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临床试验/CTRI/2024/06/068548
CTRI/2024/06/068548已完成3 期

Effectiveness of ozonated oil versus chlorhexidine gel in patients with chronic periodontitis- A randomized control trial

Avishek Singh1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年6月24日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
effectiveness of ozonated oil over chlorhexidine gel in the treatment of chronic periodontitis

研究概览

简要总结

Chronic periodontitis a common oral disease among the adult population, characterized as an inflammatory condition affecting the tissues that support teeth, brought on by certain microorganisms. It can induce gingival recession, periodontal pocket formation, or progressive deterioration of the alveolar bone and periodontal ligament. The deposition of plaque on teeth and the gingival sulcus is thought to be the main cause of the genesis of chronic periodontitis and gingivitis.of the best non-surgical treatments available is scaling and root planning (SRP), which lowers the bacterial load in addition to reducing dental calculus and plaque. Antimicrobial treatments must be used in addition to mechanical debridement in places that are difficult to access, such as deep pockets and furcation areas. A popular and efficient antibacterial agent used as a supplement after scaling and root planing (SRP) is chlorhexidine (CHX). . It should be mentioned moreover, that CHX shows greater cytotoxic effects and other adverse effects like staining and altered taste sensation. In the recent past, a significant surge in research interest in natural medicine has been seen.. Of particular note, plant products have become widely used in the field of microbiology. Although there are many novel therapeutic strategies which involves using medicinal plants and their products, the application of the same is appealing and is being studied more and more. Recently, there has been a resurgence of interest in oils, and their possible antibacterial properties are beginning to be acknowledged. Adding ozone to these substances may further increase anti bacterial efficacy. In addition to comparing the outcomes with regular SRP with traditional chlorhexidine gel, this study is being done with the primary aim to evaluate the effectiveness of topical ozone oil application.

Methodology:

Population: Patients with chronic periodontitis

Intervention: Scaling + Ozonated oil

Comparator: Scaling + Chlorhexidine gel

Outcome: Reduction in the degree of chronic peridontitis

Study design: Randomized controlled trial

Sample size: 56 patients

Groups: Two ( Group 1 and Group 2)

Study tool: A detailed case history will be recorded in a specially designed perfoma which include patient’s demographic details, contact information, past medical and dental history, deleterious habits (if any), oral hygiene habits i.e. brushing method, technique and dentrifice used, extra oral and intra oral examination. Following clinical indices were measured at baseline and folllowup-:  Plaque index measured using Turesky- Gilmore  -Glickman modification of the Quigley-Hein Plaque index(1970), GI measured using Loe H and Sillness J Gingival index (1963),  Periodontal probing depth measured using Periodontal probe (distance measured  from the  gingival margin to the pocket base) and Clinical attachment level (measured from CEJ to base of pocket). Consent form duly signed by the patient after explanation of the study purpose and methodology before the commencement of  the study will be obtained. Two treatment arms of the study will be-:

•        For group 1 Complete Oral Prophylaxis will be done and patients will be advised to apply Ozone oil daily for a period of one month.

•        For group 2 Complete Oral Prophylaxis will be done and patients will be advised to apply chlorhexidine gel daily for a period of one month.

Recall and Clinical evaluation- Follow up will be done at a period of 1 month  i.e. 30 days from the start of the treatment and  3 months i.e. 90 days from the start of the study  to check the following parameters- Modified PI, GI by loe and sillness, periodontal PPD and loss of attachment measured by CAL).

Outcome will be measured in terms of reduction of the scores of these indices so as to assess the effectiveness of the intervention group in the disease condition as well as to compare it with the comparator group

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from chronic periodontitis with a minimum of at least 10 teeth present in each arch.
  • Bleeding on probing
  • Pocket depth of at least 3 mm
  • Loss of attachment more than 2 mm.

排除标准

  • Patient with history of any systemic disease such as diabetes, hypertension, anaemia and systemic disease related to periodontitis.
  • Patients with fixed prosthesis, removable prosthesis or any orthodontic appliance.
  • Pregnancy or breastfeeding.
  • Use of systemic drugs in last 3 months.
  • Patients who have undergone scaling and root planing in the last 6 month.

结局指标

主要结局

effectiveness of ozonated oil over chlorhexidine gel in the treatment of chronic periodontitis

时间窗: Baseline, 1 month and 3 months

次要结局

  • Reduction of plaque score after scaling and root planing and topical application of ozone oil(Baseline, 1 month and 3 months)
  • Reduction of gingival score after scaling and root planing and topical application of ozone oil(Baseline, 1 month and 3 months)
  • Reduction of periodontal probing depth after scaling and root planing and topical application of ozone oil(Baseline, 1 month and 3 months)
  • Reduction of clinical attachment level after scaling and root planing and topical application of ozone oil(Baseline, 1 month and 3 months)

研究者

发起方
Avishek Singh
申办方类型
Other [Dental surgeon]
责任方
Principal Investigator
主要研究者

Avishek Singh

NIMS Dental College and Hospital, Jaipur

研究点 (1)

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