Efficacy of Turmeric in Gingival Massaging and Adjunct to Scaling and Root Planing in Chronic Periodontitis Patient

• ClinicalTrials.gov Identifier: NCT02890771
• Recruitment Status: Completed
• First Posted: September 7, 2016
• Last Update Posted: March 15, 2017
• Sponsor: Government College of Dentistry, Indore
• Information provided by (Responsible Party): SAURABH KUMAR DUBEY, Government College of Dentistry, Indore

Tracking Information

• First Submitted Date: September 1, 2016
• First Posted Date: September 7, 2016
• Last Update Posted Date: March 15, 2017
• Study Start Date: January 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 6, 2016): Plaque Index (Turesky modification of Quigley Hein Index, 1970) [ Time Frame: baseline ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2016)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Chronic Periodontitis

Intervention

• Procedure: Tooth Brushing with Dentifrice
  Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).
• Procedure: Turmeric Massaging
  :-Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with whole Turmeric Powder.
• Procedure: 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

Study Arms

• Active Comparator: Tooth Brushing
  Tooth brushing with dentifrice
  Interventions:

  • Procedure: Turmeric Massaging
  • Procedure: SRP with turmeric massaging
• Experimental: Turmeric massaging
  Tooth Brushing,massaging with whole turmeric powder
  Interventions:

  • Procedure: Tooth Brushing with Dentifrice
  • Procedure: SRP with turmeric massaging
• Experimental: SRP with turmeric massaging
  SRP with turmeric massaging on half arch
  Interventions:

  • Procedure: Tooth Brushing with Dentifrice
  • Procedure: Turmeric Massaging

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2017): 91
• Original Estimated Enrollment (submitted: September 6, 2016): 90
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02890771
• Other Study ID Numbers: GDCHIndore
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: SAURABH KUMAR DUBEY, Government College of Dentistry, Indore
• Study Sponsor: Government College of Dentistry, Indore
• Collaborators: Not Provided

Investigators

• Study Chair: Dr Subhash Garg, MDS; Govt. Dental College, Indore

• PRS Account: Government College of Dentistry, Indore
• Verification Date: March 2017