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临床试验/NCT06305546
NCT06305546已完成不适用

Comparison Of Different Antiplaque Agents On Gingivitis In Patients Undergoing Fixed Orthodontic Treatment: A Double-Blind, Randomized Controlled Trial.

Anam Sattar1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
gingival index

研究概览

简要总结

Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis

详细描述

Metal brackets were used on the teeth such as incisors, canines, and premolars as well as bands on the 1st molars to treat all patients with the same kind of orthodontic appliances. Metal Brackets were bonded by the principal investigator with the direct bonding technique by using light cure adhesives. General oral hygiene instructions were given by the clinician to each participant in the study.

Participants were divided into four groups through computer-generated software. Group A participants used 1% metronidazole gel, Group B participants used 0.25% chlorhexidine gel. Group C participants used a combination gel (1% Metronidazole and 0.25% Chlorhexidine). Group D participants used a placebo gel. All participants were instructed to follow oral hygiene measures such as brushing twice a day with a soft brush with fluoridated toothpaste, and use of floss or interdental brushes. For two weeks, all individuals from groups A, B, C, and D were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, the investigators assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.

OUTCOMES:

The primary outcome included the measurement of indices during study time from baseline (T0) to 2weeks (T1), 4 weeks (T2), 8 weeks (T3) and 12 weeks(T4) . The investigators have evaluated Gingival Index and Bleeding Index by probing and assessing the gingiva and Orthodontic Plaque index by plaque disclosing tablets, and examined six standard sites on incisors, canine, and premolars as described by Gettinger et al. Banded first molars were not included because banding itself can compromise periodontal health. The study sites were assessed by using CPITN probe. Six proximal line angles were investigated for gingivitis on the selected teeth: Right maxillary second premolar, mesiobuccal line angle; right maxillary canine, distobuccal line angle; left maxillary central incisor, distopalatal line angle; right mandibular central incisor, distolingual line angle; left mandibular canine, distobuccal line angle; left mandibular second premolar, mesiobuccal line angle.

If any of the study teeth were missing, then the corresponding tooth on the opposite side was evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The trial was a double blinded (patients and investigators). We were helped from a member of our department who is not a part of the study, to transfer the gels from commercial tubes to blank containers. The randomization codes remained unknown until data analysis was completed. Randomization was done by computer-generated software.

入排标准

年龄范围
16 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

group A

Experimental

干预措施: Chlorhexidine Gluconate (Drug)

GROUP B

Experimental

干预措施: Metronidazole (Drug)

GROUP C

Experimental

干预措施: combination gel (chlorhexidine and metronidazole) (Drug)

GROUP D

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

gingival index

时间窗: 12 weeks

Gingival index Score 0: no inflammation Score 1: Mild inflammation of gingiva. No bleeding on probing. Score2: Moderate inflammation, Red, edematous and shiny gingiva, bleeding on probing. Score 3: Severe inflammation, Red, edematous and ulcerated gingiva. There is spontaneous bleeding

bleeding index

时间窗: 12 weeks

Bleeding Index Score 0: absence of bleeding after 30 seconds Score 1: presence of bleeding after 30 seconds Score 2: immediate bleeding

orthodontic plaque index

时间窗: 12 weeks

Orthodontic Plaque Index 0: No plaque deposits on the tooth surfaces surrounding the bracket base 1. Plaque deposits on one tooth surface at the bracket base 2. Plaque deposits on two tooth surfaces at the bracket base 3. Plaque deposits on three tooth surfaces at the bracket base 4. Plaque deposits on four tooth surfaces at the bracket base

次要结局

未报告次要终点

研究者

发起方
Anam Sattar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anam Sattar

Senior Registrar, Department of Orthodontics, Principal Investigator.

Dow University of Health Sciences

研究点 (1)

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