CompletedPhase 2/3

Effect of Use of Calcium Hydroxide and Metformin Intracanal Medicament After NSRCT

India120 participantsStarted 2023-08-01

Plain-language summary

Goal of this randomized clinical trial is evaluate the effect of Calcium Hydroxide and Metformin Intracanal Medicament on periapical healing after NSRCT. Population includes systemically healthy patient with radiographic evidence of apical periodontitis PAI score more then 3 will be recruited . Outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period.

Who can participate

Age range

18 Years – 55 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

. Mature permanent mandibular molar with necrotic pulp (absence of response to cold and electric pulp tester) and apical periodontitis requiring primary root canal treatment with radiographic evidence of periapical radiolucency (periapical index score ≥ 3).
. Age - Above 18 years
. Non-contributory medical history (ASA 1)
. Periodontally healthy tooth (probing depth \<4mm)

Exclusion criteria

. Patients who do not provide authorization for participation in the study
. History of analgesic intake in the previous 1 week, or antibiotic intake in 1 month

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

periapical healing using the Periapical index score

Timeframe: 6 and12 months follow .

Trial details

NCT IDNCT06766201

SponsorPostgraduate Institute of Dental Sciences Rohtak

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Apical Periodontitis trials