RecruitingNot Applicable

Gingival Cleft Development at Two Time Points of Canine Retraction

Pakistan19 participantsStarted 2025-10-15

Plain-language summary

The goal of this split-mouth randomized controlled trial is to assess whether the timing of extraction space closure-early vs. delayed initiation-affects the incidence of gingival cleft development in orthodontic patients. The main question it aims to answer is: Does the incidence of gingival cleft development get influenced by the specific time point at which orthodontic space closure is initiated following extraction? Quadrants will be assigned to the early movement group and the other to the delayed movement group and extractions will be performed accordingly. These will be assessed for the effect on development of gingival cleft development.

Who can participate

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

. Extraction advised of both first premolars from either maxilla, mandible or both.
. All permanent dentition present apart from third molars.

Exclusion criteria

. Severe crowding
. Smokers
. Patients with systemic diseases that could interfere with bone remodeling.
. Patients with periodontitis or poor periodontal health.
. Patients who have previously undergone periodontal surgery in the area of interest.
. Patients with other oral health conditions that could complicate the treatment or healing process.

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

presence of gingival clefts after space closure initiation

Timeframe: start of canine retraction to its completion (approximately 6 months)

Trial details

NCT IDNCT07210762

SponsorBahria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-19

View on ClinicalTrials.gov More Gingival Cleft trials