跳至主要内容
临床试验/CTRI/2024/04/065849
CTRI/2024/04/065849尚未招募4 期

Comparative evaluation of rate of debonding in orthodontic bonding carried out with and without primer: a randomized clinical trial

Army Dental Centre Research and Referral1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Rate of debonding in direct orthodontic bonding carried out in patients with and without the use of primer

研究概览

简要总结

Orthodontic treatment focuses on dentoalveolar and orthopaedic corrections to restore form, function and esthetics. The brackets form an integral component of fixed orthodontic therapy. The edgewise bracket system was introduced by E.H. Anglein 1928. Initially, these brackets were welded to orthodontic bands and then cemented over the tooth. Later, the technique of acid etching paved way for bonding the brackets directly to the teeth. The bonding materials have evolved significantly since the time of their introduction by Buonocore in 1955 and currently, fourth generation bonding agents are in use in orthodontic bonding. The optimal bond strength required for orthodontic adhesive should be at least 6 – 8 MPa. The use of primer is considered to produce better bonding and ensures high bond strength for treatment success.However, few studies have reported equitable bonding success rate in bonding without primer. Such studies on bonding without the use of primer have usually been carried out under in-vitro conditions or with low sample size but inconclusive results. Thus, controversy in the literature exists regarding the bond failure of brackets with and without the use of primer. Considering the constancy of other factors involved in bond failure  such as age, patient compliance, type of primer, curing lamp and bracket material, bonding with and without primer can be additional factor in determining the success of bonding. This study endeavours to add to the existing sparse literature on this topic of bond failure rate in direct bonding carried out with and without the use of primer. The study will be carried out,  under in-vivo conditions, as a randomized clinical trial to bridge the knowledge gap and provide evidence for clinical usage.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • Skeletal Class I malocclusion requiring fixed orthodontic treatment.
  • Patients with full complement of teeth till first molar in both maxillary and mandibular arches.
  • No deleterious habits.
  • Cases with optimal overjet and overbite.
  • Patient aged 15-30 years.

排除标准

  • Patient involved in aggressive sports.
  • Patients with congenital enamel defects.
  • Patients with buccal surface caries.
  • Patients with congenitally missing teeth.
  • Teeth with anomalies of crown size or shape (peg laterals).

结局指标

主要结局

Rate of debonding in direct orthodontic bonding carried out in patients with and without the use of primer

时间窗: 01 month 02 month 03 month 04 month 05 month 06 month

次要结局

  • Assess the prevelance of debonding by using primer and not using primer(01 month 02 month 03 month 04 month 05 month 06 month)

研究者

发起方
Army Dental Centre Research and Referral
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Maj Prashanth R

Army Dental Cenre, Research and Referral

研究点 (1)

Loading locations...

相似试验

Analyzing the rate of detachment of orthodontic... | 临床试验