UnknownNot Applicable

Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction

India40 participantsStarted 2022-01-05

Plain-language summary

To test the null hypothesis that there are no differences in the OHRQOL and clinical outcomes in patients undergoing palatal canine disimpaction using either open or closed surgical method.

Who can participate

Age range

13 Years – 25 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:Patients with palatally ectopic maxillary canines who required surgical exposure and orthodontic alignment * Age 13-25 years Minimal orthodontic problems other than the ectopic canine * Good oral hygiene and motivated to wear fixed appliances for at least 2 years Exclusion Criteria: Compromising medical conditions (patients requiring antibiotic prophylaxis to prevent infective endocarditis) * Periodontal disease (bleeding on probing, pocket probing depths \_3 mm and decreased bone levels as diagnosed from baseline panoramic imaging) * Cases in which the canine is to be brought into the position of the lateral incisor.

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

Oral health based Quality of life (Annexure 1; page 1 and page 2)

Timeframe: pre-treatment and 1 month post treatment (average duration of treatment 18 months )

Post- surgical Oral health based Quality of life (24 hours after surgical exposure) (Annexure 1; page 3)

Timeframe: 24 hours after surgical exposure

Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)

Timeframe: 10th day after surgical exposure

Clinical outcomes - periodontal (Annexure 1; page 5)

Timeframe: Three month post debond

Maxillary canine aesthetic index (Annexure 1; page 7)

Timeframe: one month after debond

Trial details

NCT IDNCT01917604

SponsorJamia Millia Islamia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01

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