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

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ClinicalTrials.gov Identifier: NCT04770792
Recruitment Status : Completed
First Posted : February 25, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Afnan Saber, King Abdulaziz University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Indirect Pulp Treatment Other: 2% chlorhexidine gluconate with mineral trioxide aggregate. Other: Mineral trioxide aggregate. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars: A Randomized Controlled Clinical Trial
Actual Study Start Date : April 6, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : June 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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".

  2. 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".


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770792


Locations
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Saudi Arabia
King Abdulaziz University
Jeddah, Makkah, Saudi Arabia, Jeddah 21589
Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Afnan M Saber, MSc Phd student at Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz University.
More Information
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Responsible Party: Afnan Saber, Principle investigator, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT04770792    
Other Study ID Numbers: ASaber
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Afnan Saber, King Abdulaziz University:
Indirect pulp treatment
Deep caries
Primary molars
Mineral trioxide aggregate
2% chlorhexidine gluconate
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
 Anti-Infective Agents
Disinfectants
Dermatologic Agents