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临床试验/NCT03410602
NCT03410602已完成1 期

Effect on Nonsurgical Periodontal Therapy on First Molars Banded for Fixed Orthodontic Treatment

Meenakshi Ammal Dental College and Hospital0 个研究点目标入组 30 人开始时间: 2016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
1 期
状态
已完成
发起方
入组人数
30
主要终点
Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month

研究概览

简要总结

The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first molars banded for fixed orthodontic treatment.

详细描述

A total of 30 patients who were about to undergo fixed orthodontic therapy were selected and divided into two groups.

Group A comprised of 15 patients who were treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars.

Group B comprised of 15 patients who were treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Treatment for both the groups was performed at 3rd month, 6th month and 9th month.

Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. The differences between the values were assessed and sent for statistical analysis.

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
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Both male and female patients within the age group 16 to 25 years.
  • Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars.
  • Systemically healthy patients.

排除标准

  • Congenital malformations in the oral cavity.
  • Patients who had undergone periodontal therapy within the previous 6 months.
  • Patients using removable orthodontic appliances.
  • Patients who were administered antibiotics or other systemic or topical antimicrobial agents.

研究组 & 干预措施

Supragingival and subgingival scaling

Placebo Comparator

Supragingival and subgingival scaling group comprised of 15 orthodontic patients treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.

干预措施: Full-mouth supragingival scaling (Procedure)

Supragingival and subgingival scaling

Placebo Comparator

Supragingival and subgingival scaling group comprised of 15 orthodontic patients treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.

干预措施: Subgingival scaling (Procedure)

Subgingival irrigation

Active Comparator

Subgingival irrigation group comprised of 15 orthodontic patients treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.

干预措施: Full-mouth supragingival scaling (Procedure)

Subgingival irrigation

Active Comparator

Subgingival irrigation group comprised of 15 orthodontic patients treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.

干预措施: Subgingival scaling (Procedure)

Subgingival irrigation

Active Comparator

Subgingival irrigation group comprised of 15 orthodontic patients treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.

干预措施: Subgingival irrigation (Drug)

结局指标

主要结局

Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month

时间窗: Baseline to 12th month

Radiographic evidence of alveolar crestal bone level was measured around each banded first molar

次要结局

  • Change from baseline probing pocket depth at 12th month(Baseline to 12th month)
  • Change from baseline gingival index at 12th month(Baseline to 12th month)
  • Change from baseline plaque index at 12th month(Baseline to 12 month)
  • Change from baseline clinical attachment level at 12th month(Baseline to 12th month)

研究者

发起方
Meenakshi Ammal Dental College and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Jaideep Mahendra

Professor

Meenakshi Ammal Dental College and Hospital

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