Gingival Cleft Development at Two Time Points of Canine Retraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBahria University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Extraction advised of both first premolars from either maxilla, mandible or both.
All permanent dentition present apart from third molars.
Disqualifiers
Severe crowding
Smokers
Patients with systemic diseases that could interfere with bone remodeling.
Patients with periodontitis or poor periodontal health.
Trial design
Design model
Parallel
Treatments tested in this trial
Early space closure
Other interventionSpace closure will be started 1 week after extraction
Delayed space closure
Other interventionSpace closure will be started 8 weeks after extraction
Treatment groups
19 Participants
are divided into 2 treatment groupsGroup A: Early movement groupExperimental treatment 1 intervention
Group B: Delayed MovementExperimental treatment 1 intervention
Trial outcomes
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 baseline2
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 extraction4
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 baselineSponsors and contacts
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Source ClinicalTrials.gov