NCT02890771

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

September 1, 2016

Last Update Submit

March 14, 2017

Conditions

Keywords

TurmericChronic periodontitis

Outcome Measures

Primary Outcomes (1)

  • Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    baseline

Secondary Outcomes (24)

  • Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    1 week

  • Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    2 week

  • Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    4 week

  • Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    6 week

  • Gingival Index (Loe H and Silness J 1963)

    baseline

  • +19 more secondary outcomes

Study Arms (3)

Tooth Brushing

ACTIVE COMPARATOR

Tooth brushing with dentifrice

Procedure: Turmeric MassagingProcedure: SRP with turmeric massaging

Turmeric massaging

EXPERIMENTAL

Tooth Brushing,massaging with whole turmeric powder

Procedure: Tooth Brushing with DentifriceProcedure: SRP with turmeric massaging

SRP with turmeric massaging

EXPERIMENTAL

SRP with turmeric massaging on half arch

Procedure: Tooth Brushing with DentifriceProcedure: Turmeric Massaging

Interventions

Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).

SRP with turmeric massagingTurmeric massaging

:-Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with whole Turmeric Powder.

SRP with turmeric massagingTooth Brushing

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

Tooth BrushingTurmeric massaging

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26447754BACKGROUND
  • 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.

    PMID: 25654020BACKGROUND
  • 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.

    PMID: 22554269BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

ToothbrushingDentifrices

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistryBiomedical and Dental MaterialsCosmeticsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Dr Subhash Garg, MDS

    Govt. Dental College, Indore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate student

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 15, 2017

Record last verified: 2017-03