Gingival Cleft Development at Two Time Points of Canine Retraction

Not Applicable

Recruiting

• Conditions: Gingival Cleft; Orthodontic Space Closure

• Registration Number: NCT07210762
• Lead Sponsor: Bahria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-10-15
• Primary Completion: 2026-03-19
• Study Completion: 2026-07-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
presence of gingival clefts after space closure initiation	start of canine retraction to its completion (approximately 6 months)	The primary outcome will be the presence of gingival clefts, which will be measured at 3 months and 6 months after space closure initiation

Secondary Outcome Measures

Name	Time	Method
craniofacial growth pattern	craniofacial growth pattern will be measured at baseline	craniofacial growth pattern from sum of posterior angles
gingival biotype	At baseline (immediately prior to tooth extraction)	gingival biotype by measuring thickness of gingiva using spreader of size 15
buccal bone dehiscence	Immediately post extraction	bone dehiscence will be measured utilizing the periodontal probe(in mm) from the distal marginal ridge of premolar as reference point, on both the buccal and palatal/lingual side.
canine bulbosity	will be measured at baseline	Maximum height of contour of canine will be measured on the pretreatment cast using the digital vernier caliper

Trial Locations

Locations (1)

Bahria University of Health Sciences Karachi; 🇵🇰 Karachi, Sindh, Pakistan