Efficacy of Turmeric in Gingival Massaging and Adjunct to Scaling and Root Planing in Chronic Periodontitis Patient
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tooth Brushing with Dentifrice
Turmeric Massaging
SRP with turmeric massaging
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Periodontitis focused on measuring Turmeric, 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Tooth Brushing
Turmeric massaging
SRP with turmeric massaging
Arm Description
Tooth brushing with dentifrice
Tooth Brushing,massaging with whole turmeric powder
SRP with turmeric massaging on half arch
Outcomes
Primary Outcome Measures
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Secondary Outcome Measures
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Gingival Index (Loe H and Silness J 1963)
Gingival Index (Loe H and Silness J 1963)
Gingival Index (Loe H and Silness J 1963)
Gingival Index (Loe H and Silness J 1963)
Gingival Index (Loe H and Silness J 1963)
Russell's Periodontal Index (Rusell's A.L, 1956)
Russell's Periodontal Index (Rusell's A.L, 1956)
Russell's Periodontal Index (Rusell's A.L, 1956)
Russell's Periodontal Index (Rusell's A.L, 1956)
Russell's Periodontal Index (Rusell's A.L, 1956)
Periodontal Probing Depth
Periodontal Probing Depth
Periodontal Probing Depth
Periodontal Probing Depth
Periodontal Probing Depth
Clinical Attachment Levels
Clinical Attachment Levels
Clinical Attachment Levels
Clinical Attachment Levels
Clinical Attachment Levels
Full Information
NCT ID
NCT02890771
First Posted
September 1, 2016
Last Updated
March 14, 2017
Sponsor
Government College of Dentistry, Indore
1. Study Identification
Unique Protocol Identification Number
NCT02890771
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government College of Dentistry, Indore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Turmeric, Chronic periodontitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tooth Brushing
Arm Type
Active Comparator
Arm Description
Tooth brushing with dentifrice
Arm Title
Turmeric massaging
Arm Type
Experimental
Arm Description
Tooth Brushing,massaging with whole turmeric powder
Arm Title
SRP with turmeric massaging
Arm Type
Experimental
Arm Description
SRP with turmeric massaging on half arch
Intervention Type
Procedure
Intervention Name(s)
Tooth Brushing with Dentifrice
Intervention Description
Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).
Intervention Type
Procedure
Intervention Name(s)
Turmeric Massaging
Intervention Description
:-Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with whole Turmeric Powder.
Intervention Type
Procedure
Intervention Name(s)
SRP with turmeric massaging
Intervention Description
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
Primary Outcome Measure Information:
Title
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time Frame
1 week
Title
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time Frame
2 week
Title
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time Frame
4 week
Title
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time Frame
6 week
Title
Gingival Index (Loe H and Silness J 1963)
Time Frame
baseline
Title
Gingival Index (Loe H and Silness J 1963)
Time Frame
1 week
Title
Gingival Index (Loe H and Silness J 1963)
Time Frame
2 week
Title
Gingival Index (Loe H and Silness J 1963)
Time Frame
4 week
Title
Gingival Index (Loe H and Silness J 1963)
Time Frame
6 week
Title
Russell's Periodontal Index (Rusell's A.L, 1956)
Time Frame
baseline
Title
Russell's Periodontal Index (Rusell's A.L, 1956)
Time Frame
1 week
Title
Russell's Periodontal Index (Rusell's A.L, 1956)
Time Frame
2 week
Title
Russell's Periodontal Index (Rusell's A.L, 1956)
Time Frame
4 week
Title
Russell's Periodontal Index (Rusell's A.L, 1956)
Time Frame
6 week
Title
Periodontal Probing Depth
Time Frame
baseline
Title
Periodontal Probing Depth
Time Frame
1 week
Title
Periodontal Probing Depth
Time Frame
2 week
Title
Periodontal Probing Depth
Time Frame
4 week
Title
Periodontal Probing Depth
Time Frame
6 week
Title
Clinical Attachment Levels
Time Frame
baseline
Title
Clinical Attachment Levels
Time Frame
1 week
Title
Clinical Attachment Levels
Time Frame
2 week
Title
Clinical Attachment Levels
Time Frame
4 week
Title
Clinical Attachment Levels
Time Frame
6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Subhash Garg, MDS
Organizational Affiliation
Govt. Dental College, Indore
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26447754
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.
Results Reference
background
PubMed Identifier
25654020
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.
Results Reference
background
PubMed Identifier
22554269
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.
Results Reference
background
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Efficacy of Turmeric in Gingival Massaging and Adjunct to Scaling and Root Planing in Chronic Periodontitis Patient
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