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临床试验/NCT02638740
NCT02638740已完成不适用

To Assess the Efficacy of Mustard Oil and Salt Massage as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis: A Clinical Study

Government College of Dentistry, Indore1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年6月1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
54
试验地点
1
主要终点
Plaque Index (Turesky modification of Quigely Hein Index, 1970)

研究概览

简要总结

Periodontal disease is a chronic inflammatory process accompanied by destruction of Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially in developing and underdeveloped countries affecting more than 80% population. Epidemiological studies have shown that about 10% of the adult population suffer from severe periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion is not strictly a localized process but may lead to systemic alterations in immune system. Various studies confirm the microbial etiology of periodontal disease.

详细描述

Periodontal disease is a chronic inflammatory process accompanied by destruction of Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially in developing and underdeveloped countries affecting more than 80% population. Epidemiological studies have shown that about 10% of the adult population suffer from severe periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion is not strictly a localized process but may lead to systemic alterations in immune system. Various studies confirm the microbial etiology of periodontal disease. The bacteria that cause periodontitis include mainly diversity of anerobic bacteria; Porphyromonas Gingivalis, Fusobacterium Nucleatum, Peptostreptococcus, Prevotella species being the most significant.

Various therapeutic approaches are available for treatment of this disease utilizing non surgical and surgical methods, but the treatment is still challenging for the clinician and cumbersome for the patients. In many cases of moderate to severe chronic periodontitis anti- inflammatory and antibiotics are used as an adjunct. Systemic antibiotic agents may reduce or eliminate microbes that cannot be removed by Scaling and Root Planing. This includes microbes that have penetrated tissues or root surfaces which may act as reservoir for recolonization. However synthetic antibiotics and anti-inflammatory agents result in complications like drug resistance, gastrointestinal complications, congestive heart failures and renal failures and other complications.

Especially in India Mustard Oil and Salt is long being used for gum massage and for maintenance and improvement of Oral Hygiene. As this practice of using homemade formulation is beneficial for Gingival and Periodontal health, economic and free from any major side effects it should be studied to document its efficacy as an adjunct to Scaling and Root Planing. Mustard oil is considered to have low saturated fat. The monounsaturated fatty acids and proper ratio of polyunsaturated fatty acids improve heart health, lowers triglyceride, prevents obesity. Massage with mustard oil relieves rheumatism and arthritis, sprains and aches. The selenium present in the oil reduces effects of asthma and joint pain. High level of Vit. E improves skin health and impart protection against UV rays. Mustard seeds are effective in gastrointestinal and colorectal cancer, as mustard is rich in glucosinolate and phytonutrients. It is effective in curing cold, cough, body pains & aches. Salt in topical formulation is found to have anti inflammatory action.Hence this study aims to evaluate this versatile formulation in treatment of Chronic Periodontitis. As the use of Mustard Oil and Salt is practiced by a strata of population in our country thus it is advisable and necessary to assess scientifically the efficacy of mustard oil and salt massage in improving Gingival and Periodontal Health.

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
None

入排标准

年龄范围
28 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects with moderate to severe Chronic Generalized Periodontitis
  • •Not undergone any major periodontal treatment in past 6 months
  • •Otherwise clinically healthy patients

排除标准

  • •Any known systemic diseases specially Diabetes and other major diseases.
  • •Patients on anti-inflammatory drugs or antibiotics
  • •Patient allergic to any material used for the study
  • •Pregnant and lactating mothers
  • •Periodontal therapy in past 6 months
  • •Smoker and tobacco chewer

研究组 & 干预措施

SCALING AND ROOT PLANING (SRP)

Active Comparator

Scaling and root planning with ultrasonic scalar

干预措施: SCALING AND ROOT PLANING (SRP) (Procedure)

MUSTARD OIL AND SALT MASSAGE WITH SRP

Experimental

Scaling and root planing was done with ultrasonic scalar. It was followed by gum massaging with 0.32gm salt in 5ml mustard oil for 5min, twice daily for 90 days.

干预措施: SCALING AND ROOT PLANING (SRP) (Procedure)

MUSTARD OIL AND SALT MASSAGE WITH SRP

Experimental

Scaling and root planing was done with ultrasonic scalar. It was followed by gum massaging with 0.32gm salt in 5ml mustard oil for 5min, twice daily for 90 days.

干预措施: MUSTARD OIL AND SALT MASSAGE WITH SRP (Procedure)

结局指标

主要结局

Plaque Index (Turesky modification of Quigely Hein Index, 1970)

时间窗: Baseline

2 surfaces of all tooth measured

次要结局

  • Papillary Bleeding Index (Saxer and Muhlemann, 1975)(12 week)
  • Russels Periodontal Index(Baseline)
  • Clinical Attachment Level (CAL)(12 week)
  • Mobility Index (S.C Miller 1974)(Baseline)
  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)(12 week)
  • Probing pocket depth (PPD)(12 week)
  • Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)(12 week)
  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)(1 week)
  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)(2 week)
  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)(4 week)
  • Plaque Index (Turesky modification of Quigely Hein Index, 1970)(8 week)
  • Probing pocket depth (PPD)(Baseline)
  • Probing pocket depth (PPD)(1 week)
  • Probing pocket depth (PPD)(2 week)
  • Probing pocket depth (PPD)(4 week)
  • Probing pocket depth (PPD)(8 week)
  • Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)(Baseline)
  • Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)(1 week)
  • Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)(2 week)
  • Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)(4 week)
  • Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)(8 week)
  • Clinical Attachment Level (CAL)(Baseline)
  • Clinical Attachment Level (CAL)(1 week)
  • Clinical Attachment Level (CAL)(2 week)
  • Clinical Attachment Level (CAL)(4 week)
  • Clinical Attachment Level (CAL)(8 week)
  • Papillary Bleeding Index (Saxer and Muhlemann, 1975)(Baseline)
  • Papillary Bleeding Index (Saxer and Muhlemann, 1975)(1 week)
  • Papillary Bleeding Index (Saxer and Muhlemann, 1975)(2 week)
  • Papillary Bleeding Index (Saxer and Muhlemann, 1975)(4 week)
  • Papillary Bleeding Index (Saxer and Muhlemann, 1975)(8 week)

研究者

发起方
Government College of Dentistry, Indore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Trishna Mhapsekar

Dr.

Government College of Dentistry, Indore

研究点 (1)

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