CompletedNot Applicable

Evaluation of Lesion Sterilization and Tissue Repair Techniques Versus Pulpectomy in Primary Molars With Inflammed Pulp

Egypt66 participantsStarted 2022-09-20

Plain-language summary

Group I (Experimental group I): Lesion Sterilization and Tissue Repair with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals. Group II (Experimental group II): Lesion Sterilization and Tissue Repair with no radicular instrumentation. Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix. Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol.

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: * Molars should be restorable. * Mandibular second primary molars with deep caries, vital carious pulp exposure, irreversible pulpitis. * Mobility: Non or grade I. * Radiographic signs of minimal external root resorption. Exclusion Criteria: * Children with known allergy to the agents used. * Children with infective endocarditis. * Refusal of participation. * Unable to attend follow-up visits.

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

Clinical success "binary"

Timeframe: 12 months

Radiographic success "binary"

Timeframe: 12 months

Trial details

NCT IDNCT05336682

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Pulpitis - Irreversible trials