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临床试验/NCT06567405
NCT06567405已完成不适用

Impact of Derma Pen in the Treatment of Gingivitis Induced by Orthodontic Therapy

Safa Basiouny Alawy1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
gingival index (GI)

研究概览

简要总结

Although orthodontic therapy frequently improves tooth alignment and appearance, its problems with oral hygiene can make patients highly susceptible to gingivitis. After orthodontic treatment, gingivitis is a typical problem. New treatments that promote healing and decrease inflammation are needed. Ascorbic acid and Derma Pen used together have recently surfaced as a potentially effective therapy option for patients who seeking for periodontal therapy during and after orthodontic treatments.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients age: 18-25 years .
  • •systemically healthy patients.
  • •mild to moderate plaque-induced gingivitis patients during orthodontic therapy

排除标准

  • •periodontitis.
  • •individuals who smoke or those who have tobacco related habits.
  • •partially edentulous individuals.
  • •individuals who are diagnosed with drug-induced gingival enlargement.
  • •Pregnant or lactating women

研究组 & 干预措施

group I: dermapen and topical ascorbic Acid

Experimental

12 individuals who have orthodontically induced gingivitis will be treated with dermapen and topical ascorbic Acid

干预措施: Derma pen with topical ascorbic Acid (Device)

group II: mechanical periodontal treatment

Active Comparator

12 individuals who have orthodontically induced gingivitis will receive mechanical periodontal treatment only

干预措施: mechanical periodontal treatment (Procedure)

结局指标

主要结局

gingival index (GI)

时间窗: one month

gingival index will be calibrated using William's probe approximately 1 to 2 mm to the margin of the gingiva at an angulation of 45 degree to document the gingival inflammation signs of the upper six anterior teeth. Each of the four surfaces of the anterior teeth (buccal, lingual, mesial, and distal) will be given a score from 0 to 3 and then areas were added and divided by four to give the accurate GI of each tooth. Score 0 = No signs of inflammation, bleeding, or swelling. Score 1= Presence of signs of mild inflammation, slight edema, and color change but no bleeding. Score 2 = Presence of moderate inflammation, redness, swelling, and bleeding on probing. Score 3 = Presence of severe inflammation, marked redness, edema, and spontaneous bleeding.

次要结局

  • Plaque Index (PI)(one month)

研究者

发起方
Safa Basiouny Alawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Safa Basiouny Alawy

Lecturer of Orthodontics

Tanta University

研究点 (1)

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