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AzTrials

Chronic PeriodontitisNCT02638740

To Study the Beneficial Effect of Mustard Oil and Salt Massaging With Oral Prophylaxis in Patients With Gum Diseases

A study testing SCALING AND ROOT PLANING (SRP) and MUSTARD OIL AND SALT MASSAGE WITH SRP in people with Chronic Periodontitis, run by Government College of Dentistry, Indore at 1 site in India.

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 a chronic inflammatory process accompanied by destruction of Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially in developing and underdeveloped countries affecting more than 80% population. Read more about this study

Who is it for?
Ages 28 to 65 years
Conditions the study is for
Chronic Periodontitis
What is being tested?
SCALING AND ROOT PLANING (SRP) and MUSTARD OIL AND SALT MASSAGE WITH SRP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteIndia
Study dates
Jun 2015to Dec 2015
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 28 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with moderate to severe Chronic Generalized Periodontitis
  • Not undergone any major periodontal treatment in past 6 months
  • Otherwise clinically healthy patients

Who cannot join

  • Any known systemic diseases specially Diabetes and other major diseases.
  • Patients on anti-inflammatory drugs or antibiotics
  • Patient allergic to any material used for the study
  • Pregnant and lactating mothers
  • Periodontal therapy in past 6 months
  • Smoker and tobacco chewer

Trial locations and contacts

1 site in 1 country.

India1 site
  • Govt. College of Dentistry Indore, M.P. India

    Indore, M.P, 452001

Other trials in India

About this study

Official title: To Assess the Efficacy of Mustard Oil and Salt Massage as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis: A Clinical Study

Periodontal disease is a chronic inflammatory process accompanied by destruction of Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially in developing and underdeveloped countries affecting more than 80% population. Epidemiological studies have shown that about 10% of the adult population suffer from severe periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion is not strictly a localized process but may lead to systemic alterations in immune system. Various studies confirm the microbial etiology of periodontal disease.

Read the detailed description

Periodontal disease is a chronic inflammatory process accompanied by destruction of Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially in developing and underdeveloped countries affecting more than 80% population. Epidemiological studies have shown that about 10% of the adult population suffer from severe periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion is not strictly a localized process but may lead to systemic alterations in immune system. Various studies confirm the microbial etiology of periodontal disease. The bacteria that cause periodontitis include mainly diversity of anerobic bacteria; Porphyromonas Gingivalis, Fusobacterium Nucleatum, Peptostreptococcus, Prevotella species being the most significant.

Various therapeutic approaches are available for treatment of this disease utilizing non surgical and surgical methods, but the treatment is still challenging for the clinician and cumbersome for the patients. In many cases of moderate to severe chronic periodontitis anti- inflammatory and antibiotics are used as an adjunct. Systemic antibiotic agents may reduce or eliminate microbes that cannot be removed by Scaling and Root Planing. This includes microbes that have penetrated tissues or root surfaces which may act as reservoir for recolonization. However synthetic antibiotics and anti-inflammatory agents result in complications like drug resistance, gastrointestinal complications, congestive heart failures and renal failures and other complications.

Especially in India Mustard Oil and Salt is long being used for gum massage and for maintenance and improvement of Oral Hygiene. As this practice of using homemade formulation is beneficial for Gingival and Periodontal health, economic and free from any major side effects it should be studied to document its efficacy as an adjunct to Scaling and Root Planing. Mustard oil is considered to have low saturated fat. The monounsaturated fatty acids and proper ratio of polyunsaturated fatty acids improve heart health, lowers triglyceride, prevents obesity. Massage with mustard oil relieves rheumatism and arthritis, sprains and aches. The selenium present in the oil reduces effects of asthma and joint pain. High level of Vit. E improves skin health and impart protection against UV rays. Mustard seeds are effective in gastrointestinal and colorectal cancer, as mustard is rich in glucosinolate and phytonutrients. It is effective in curing cold, cough, body pains \& aches. Salt in topical formulation is found to have anti inflammatory action.Hence this study aims to evaluate this versatile formulation in treatment of Chronic Periodontitis. As the use of Mustard Oil and Salt is practiced by a strata of population in our country thus it is advisable and necessary to assess scientifically the efficacy of mustard oil and salt massage in improving Gingival and Periodontal Health.

Being tested
SCALING AND ROOT PLANING (SRP), MUSTARD OIL AND SALT MASSAGE WITH SRP
Medical subject headings
Chronic Periodontitis

What participants receive

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

  • SCALING AND ROOT PLANING (SRP)Procedure or surgery

    Scaling and root planning done with ultrasonic scalar with reinforcement of oral hygiene measures and follow up for 90 days.

  • MUSTARD OIL AND SALT MASSAGE WITH SRPProcedure or surgery

    Scaling and root planing was done with ultrasonic scalar. It was followed by gum massaging with 0.32gm salt in 5ml mustard oil for 5min, twice daily for 90 days.

Study groups in NCT02638740
Study groupRoleWhat they receive
SCALING AND ROOT PLANING (SRP)Active comparatorScaling and root planning with ultrasonic scalar
Receives: Procedure: SCALING AND ROOT PLANING (SRP)
MUSTARD OIL AND SALT MASSAGE WITH SRPExperimentalScaling and root planing was done with ultrasonic scalar. It was followed by gum massaging with 0.32gm salt in 5ml mustard oil for 5min, twice daily for 90 days.
Receives: Procedure: SCALING AND ROOT PLANING (SRP); Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRP

What is being measured

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

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

    2 surfaces of all tooth measured

    Measured: Baseline

Secondary outcomes (31)
  1. Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    2 surface of each tooth measured

    Measured: 1 week

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

    2 surface of each tooth measured

    Measured: 2 week

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

    2 surface of each tooth measured

    Measured: 4 week

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

    2 surface of each tooth measured

    Measured: 8 week

  5. Plaque Index (Turesky modification of Quigely Hein Index, 1970)

    2 surface of each tooth measured

    Measured: 12 week

  6. Probing pocket depth (PPD)

    6 surface of each tooth measured

    Measured: Baseline

  7. Probing pocket depth (PPD)

    6 surface of each tooth measured

    Measured: 1 week

  8. Probing pocket depth (PPD)

    6 surface of each tooth measured

    Measured: 2 week

  9. Probing pocket depth (PPD)

    6 surface of each tooth measured

    Measured: 4 week

  10. Probing pocket depth (PPD)

    6 surface of each tooth measured

    Measured: 8 week

  11. Probing pocket depth (PPD)

    6 surface of each tooth measured

    Measured: 12 week

  12. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)

    4 sites of all tooth measured

    Measured: Baseline

  13. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)

    4 sites of all tooth measured

    Measured: 1 week

  14. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)

    4 sites of all tooth measured

    Measured: 2 week

  15. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)

    4 sites of all tooth measured

    Measured: 4 week

  16. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)

    4 sites of all tooth measured

    Measured: 8 week

  17. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)

    4 sites of all tooth measured

    Measured: 12 week

  18. Clinical Attachment Level (CAL)

    6 surfaces of each teeth measured

    Measured: Baseline

  19. Clinical Attachment Level (CAL)

    6 surfaces of each teeth measured

    Measured: 1 week

  20. Clinical Attachment Level (CAL)

    6 surfaces of each teeth measured

    Measured: 2 week

  21. Clinical Attachment Level (CAL)

    6 surfaces of each teeth measured

    Measured: 4 week

  22. Clinical Attachment Level (CAL)

    6 surfaces of each teeth measured

    Measured: 8 week

  23. Clinical Attachment Level (CAL)

    6 surfaces of each teeth measured

    Measured: 12 week

  24. Mobility Index (S.C Miller 1974)

    Mobility of each tooth measured

    Measured: Baseline

  25. Papillary Bleeding Index (Saxer and Muhlemann, 1975)

    Interdental papilla of each teeth in checked

    Measured: Baseline

  26. Papillary Bleeding Index (Saxer and Muhlemann, 1975)

    Interdental papilla of each teeth in checked

    Measured: 1 week

  27. Papillary Bleeding Index (Saxer and Muhlemann, 1975)

    Interdental papilla of each teeth in checked

    Measured: 2 week

  28. Papillary Bleeding Index (Saxer and Muhlemann, 1975)

    Interdental papilla of each teeth in checked

    Measured: 4 week

  29. Papillary Bleeding Index (Saxer and Muhlemann, 1975)

    Interdental papilla of each teeth in checked

    Measured: 8 week

  30. Papillary Bleeding Index (Saxer and Muhlemann, 1975)

    Interdental papilla of each teeth in checked

    Measured: 12 week

  31. Russels Periodontal Index

    Each tooth measure

    Measured: Baseline

Timeline

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

  1. First posted23 Dec 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02638740
Sponsor's protocol ID
GDCIndore
Status last verified
Apr 2017
First submitted
20 Dec 2015
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Quist SR, Wiswedel I, Quist J, Gollnick HP. Anti-inflammatory effects of topical formulations containing sea silt and sea salt on human skin in vivo during cutaneous microdialysis. Acta Derm Venereol. 2011 Sep;91(5):597-9. doi: 10.2340/00015555-1128. No abstract available.

    PubMed 21597673
  • Singla N, Acharya S, Martena S, Singla R. Effect of oil gum massage therapy on common pathogenic oral microorganisms - A randomized controlled trial. J Indian Soc Periodontol. 2014 Jul;18(4):441-6. doi: 10.4103/0972-124X.138681.

    PubMed 25210256
  • Fourel J, Falabregues R, Bonfil JJ. A clinical approach to gingival stimulation. J Periodontol. 1981 Mar;52(3):130-4. doi: 10.1902/jop.1981.52.3.130.

    PubMed 6939833

Questions about this trial

What is this clinical trial studying?

A study testing SCALING AND ROOT PLANING (SRP) and MUSTARD OIL AND SALT MASSAGE WITH SRP in people with Chronic Periodontitis, run by Government College of Dentistry, Indore at 1 site in India.

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 3 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Quigely 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 NCT02638740, 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 18 Apr 2017.

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