CompletedNot Applicable

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

Saudi Arabia40 participantsStarted 2019-04-06

Plain-language 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.

Who can participate

Age range

4 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Data Recording Sheet for Intraoral Clinical Examination

Timeframe: 12 months

Data Recording Sheet for Periapical Radiographic Evaluation

Timeframe: 12 months

Trial details

NCT IDNCT04770792

SponsorKing Abdulaziz University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Indirect Pulp Treatment trials