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临床试验/NCT07210762
NCT07210762招募中不适用

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

Bahria University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
19
试验地点
1
主要终点
presence of gingival clefts after space closure initiation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Extraction advised of both first premolars from either maxilla, mandible or both.
  • •All permanent dentition present apart from third molars.

排除标准

  • •Severe crowding
  • •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.

研究组 & 干预措施

Early movement group

Experimental

Canine retraction will be started 1 week after extraction

干预措施: Early space closure (Other)

Delayed Movement

Experimental

Canine retraction will be started 8 weeks after extraction

干预措施: Delayed space closure (Other)

结局指标

主要结局

presence of gingival clefts after space closure initiation

时间窗: 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

次要结局

  • craniofacial growth pattern(craniofacial growth pattern will be measured at baseline)
  • gingival biotype(At baseline (immediately prior to tooth extraction))
  • buccal bone dehiscence(Immediately post extraction)
  • canine bulbosity(will be measured at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Umar

Postgraduate Resident

Bahria University

研究点 (1)

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