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临床试验/CTRI/2025/07/089952
CTRI/2025/07/089952尚未招募2/3 期

Impact of Full-Thickness Mucoperiosteal Flap Elevation on Orthodontic Tooth Movement in Split-Mouth Extraction Cases: An In-Vivo Study.

Dr Devarshi Hingrajia1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
31
试验地点
1
主要终点
Evaluate and compare rate of space closure after maxillary first premolar extraction with and without full thickness mucoperiosteal flap elevation.

研究概览

简要总结

This will be a split-mouth study. Thirty-one patients undergoing orthodontic treatment will be selected. Each participant will be treated using a fixed pre-adjusted appliance with a metal 0.022 x 0.028” slot MBT prescription bracket system. Detailed information about the study will be provided, and written informed consent will be obtained.

Study Phases:Phase I – Initial Orthodontic Phase: Orthodontic bonding and banding will be performed. Levelling and alignment will be done using 0.014" and 0.016" NiTi archwires, followed by 0.019 x 0.025" NiTi wires. Maxillary first premolars will be extracted after alignment.

Allocation Method: In each patient, one side of the maxillary arch will be randomly designated as the experimental side and the opposite as control. The experimental side will be selected by lottery for the first patient, and then alternated for the rest.

  • Control group: Conventional extraction.
  • Experimental group: Extraction with elevation of a Full-Thickness Mucoperiosteal Flap (FTMPF).

Phase II – Surgical Intervention: Control side extraction will be done three days before the test side. On the experimental side, after local anesthesia, a trapezoidal FTMPF will be raised in the canine-premolar region using a No. 15 blade and Molt No. 9 elevator. A sulcular incision will be made from the mesial of the second premolar to the mesial of the canine, avoiding the canine eminence. Palatal mucosa will be elevated using a tunneling technique. First premolars will be extracted on both sides using premolar forceps. The sockets will be irrigated with saline, and the flap on the test side will be sutured with 3-0 black braided silk.

Postoperative Instructions: Cap. Amoxicillin 500 mg (TID) and Tab. Paracetamol 650 mg (BID) will be given for three days. Patients will be advised to avoid spitting, gargling, and hot/hard foods for one week.

Phase III – Retraction Phase: A 0.019 x 0.025” stainless steel archwire will be inserted on both sides on the same day. En-masse retraction will begin using 12 mm NiTi closed coil springs from the power arm mesial to the canine to the molar tube. Force will be standardized at 150g using a Dontrix gauge.

Results: Canine retraction will be evaluated monthly for four months using study models. The distance moved by the canine will be measured from the cusp tip to a reference plane perpendicular to the occlusal plane just mesial to the first molar, using a Digital Vernier Caliper.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patients who give consent for the study.
  • Patients requiring fixed orthodontic treatment.
  • Good oral hygiene and healthy periodontium before starting the treatment.
  • No history of previous orthodontic treatment.
  • All of the permanent dentition present excluding third molars.
  • Cases indicated for extraction of the maxillary first premolars and canine retraction into the extraction space with maximum anchorage.
  • Malocclusion cases that allow initial stage of leveling and alignment without extraction.
  • Patients without syndromes affecting the cranial region or any craniofacial injuries present.

排除标准

  • Patients with systemic diseases like Diabetes mellitus, especially bleeding disorders and osteoporosis.
  • Patients with history of administration of corticosteroids, immunosuppressants, exogenous hormones and other non-steroidal anti-inflammatory drugs (all drugs interfering with OTM).
  • Patients with previous history of oral surgeries in maxillary arch.

结局指标

主要结局

Evaluate and compare rate of space closure after maxillary first premolar extraction with and without full thickness mucoperiosteal flap elevation.

时间窗: Impression will be taken at baseline, after 1 month, after 2 months, after 3 months and at 4th month.

次要结局

未报告次要终点

研究者

发起方
Dr Devarshi Hingrajia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Devarshi Hingrajia

Manubhai Patel Dental College and Hospital

研究点 (1)

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