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Completed

NCT Number: NCT04770792

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

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.

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Key information

Conditions

Indirect Pulp Treatment

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, Mecca Region, Jeddah 21589, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2% chlorhexidine gluconate with mineral trioxide aggregate.

Other

2% chlorhexidine gluconate with mineral trioxide aggregate.

Mineral trioxide aggregate.

Other

Mineral trioxide aggregate.

Primary outcomes

  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:

    • Spontaneous pain.
    • Pain on percussion.
    • Signs of abscess or fistula.
    • 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:

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

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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