Comparison and assessment of pain and dentoskeletal changes in cleft patients during rapid maxillary expansion - a randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To measure the Predesignating (PGE2) expression and VAS score
研究概览
简要总结
Cleft lip and palate (CLP) is a common craniofacial defect that affects about one in every 800 births.1 The treatment of patients affected by cleft lip and palate (CLP) presents many challenges in multi-disciplinary management. Orthodontic treatment is often required over many years for any midface deficiencies.
As a consequence, the growth and development of the maxillary segments are compromised by scar tissues, thus inducing maxillary constriction, particularly in the anterior region. Rapid maxillary expansion (RME) is commonly used to correct this transverse deficiency.2,3 Often, the goal of Rapid maxillary expansion (RME) for many cleft patients has been to increase the anterior maxillary expansion and restrain the posterior expansion, since there is a greater anterior than posterior maxillary constriction in most of these patients. 4,5
Pain and discomfort are some of the most common side effects reported by the patients after RME screw activation6 . There are studies evaluating pain during maxillary expansion using different scales, but none of the studies done previously have evaluated the pain during rapid maxillary expansion in unilateral cleft patients by assessing PGE2 during different intervals between hyrax expander and fan-type expander. The rationale for conducting this study is to assess the pain intensity with hyrax expander and fan-type expander
â— Patients were divided into 2 groups-
â— Group 1: Patients with unilateral cleft who will undergo maxillary expansion with hyrax expander will be involved in this group pre-expansion and post-expansion (after 2 weeks of expansion) lateral cephalograms and posteroanterior cephalograms, and gingival crevicular fluid (GCF) sample is taken from them. The levels of prostaglandin E2 in GCF, the Visual Analog Scale (VAS) scores and the dentoskeletal effects will be evaluated.
â— Group 2: Patients with unilateral cleft who will undergo maxillary expansion with fan-type expander will be involved in this group pre-expansion and post-expansion (after 2 weeks of expansion) lateral cephalograms and posteroanterior cephalograms, and gingival crevicular fluid (GCF) sample is taken from them. The levels of prostaglandin E2 in GCF, the Visual Analog Scale (VAS) scores and the dentoskeletal effects will be evaluated
â— After the intervention is given, the levels of prostaglandin E2 in GCF, the Visual Analog Scale (VAS) scores and the dentoskeletal effects will be evaluated and compared between the hyrax expander group and fan-type expander group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with non-syndromic cleft lip and palate 2.Patients with unilateral cleft. 3.Patients undergoing orthodontic treatment with rapid maxillary expansion. 4.Patient of both genders within the age group of 10 yrs.
- •15 yrs. • No history of previous orthodontic treatment.
排除标准
- •1.Smokers/ Individual with pan chewing habit 2.Patients with any systematic conditions 3.History of antibiotic or anti-inflammatory drug therapy in the past 7 days.
结局指标
主要结局
To measure the Predesignating (PGE2) expression and VAS score
时间窗: 1 hour before insertion of expander: baseline (T0); | day 1 - 15minutes after activation of expander (T1); day 4 - 15minutes after activation of expander (T2); day 7 - 15minutes after activation of expander (T3).
次要结局
- 4. To measure the dentoskeletal effects in hyrax expander group & fan-type expander group(pre-expansion radiographs (baseline))
研究者
Nivedha R
Sri Ramachandra Institute of Higher Education and Research