Effect of extraction-space closure timing on gingival cleft formation during canine movement
Gingival Cleft Development at Two Time Points of Canine Retraction: a Split-mouth Randomized Controlled Trial
This test will see if starting space closure early versus waiting changes how often gingival clefts form in orthodontic patients after premolar extractions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Sex | All |
| Sponsor | Bahria University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07210762 on ClinicalTrials.gov |
What this trial studies
This is a split-mouth randomized controlled trial where quadrants are allocated to early versus delayed initiation of canine retraction after premolar extraction. Each participant will have one side treated early and the opposite side treated later, and gingival cleft development will be recorded at two time points. The main outcome is the incidence of gingival cleft formation associated with the timing of space closure. The single-center trial will enroll patients who need extraction of both first premolars and meet periodontal and systemic health criteria.
Who should consider this trial
Good fit: Ideal candidates are orthodontic patients requiring extraction of both first premolars with full permanent dentition (except third molars), good periodontal health, non-smokers, and no systemic conditions affecting bone remodeling.
Not a fit: Patients with periodontitis, poor periodontal health, smokers, those with systemic diseases affecting bone remodeling, or prior periodontal surgery in the area are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, choosing the optimal timing for space closure could reduce gingival clefts and improve gum health and appearance after orthodontic extractions.
How similar studies have performed: Existing literature on timing of space closure and gingival clefts is limited and findings are mixed, so this approach is relatively novel in its specific focus.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Extraction advised of both first premolars from either maxilla, mandible or both. 2. All permanent dentition present apart from third molars. Exclusion Criteria: 1. Severe crowding 2. Smokers 3. Patients with systemic diseases that could interfere with bone remodeling. 4. Patients with periodontitis or poor periodontal health. 5. Patients who have previously undergone periodontal surgery in the area of interest. 6. Patients with other oral health conditions that could complicate the treatment or healing process.
Where this trial is running
Karachi, Sindh
- Bahria University of Health Sciences Karachi — Karachi, Sindh, Pakistan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.