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.
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Tooth Brushing | Active comparator | Tooth brushing with dentifrice Receives: Procedure: Turmeric Massaging; Procedure: SRP with turmeric massaging |
| Turmeric massaging | Experimental | Tooth Brushing,massaging with whole turmeric powder Receives: Procedure: Tooth Brushing with Dentifrice; Procedure: SRP with turmeric massaging |
| SRP with turmeric massaging | Experimental | SRP 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.
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: baseline
Secondary outcomes (24)
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 1 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 2 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 4 week
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Measured: 6 week
Gingival Index (Loe H and Silness J 1963)
Measured: baseline
Gingival Index (Loe H and Silness J 1963)
Measured: 1 week
Gingival Index (Loe H and Silness J 1963)
Measured: 2 week
Gingival Index (Loe H and Silness J 1963)
Measured: 4 week
Gingival Index (Loe H and Silness J 1963)
Measured: 6 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: baseline
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 1 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 2 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 4 week
Russell's Periodontal Index (Rusell's A.L, 1956)
Measured: 6 week
Periodontal Probing Depth
Measured: baseline
Periodontal Probing Depth
Measured: 1 week
Periodontal Probing Depth
Measured: 2 week
Periodontal Probing Depth
Measured: 4 week
Periodontal Probing Depth
Measured: 6 week
Clinical Attachment Levels
Measured: baseline
Clinical Attachment Levels
Measured: 1 week
Clinical Attachment Levels
Measured: 2 week
Clinical Attachment Levels
Measured: 4 week
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.
- First posted7 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Government College of Dentistry, Indore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAURABH KUMAR DUBEY, Government College of Dentistry, Indore
- Investigators
- Dr Subhash Garg, MDS, Study chair, Govt. Dental College, Indore
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 26447754Farjana 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 25654020Zhou 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02890771
- Acronym / sponsor ID
- GDCHIndore
- Conditions
- Chronic Periodontitis
- Keywords
- Turmeric, Chronic periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Government College of Dentistry, IndoreUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tooth Brushing | Active comparator | Procedure: Turmeric Massaging, Procedure: SRP with turmeric massagingTooth brushing with dentifrice |
| Turmeric massaging | Experimental | Procedure: Tooth Brushing with Dentifrice, Procedure: SRP with turmeric massagingTooth Brushing,massaging with whole turmeric powder |
| SRP with turmeric massaging | Experimental | Procedure: Tooth Brushing with Dentifrice, Procedure: Turmeric MassagingSRP with turmeric massaging on half arch |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth Brushing with DentifriceTooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste). | Procedure or surgery | SRP with turmeric massaging, Turmeric massaging |
| Turmeric Massaging:-Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with whole Turmeric Powder. | Procedure or surgery | SRP with turmeric massaging, Tooth Brushing |
| SRP with turmeric massagingon 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 | Procedure or surgery | Tooth Brushing, Turmeric massaging |
Primary outcome
Plaque Index (Turesky modification of Quigley Hein Index, 1970)
Time frame: baseline
24 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Background: PubMed 26447754Izui 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.
- Background: PubMed 25654020Farjana 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.
- Background: PubMed 22554269Zhou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Subhash Garg, MDS study chair
Govt. Dental College, Indore
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.