saudi Arabia, Jeddah 21589
        • King Abdulaziz University

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient inclusion criteria:

  • 4-8 years old.
  • Healthy.
  • Cooperative.
  • Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.

Teeth inclusion criteria:

  • No spontaneous pain.
  • No pain on palpation or percussion.
  • No signs of fistula or abscess.
  • No abnormal mobility.
  • No radiolucency at the periapical or interradicular areas.
  • No loss of lamina dura.
  • No radiographic signs of internal resorption.
  • Sufficient tooth structure allowing placement of rubber dam.
  • Not expected to exfoliate within 1 year.

Exclusion Criteria:

  • Spontaneous pain.
  • Pain on palpation or percussion.
  • Signs of fistula or abscess.
  • Presence of abnormal mobility.
  • Radiolucency at the periapical or interradicular areas.
  • Loss of lamina dura.
  • Radiographic signs of internal resorption.
  • No sufficient tooth structure allowing placement of rubber dam.
  • Expected to exfoliate within 1 year.

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group
2% chlorhexidine gluconate with mineral trioxide aggregate.
Other: 2% chlorhexidine gluconate with mineral trioxide aggregate.
2% chlorhexidine gluconate with mineral trioxide aggregate.
ACTIVE_COMPARATOR: Control group
Mineral trioxide aggregate.
Other: Mineral trioxide aggregate.
Mineral trioxide aggregate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data Recording Sheet for Intraoral Clinical Examination
Time Frame: 12 months

Data sheet for recording the clinical outcome criteria obtained by intraoral clinical examination is filled by the investigators. The data sheet includes information regarding the presence or absence of the following:

  1. Spontaneous pain.
  2. Pain on percussion.
  3. Signs of abscess or fistula.
  4. Abnormal mobility. The response for each point is interpreted in the form by either "yes" or "no".
12 months
Data Recording Sheet for Periapical Radiographic Evaluation
Time Frame: 12 months

Data sheet for recording the radiographic outcome criteria obtained from periapical radiograph is filled by the investigators. The data sheet includes information regarding the presence or absence of the following:

  1. Radiolucency at the periapical or interradicular areas.
  2. Loss of lamina dura.
  3. Signs of internal root resorption.
  4. Signs of external pathologic root resorption.
  5. Normal root resorption accompanying the exfoliation process. The response for each point is interpreted in the form by either "yes" or "no".
12 months

Collaborators and Investigators

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

Sponsor

King Abdulaziz University

Investigators

  • Principal Investigator: Afnan M Saber, MSc, Phd student at Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz 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)

April 6, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

June 8, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (ACTUAL)

February 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASaber

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Indirect Pulp Treatment

Clinical Trials on 2% chlorhexidine gluconate with mineral trioxide aggregate.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe