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临床试验/CTRI/2025/07/091377
CTRI/2025/07/091377
尚未招募
2 期

A Comparative Evaluation of Efficacy of Systemically and Locally Delivered Muskmallow (Abelmoschus moschatus) Seed Extracts as an Adjunct to Scaling And Root Planing in Generalized Moderate to Severe Chronic Periodontitis Patients: A Randomized Double Blinded Placebo Controlled Clinical Trial.

Dr. Madhu Varma1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年8月5日最近更新:

概览

阶段
2 期
状态
尚未招募
发起方
Dr. Madhu Varma
入组人数
84
试验地点
1
主要终点
Modified Gingival index

概览

简要总结

Oral health is integral to general health and essential for wellbeing. Despite impressive improvements in oral health because of much better oral hygiene maintenance, problems still remain in many places around the world1. Oral cavity is a favourable habitat for a variety of bacteria due to the constant presence of nutrients and secretions. Some bacteria of normal oral flora are pathogenic and cause harm to the host. Many of these organisms are responsible for the formation of plaque which in turn is responsible for diseases like dental caries, gingivitis and periodontitis. Mechanical removal of dental biofilm is a key factor in the prevention of oral diseases. The tools most commonly used in mechanical plaque control are the toothbrushes (manual or electric), floss, woodsticks and interdental brushes11. Despite the availability of various oral hygiene devices, even the most meticulous person will not always completely remove all the plaque. The recognized inadequacies in the mechanical plaque control practices of many individuals has fuelled a year-long search for chemical agents to control plaque.

Chemotherapeutic mouthrinses endow with chemically significant benefit in the reduction of plaque induced gingivitis. Mouthrinses encompass the ability to deliver therapeutic ingredients and benefits to all accessible surfaces in the mouth including interproximal surfaces. They also remain effective for unmitigated period of time depending on their substantivity. Mature, intact biofilms hinder the action of chemotherapeutic agents. Hence antimicrobial agents have to be used adjunctively to scaling and root planing and not as first line of treatment in the management of periodontitis. To date no single chemotherapeutic agent is found to target all pathogens harbouring the periodontal pocket. These limitations force us to use a combination of antimicrobials and a judicious selection of antimicrobials targeting the pathogens is quite essential. But synthetic antimicrobials and anti-inflammatory agent have side effects and result in complications like drug resistance, gastrointestinal complications, congestive heart failures, renal failures, allergic reactions, which may at times be life-threatening. Also there are side effects of various mouthwashes such as tooth and tongue staining, taste alterations, and mucosal erosions that limit patient compliance. Today dentists are practicing in an era where the patients are more concerned about their oral health and their overall wellbeing. Thus, in the midst of growing evidence of the connection between oral and systemic health, herbal medicines with their ‘naturally occurring’ active ingredients offer a gentle and enduring solution for restoration of health in a more trustworthy and least harmful way.

Traditional medicine is deep rooted and grounded deep in India and is being used here since times immemorial. Ayurvedic medicine is a system used by Indians and is native to the Indian subcontinent as a form of alternative medicine. It has also attracted much attention in developed countries such as Europe, United States and Japan. Charka samhita and Sushutra samhita have been the basis of ayurvedic medicine since a long time.

Rationale

During past two decades reliability and usage of herbal products has assumed increasing importance, due to the side effects and complications of many chemical and synthetic medicines. About 25% of drugs are derived from plants and many other are formed from prototype compounds isolated from plant species. These medicines contain natural phytochemicals in them and offer an effective alternative to antibiotics and represent a promising approach in the prevention and therapeutic strategies for oral infections too. Because of relatively safe nature of herbal extracts, many herbal products and their component are being used for treating periodontitis in the form of local drug delivery as well systemically**.**Therefore, the purpose of this study was to evaluate the effects of systemic and locally delivered  Muskmallow (Abelmoschus moschatus) seed extracts as an adjunct to scaling and root planing in patients with generalized moderate to severe chronic periodontitis.

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 and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with generalized moderate to severe chronic periodontitis.
  • Patients in age group of
  • 65 years of either sex.
  • Patients with at least 20 natural teeth.
  • Patient ready to give written informed consent.
  • Systemically healthy patients.

排除标准

  • Patients on antibiotic or antimicrobial therapy in last 6 months.
  • Smokers and smokeless tobacco users.
  • Patients who have received periodontal treatment in the past 6 months.
  • Pregnant and lactating mothers.
  • Patients allergic to any material used in study.

结局指标

主要结局

Modified Gingival index

时间窗: 1week | 1 month

Papillary bleeding Index

时间窗: 1week | 1 month

Plaque index

时间窗: 1week | 1 month

Probing pocket depth

时间窗: 1week | 1 month

Pocket probing depth

时间窗: 1week | 1 month

Clinical attachment loss

时间窗: 1week | 1 month

Radiographic evaluation of bone level

时间窗: 1week | 1 month

次要结局

  • Clinical attachment loss(Radiographic evaluation of bone level)

研究者

发起方
Dr. Madhu Varma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Madhu Varma

Government Dental College and Hospital, Chhatrapati Sambhajinagar

研究点 (1)

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