Gingival Cleft Development at Two Time Points of Canine Retraction

NCT ID: NCT07210762

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2026-07-19

Brief Summary

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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

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Conditions

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Gingival Cleft Orthodontic Space Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

split-mouth randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early movement group

Canine retraction will be started 1 week after extraction

Group Type EXPERIMENTAL

Early space closure

Intervention Type OTHER

Space closure will be started 1 week after extraction

Delayed Movement

Canine retraction will be started 8 weeks after extraction

Group Type EXPERIMENTAL

Delayed space closure

Intervention Type OTHER

Space closure will be started 8 weeks after extraction

Interventions

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Early space closure

Space closure will be started 1 week after extraction

Intervention Type OTHER

Delayed space closure

Space closure will be started 8 weeks after extraction

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bahria University

OTHER

Sponsor Role lead

Responsible Party

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Ali Umar

Postgraduate Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bahria University of Health Sciences Karachi

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Facility Contacts

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Ali Umar

Role: primary

+923345624708

Other Identifiers

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BUHS-IRB # 174/25

Identifier Type: -

Identifier Source: org_study_id

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