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临床试验/CTRI/2022/08/045119
CTRI/2022/08/045119尚未招募不适用

CLINICAL EVALUATION AND COMPARISON OF EFFICACY OF COMBINATION GEL CONTAINING ALOE VERA AND NEEM AS AN ADJUNCT TO SCALING AND ROOT PLANNING IN CHRONIC PERIODONTITIS – An in-vivo study

Dr Sherin S Antony1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年5月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
1. Pocket Probing depth

研究概览

简要总结

Periodontitis is the mostcommon and a major public health problem due to its high prevalence which is25% to 55% worldwide, and also because it leads to tooth loss, and alsodegrades the quality of life. (1) Periodontal therapy includes bothmechanical and chemical therapeutic agents which help in the reduction orelimination of microbial biofilm.

Conventional plaquecontrol (scaling and root planing [SRP] and ultrasonic debridement has reducedeffectiveness because it lacks accessibility to micro-organisms in the sub-gingival environment. (2) Adjunctive chemotherapies enhance theresults at sites not responsive to conventional mechanical therapy. (2)The administrations of systemicantimicrobial drugs have failed to achieve the adequate concentration at therequired sites and its frequent usage has led to bacterial resistance. (3)Local drug delivery system proves beneficial because of their ability to reachthe base of the periodontal pocket and also causes sustained release of shortdose of drug over a long period of time. It has shown promising results in mildand moderate chronic periodontitis. (4)

Herbal medicine containsnatural phytochemicals and are highly effective substitutes to antimicrobialagents which signify an alternative approach in the preventive and therapeuticmanagement of oral and periodontal infections. (3) They act holisticallyto improve symptoms, regress the disease progression, correct imbalance andadjust the immune system. (5) In the arena of local drug delivery,literature also shows effective use of herbs like curcumin, green tea,aloe-vera, Acacia catechu, Azadirachta indica and pomegranate. (3)

Aloe vera (Aloe barbadensis miller) belongs to the family: Liliaceae and is frequently being usedas herbal medicine. (6) Aloe vera gel has an inhibitory effecton Aggregatibacter actinomycetemcomitans,Porphyromonas gingivalis which wereisolated from patients with periodontitis and Bacteroides fragilis isolated from patients with dental caries.(6) Aloe vera gel has alsobeen used as local drug delivery system in periodontal pockets and hasexhibited encouraging findings in clinical parameters which resulted inimprovement of periodontal condition. (7)

Neem tree known as Azadirachta indica belongsto family: Meliaceae. Various pharmacologicalactivities such as antioxidant, antimicrobial, anti-inflammatory,anti carcinogenic properties has been earlier reported by different parts ofneem tree. (8) Neem gel when delivered as Local Drug Delivery hasshown statistically significant reduction in Plaque Index, Gingival Index,Pocket probing depth and a mean decrease inthe gram positive cocci, gram negative cocci, gram positive bacilli and gramnegative bacilli when compared to the control group. (9)

There have been no reportedclinical studies using a combination of Aloevera and Neem as a Local Drug Delivery agents in periodontitis. Therefore,in the present study, the effects of a combination gel containing Aloe vera and Neem will be evaluated andcompared as an adjunct to scaling and root planing in the treatment of chronicperiodontitis.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Minimum of 20 teeth should be present.
  • Age – 20 years and above.
  • Systemically healthy patient.
  • Patients with chronic periodontitis (AAP 1999 Classification of periodontitis) having pocket probing depth of >4mm in contralateral quadrants.
  • Patients who have not undergone any form of dental treatment (non-surgical or surgical therapy) in the last 6 months including oral prophylaxis.

排除标准

  • Patient with a history of antibiotics and non-steroidal anti-inflammatory drug use in the past 6 months.
  • Pregnant women and lactating mothers.
  • Smokers and patients consuming tobacco in any form.
  • Immuno-compromised patients.
  • Patient not willing to participate in the study.

结局指标

主要结局

1. Pocket Probing depth

时间窗: 2 weeks follow up

2. clinical attachment level

时间窗: 2 weeks follow up

3. Plaque index

时间窗: 2 weeks follow up

次要结局

  • 1. Oral hygiene maintenance,(2. Patients satisfaction)

研究者

发起方
Dr Sherin S Antony
申办方类型
Other []

研究点 (1)

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