Gingival Cleft Development at Two Time Points of Canine Retraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early space closure, Delayed space closure.
- Who it may be relevant to
- Registry conditions: Gingival Cleft, Orthodontic Space Closure. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gingival Cleft Development at Two Time Points of Canine Retraction: a Split-mouth Randomized Controlled Trial
Overview
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.
Interventions
- Other Early space closure
Space closure will be started 1 week after extraction - Other Delayed space closure
Space closure will be started 8 weeks after extraction
Primary outcome measures
- presence of gingival clefts after space closure initiation [Time frame: start of canine retraction to its completion (approximately 6 months)]
Secondary outcome measures (4)
- craniofacial growth pattern [Time frame: craniofacial growth pattern will be measured at baseline]
- gingival biotype [Time frame: At baseline (immediately prior to tooth extraction)]
- buccal bone dehiscence [Time frame: Immediately post extraction]
- canine bulbosity [Time frame: will be measured at baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Bahria University of Health Sciences Karachi — Karachi
Identifiers
NCT: NCT07210762 · BUHS-IRB # 174/25