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Chronic PeriodontitisNCT02890771

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

A study testing Tooth Brushing with Dentifrice, Turmeric Massaging and SRP with turmeric massaging in people with Chronic Periodontitis, run by Government College of Dentistry, Indore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis
What is being tested?
Tooth Brushing with Dentifrice, Turmeric Massaging and SRP with turmeric massaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
No sites listed yet
Study dates
Jan 2016to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Read the 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.

Being tested
Tooth Brushing with Dentifrice, Turmeric Massaging, SRP with turmeric massaging
Keywords
Turmeric, Chronic periodontitis
Medical subject headings
Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tooth Brushing with DentifriceProcedure or surgery

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

  • Turmeric MassagingProcedure or surgery

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

  • SRP with turmeric massagingProcedure or surgery

    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 groups in NCT02890771
Study groupRoleWhat they receive
Tooth BrushingActive comparatorTooth brushing with dentifrice
Receives: Procedure: Turmeric Massaging; Procedure: SRP with turmeric massaging
Turmeric massagingExperimentalTooth Brushing,massaging with whole turmeric powder
Receives: Procedure: Tooth Brushing with Dentifrice; Procedure: SRP with turmeric massaging
SRP with turmeric massagingExperimentalSRP with turmeric massaging on half arch
Receives: Procedure: Tooth Brushing with Dentifrice; Procedure: Turmeric Massaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    Measured: baseline

Secondary outcomes (24)
  1. Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    Measured: 1 week

  2. Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    Measured: 2 week

  3. Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    Measured: 4 week

  4. Plaque Index (Turesky modification of Quigley Hein Index, 1970)

    Measured: 6 week

  5. Gingival Index (Loe H and Silness J 1963)

    Measured: baseline

  6. Gingival Index (Loe H and Silness J 1963)

    Measured: 1 week

  7. Gingival Index (Loe H and Silness J 1963)

    Measured: 2 week

  8. Gingival Index (Loe H and Silness J 1963)

    Measured: 4 week

  9. Gingival Index (Loe H and Silness J 1963)

    Measured: 6 week

  10. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: baseline

  11. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 1 week

  12. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 2 week

  13. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 4 week

  14. Russell's Periodontal Index (Rusell's A.L, 1956)

    Measured: 6 week

  15. Periodontal Probing Depth

    Measured: baseline

  16. Periodontal Probing Depth

    Measured: 1 week

  17. Periodontal Probing Depth

    Measured: 2 week

  18. Periodontal Probing Depth

    Measured: 4 week

  19. Periodontal Probing Depth

    Measured: 6 week

  20. Clinical Attachment Levels

    Measured: baseline

  21. Clinical Attachment Levels

    Measured: 1 week

  22. Clinical Attachment Levels

    Measured: 2 week

  23. Clinical Attachment Levels

    Measured: 4 week

  24. Clinical Attachment Levels

    Measured: 6 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02890771
Sponsor's protocol ID
GDCHIndore
Status last verified
Mar 2017
First submitted
1 Sep 2016
Last updated
15 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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.

    PubMed 26447754
  • 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.

    PubMed 25654020
  • 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.

    PubMed 22554269

Questions about this trial

What is this clinical trial studying?

A study testing Tooth Brushing with Dentifrice, Turmeric Massaging and SRP with turmeric massaging in people with Chronic Periodontitis, run by Government College of Dentistry, Indore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque Index (Turesky modification of Quigley Hein Index, 1970) (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02890771, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.

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