Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars (NCT07319741) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars
Egypt44 participantsStarted 2026-02
Plain-language summary
This study will evaluate the clinical and radiographic outcomes of rotary versus manual pulpectomy in children with irreversible pulpitis.A single-visit pulpectomy will be performed for all patients. Participants will be allocated to rotary instrumentation using Fanta AF Baby files or manual step-back instrumentation with K-files. Canals will be irrigated with 17% EDTA and 1% sodium hypochlorite, obturated with Metapex, and restored with glass ionomer cement and stainless-steel crowns. Primary outcomes will assess clinical success at 3, 6, 9, and 12 months, while secondary outcomes will evaluate postoperative pain and radiographic success at 6 and 12 months.
Who can participate
Age range
5 Years – 7 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:
* Children aged 5-7 years with irreversible pulpitis of primary molars.
* History of spontaneous pain with a deep carious lesion.
* Parents who approve to write informed consent.
Exclusion Criteria:
* Medically compromised children.
* Children with a history of allergic reaction to the materials used in the study.
* Children with non-restorable teeth.
* Teeth with resorbed roots (more than two-thirds of root length).
* Extensive internal or external root resorption visible in periapical Radiographs.
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
1
Clinical success of Pulpectomy procedure
Timeframe: 12 months
Trial details
NCT IDNCT07319741
SponsorAnfal mohamed elmotaz almogtaba
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-02
Contact for this trial
Anfal Mohammed Almogtaba, Bechlor's degree in dentistry