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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
Government College of Dentistry, Indore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Periodontitis focused on measuring Turmeric, Chronic periodontitis

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 1, 2016
    Last Updated
    March 14, 2017
    Sponsor
    Government College of Dentistry, Indore
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    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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