Gingival Cleft Development at Two Time Points of Canine Retraction

NCT07210762 | Recruiting

• 1 other identifier: BUHS-IRB # 174/25
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Cleft; Orthodontic Space Closure

Keywords

gingival cleft; Orthodontic Space Closure; gingiva; gingival disease; tooth extraction; tooth socket

Outcome Measures

Primary Outcomes (1)

• presence of gingival clefts after space closure initiation

  The primary outcome will be the presence of gingival clefts, which will be measured at 3 months and 6 months after space closure initiation

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

Secondary Outcomes (4)

• craniofacial growth pattern

  craniofacial growth pattern will be measured at baseline

• gingival biotype

  At baseline (immediately prior to tooth extraction)

• buccal bone dehiscence

  Immediately post extraction

• canine bulbosity

  will be measured at baseline

Study Arms (2)

Early movement group

EXPERIMENTAL

Canine retraction will be started 1 week after extraction

Other: Early space closure

Delayed Movement

EXPERIMENTAL

Canine retraction will be started 8 weeks after extraction

Other: Delayed space closure

Interventions

Early space closure OTHER

Space closure will be started 1 week after extraction

Early movement group

Delayed space closure OTHER

Space closure will be started 8 weeks after extraction

Delayed Movement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Bahria University of Health Sciences Karachi

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident

Model Details: split-mouth randomized controlled study

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: October 7, 2025
• Study Start: October 15, 2025
• Primary Completion: March 19, 2026
• Study Completion (Estimated): July 19, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-08

Locations

PA (1)