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RecruitingNCT07210762Updated Oct 7, 2025

Gingival Cleft Development at Two Time Points of Canine Retraction

An interventional study of Early space closure and Delayed space closure in Gingival Cleft and Orthodontic Space Closure, sponsored by Bahria University. Recruiting at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by Bahria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Gingival Cleft
  • Orthodontic Space Closure

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Keywords

  • gingival cleft
  • Orthodontic Space Closure
  • gingiva
  • gingival disease
  • tooth extraction
  • tooth socket
03

In context

Gingival Diseases

88 studies on the registry are indexed under Gingival Diseases; 23 are open to participants now.

This study's planned enrollment of 19 is below the median of 46 across 69 interventional studies indexed under Gingival Diseases.

Browse Gingival Diseases studies →

Lead sponsor

Bahria University is the lead sponsor of 36 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
19 participants (estimated)

Study arms

  • Experimental
    Early movement group

    Canine retraction will be started 1 week after extraction

    Other: Early space closure

  • Experimental
    Delayed Movement

    Canine retraction will be started 8 weeks after extraction

    Other: Delayed space closure

Interventions

  • OtherEarly space closure

    Space closure will be started 1 week after extraction

  • OtherDelayed space closure

    Space closure will be started 8 weeks after extraction

06

What researchers measure

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

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

Secondary outcomes

  1. craniofacial growth pattern

    craniofacial growth pattern from sum of posterior angles

    Time frame: craniofacial growth pattern will be measured at baseline

  2. gingival biotype

    gingival biotype by measuring thickness of gingiva using spreader of size 15

    Time frame: At baseline (immediately prior to tooth extraction)

  3. buccal bone dehiscence

    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.

    Time frame: Immediately post extraction

  4. canine bulbosity

    Maximum height of contour of canine will be measured on the pretreatment cast using the digital vernier caliper

    Time frame: will be measured at baseline

07

Study locations

1 of 1 sites recruiting
  • Bahria University of Health Sciences Karachi
    Karachi, Sindh, Pakistan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07210762
Lead sponsor
Bahria University
Responsible party
Ali Umar (Postgraduate Resident, Bahria University) — Principal investigator
First posted
Oct 7, 2025
Start date
Oct 15, 2025 (estimated)
Primary completion
Mar 19, 2026 (estimated)
Completion
Jul 19, 2026 (estimated)
Last update
Oct 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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