Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatments tooth brushing with dentifrice, turmeric massaging, srp with turmeric massaging
Sponsor Government College of Dentistry, Indore
Start date January 2016
End date September 2016
Trial size 90 participants
Trial identifier NCT02890771, GDCHIndore

Summary

Periodontal disease is considered as inflammatory, multifactorial, and threshold disease accompanied by destruction of periodontium and eventually the loss of natural teeth. Periodontal disease is highly prevalent dental disease especially, in developing and underdeveloped countries affecting more or less 80% of the population. For the prevention of this highly prevalent dental affliction, still no effective and practical preventive measures are available which can reduce its high prevalence rate though, lot of research work is going on.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Tooth brushing with dentifrice
turmeric massaging
:-Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with whole Turmeric Powder.
srp with turmeric massaging
on one side of the arch only Scaling and Root Planing(SRP) to be done, while on the other side, after the Scaling and Root Planing massaging with whole Turmeric Powder shall be carried out by the patients/subjects
(Experimental)
Tooth Brushing,massaging with whole turmeric powder
tooth brushing with dentifrice
Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).
srp with turmeric massaging
on one side of the arch only Scaling and Root Planing(SRP) to be done, while on the other side, after the Scaling and Root Planing massaging with whole Turmeric Powder shall be carried out by the patients/subjects
(Experimental)
SRP with turmeric massaging on half arch
tooth brushing with dentifrice
Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).
turmeric massaging
:-Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with whole Turmeric Powder.

Primary Outcomes

Measure
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
time frame: baseline

Secondary Outcomes

Measure
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
time frame: 1 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
time frame: 2 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
time frame: 4 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
time frame: 6 week
Gingival Index (Loe H and Silness J 1963)
time frame: baseline
Gingival Index (Loe H and Silness J 1963)
time frame: 1 week
Gingival Index (Loe H and Silness J 1963)
time frame: 2 week
Gingival Index (Loe H and Silness J 1963)
time frame: 4 week
Gingival Index (Loe H and Silness J 1963)
time frame: 6 week
Russell's Periodontal Index (Rusell's A.L, 1956)
time frame: baseline
Russell's Periodontal Index (Rusell's A.L, 1956)
time frame: 1 week
Russell's Periodontal Index (Rusell's A.L, 1956)
time frame: 2 week
Russell's Periodontal Index (Rusell's A.L, 1956)
time frame: 4 week
Russell's Periodontal Index (Rusell's A.L, 1956)
time frame: 6 week
Periodontal Probing Depth
time frame: baseline
Periodontal Probing Depth
time frame: 1 week
Periodontal Probing Depth
time frame: 2 week
Periodontal Probing Depth
time frame: 4 week
Periodontal Probing Depth
time frame: 6 week
Clinical Attachment Levels
time frame: baseline
Clinical Attachment Levels
time frame: 1 week
Clinical Attachment Levels
time frame: 2 week
Clinical Attachment Levels
time frame: 4 week
Clinical Attachment Levels
time frame: 6 week

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

Inclusion Criteria: - Cases with moderate to severe form of Generalized Chronic Periodontitis patients of any sex. - Patients in the age group of 35-65 years, who abide by approved protocol guidelines, and are ready to give written informed consent. Exclusion Criteria: - Any known systemic disease which has effects on periodontium such as diabetes etc. - Patients on anti-inflammatory, antibiotics and perioceutics, since 3 months. - Patients who have known allergy to material used for the study. - Pregnant and lactating mothers. - Patients had undergone any kind of non-surgical and/or surgical periodontal therapy earlier, in past 6 months. - Tobacco users.

Additional Information

Official title To Evaluate the Efficacy of Whole Turmeric Powder in Gingival Massaging and as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis
Description Various interceptive and therapeutic modalities are available comprising of non-surgical and surgical therapies. But, these therapies are not available for everyone, due to various reasons such as low socio-economic conditions of the majority of the population including poverty, illiteracy, and malnutrition etc. along with low dentist: population ratio. Moreover, the availability of a dentist and/or periodontist is limited in rural and remote areas, whereas the prevalence rate of periodontal disease is comparatively higher in these areas than that of urban areas. Looking to these difficulties, the investigators have to think and explore the beneficial effects by conducting research work on various home care measures which are being used since many generations, especially in our country and thus people were/are enjoying the benefits with almost all or many natural teeth, up to last span of their lives.Though, the scientific evidences of beneficial effects of home care measures for cleaning and massaging of teeth and gums, respectively are not yet evident significantly. But, traditional uses of various dentifrices those are still in practices and thus need scientific attentions. Now, the investigators are in the evidence based era, especially in the field of medical sciences. Therefore, the number of research studies should be planned and carried out at various centres in different parts of the country, to ascertain the beneficial effects of traditional oral hygiene practices such as: Datoons (Neem, Babool etc), leaves of various plants like Mango, Charcoal powder, Meswak, salt, Mustard oil with Salt, and Turmeric powder and other such home care dental cleansing materials. After getting the beneficial information's/evidences accordingly, the uses of specific traditional materials and methods for the cleansing of the teeth and massaging of the gums can be advocated. And thus, specifically the developing and underdeveloped countries may be benefitted. Out of various home care dental cleansing materials the Turmeric powder is not only being used as one of important condiments of our kitchen, and at the same time as a medicinal use since ages. The 'Turmeric' is known for its anti-inflammatory, antioxidant, antimicrobial, immune stimulant, antiseptic, anti-carcinogenic, and anti-mutagenic properties [1]. Drake [2] and Han et al [3], observed anti- microbial activity of Turmeric. Roobal Bahal et al [4] stated that on use of 2% Turmeric gel, significant reduction in the mean plaque index, gingival index, sulcus bleeding index, probing pocket depth and significant reduction in trypsin like enzymatic activity of "Red-Complex" microorganisms. Ruchika Jaswal et al [5] conducted a pilot study to evaluate and compare the clinical effects of topical subgingival application of 2% whole turmeric gel and 1% chlorhexidine gel as an adjunct to scaling and root planing (SRP) in patients suffering from chronic periodontitis. Very few studies, which can be counted on fingers, have been conducted worldwide in this direction. Hence, this study is being taken to evaluate the efficacy of whole Turmeric Powder in Gingival Massaging and as an adjunct to Scaling and Root Planing in Patients with Chronic Periodontitis.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Government College of Dentistry, Indore.