Clinical trial NCT02890771: Efficacy of Turmeric in Gingival Massaging and Adjunct to Scaling and Root Planing in Chronic Periodontitis Patient
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Turmeric
Chronic periodontitis
Lead sponsor: Government College of Dentistry, Indore
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 91
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: baseline
Secondary outcomes:
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 1 week
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 2 week
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 4 week
measure: Plaque Index (Turesky modification of Quigley Hein Index, 1970)
timeFrame: 6 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: baseline
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 1 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 2 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 4 week
measure: Gingival Index (Loe H and Silness J 1963)
timeFrame: 6 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: baseline
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 1 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 2 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 4 week
measure: Russell's Periodontal Index (Rusell's A.L, 1956)
timeFrame: 6 week
measure: Periodontal Probing Depth
timeFrame: baseline
measure: Periodontal Probing Depth
timeFrame: 1 week
measure: Periodontal Probing Depth
timeFrame: 2 week
measure: Periodontal Probing Depth
timeFrame: 4 week
measure: Periodontal Probing Depth
timeFrame: 6 week
measure: Clinical Attachment Levels
timeFrame: baseline
measure: Clinical Attachment Levels
timeFrame: 1 week
measure: Clinical Attachment Levels
timeFrame: 2 week
measure: Clinical Attachment Levels
timeFrame: 4 week
measure: Clinical Attachment Levels
timeFrame: 6 week
Other outcomes:
Locations:
Study officials:
affiliation: Govt. Dental College, Indore
name: Dr Subhash Garg, MDS
role: STUDY_CHAIR
References:
citation: Izui S, Sekine S, Maeda K, Kuboniwa M, Takada A, Amano A, Nagata H. Antibacterial Activity of Curcumin Against Periodontopathic Bacteria. J Periodontol. 2016 Jan;87(1):83-90. doi: 10.1902/jop.2015.150260. Epub 2015 Oct 8.
citation: Farjana HN, Chandrasekaran SC, Gita B. Effect of oral curcuma gel in gingivitis management - a pilot study. J Clin Diagn Res. 2014 Dec;8(12):ZC08-10. doi: 10.7860/JCDR/2014/8784.5235. Epub 2014 Dec 5.
citation: Zhou T, Chen D, Li Q, Sun X, Song Y, Wang C. Curcumin inhibits inflammatory response and bone loss during experimental periodontitis in rats. Acta Odontol Scand. 2013 Mar;71(2):349-56. doi: 10.3109/00016357.2012.682092. Epub 2012 May 4.