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Gingival Cleft Development at Two Time Points of Canine Retraction

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07210762
Enrollment
19
Registered
2025-10-07
Start date
2025-10-15
Completion date
2026-07-19
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Cleft, Orthodontic Space Closure

Keywords

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

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.

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

Sponsors

Bahria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

split-mouth randomized controlled study

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
presence of gingival clefts after space closure initiationstart 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

MeasureTime frameDescription
craniofacial growth patterncraniofacial growth pattern will be measured at baselinecraniofacial growth pattern from sum of posterior angles
gingival biotypeAt baseline (immediately prior to tooth extraction)gingival biotype by measuring thickness of gingiva using spreader of size 15
buccal bone dehiscenceImmediately post extractionbone 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.
canine bulbositywill be measured at baselineMaximum height of contour of canine will be measured on the pretreatment cast using the digital vernier caliper

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026