Clinical trial NCT04770792: The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars
Official title: The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indirect Pulp Treatment
Keywords: Indirect pulp treatment
Deep caries
Primary molars
Mineral trioxide aggregate
2% chlorhexidine gluconate
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Data Recording Sheet for Intraoral Clinical Examination
timeFrame: 12 months
measure: Data Recording Sheet for Periapical Radiographic Evaluation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
state: Makkah
Study officials:
affiliation: Phd student at Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz University.
name: Afnan M Saber, MSc
role: PRINCIPAL_INVESTIGATOR
References: