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

Not Applicable

Completed

• Conditions: Indirect Pulp Treatment
• Interventions: Other: 2% chlorhexidine gluconate with mineral trioxide aggregate.; Other: Mineral trioxide aggregate.

• Registration Number: NCT04770792
• Lead Sponsor: King Abdulaziz University

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.

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 Timeline

• Study Start: 2019-04-06
• Primary Completion: 2020-12-31
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Study Completion: 2021-06-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	2% chlorhexidine gluconate with mineral trioxide aggregate.	2% chlorhexidine gluconate with mineral trioxide aggregate.
Control group	Mineral trioxide aggregate.	Mineral trioxide aggregate.

Primary Outcome Measures

Name	Time	Method
Data Recording Sheet for Intraoral Clinical Examination	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".
Data Recording Sheet for Periapical Radiographic Evaluation	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".

Trial Locations

Locations (1)

King Abdulaziz University; 🇸🇦 Jeddah, Makkah, Saudi Arabia