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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-06

Study Completion Date

2021-06-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Indirect Pulp Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

2% chlorhexidine gluconate with mineral trioxide aggregate.

Group Type EXPERIMENTAL

2% chlorhexidine gluconate with mineral trioxide aggregate.

Intervention Type OTHER

2% chlorhexidine gluconate with mineral trioxide aggregate.

Control group

Mineral trioxide aggregate.

Group Type ACTIVE_COMPARATOR

Mineral trioxide aggregate.

Intervention Type OTHER

Mineral trioxide aggregate.

Interventions

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2% chlorhexidine gluconate with mineral trioxide aggregate.

Intervention Type OTHER

Mineral trioxide aggregate.

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes