Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07210762

Gingival Cleft Development at Two Time Points of Canine Retraction

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gingival Cleft Gingival Diseases Mouth Diseases Orthodontic Space Closure Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahria University of Health Sciences Karachi

Karachi, Sindh, Pakistan

Location status: Recruiting

Location contact

Ali Umar

CONTACT

[email protected]

+923345624708

Ali Umar

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early space closure

Other

Space closure will be started 1 week after extraction

Delayed space closure

Other

Space closure will be started 8 weeks after extraction

Primary outcomes

  1. presence of gingival clefts after space closure initiation

    Time frame: 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 outcomes

  1. craniofacial growth pattern

    Time frame: craniofacial growth pattern will be measured at baseline

    craniofacial growth pattern from sum of posterior angles

  2. gingival biotype

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

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

  3. buccal bone dehiscence

    Time frame: 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.

  4. canine bulbosity

    Time frame: will be measured at baseline

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

Sponsors and collaborators

Lead sponsor

Bahria University

Other

Registry information

Official study title

Gingival Cleft Development at Two Time Points of Canine Retraction: a Split-mouth Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.