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

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ClinicalTrials.gov Identifier: NCT02638740
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Trishna Mhapsekar, Government College of Dentistry, Indore

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: SCALING AND ROOT PLANING (SRP) Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRP Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease Sodium
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: SCALING AND ROOT PLANING (SRP)
Scaling and root planning with ultrasonic scalar
Procedure: SCALING AND ROOT PLANING (SRP)
Scaling and root planning done with ultrasonic scalar with reinforcement of oral hygiene measures and follow up for 90 days.
Experimental: MUSTARD OIL AND SALT MASSAGE WITH SRP
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.
Procedure: SCALING AND ROOT PLANING (SRP)
Scaling and root planning done with ultrasonic scalar with reinforcement of oral hygiene measures and follow up for 90 days.
Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRP
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.



Primary Outcome Measures :
  1. Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: Baseline ]
    2 surfaces of all tooth measured


Secondary Outcome Measures :
  1. Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 1 week ]
    2 surface of each tooth measured

  2. Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 2 week ]
    2 surface of each tooth measured

  3. Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 4 week ]
    2 surface of each tooth measured

  4. Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 8 week ]
    2 surface of each tooth measured

  5. Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 12 week ]
    2 surface of each tooth measured

  6. Probing pocket depth (PPD) [ Time Frame: Baseline ]
    6 surface of each tooth measured

  7. Probing pocket depth (PPD) [ Time Frame: 1 week ]
    6 surface of each tooth measured

  8. Probing pocket depth (PPD) [ Time Frame: 2 week ]
    6 surface of each tooth measured

  9. Probing pocket depth (PPD) [ Time Frame: 4 week ]
    6 surface of each tooth measured

  10. Probing pocket depth (PPD) [ Time Frame: 8 week ]
    6 surface of each tooth measured

  11. Probing pocket depth (PPD) [ Time Frame: 12 week ]
    6 surface of each tooth measured

  12. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: Baseline ]
    4 sites of all tooth measured

  13. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 1 week ]
    4 sites of all tooth measured

  14. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 2 week ]
    4 sites of all tooth measured

  15. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 4 week ]
    4 sites of all tooth measured

  16. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 8 week ]
    4 sites of all tooth measured

  17. Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 12 week ]
    4 sites of all tooth measured

  18. Clinical Attachment Level (CAL) [ Time Frame: Baseline ]
    6 surfaces of each teeth measured

  19. Clinical Attachment Level (CAL) [ Time Frame: 1 week ]
    6 surfaces of each teeth measured

  20. Clinical Attachment Level (CAL) [ Time Frame: 2 week ]
    6 surfaces of each teeth measured

  21. Clinical Attachment Level (CAL) [ Time Frame: 4 week ]
    6 surfaces of each teeth measured

  22. Clinical Attachment Level (CAL) [ Time Frame: 8 week ]
    6 surfaces of each teeth measured

  23. Clinical Attachment Level (CAL) [ Time Frame: 12 week ]
    6 surfaces of each teeth measured

  24. Mobility Index (S.C Miller 1974) [ Time Frame: Baseline ]
    Mobility of each tooth measured

  25. Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: Baseline ]
    Interdental papilla of each teeth in checked

  26. Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 1 week ]
    Interdental papilla of each teeth in checked

  27. Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 2 week ]
    Interdental papilla of each teeth in checked

  28. Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 4 week ]
    Interdental papilla of each teeth in checked

  29. Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 8 week ]
    Interdental papilla of each teeth in checked

  30. Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 12 week ]
    Interdental papilla of each teeth in checked

  31. Russels Periodontal Index [ Time Frame: Baseline ]
    Each tooth measure



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Ages Eligible for Study:   28 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638740


Locations
India
Govt. College of Dentistry Indore, M.P. India
Indore, M.P, India, 452001
Sponsors and Collaborators
Government College of Dentistry, Indore
Investigators
Principal Investigator: trishna Mhapsekar Government College of Dentistry, Indore

Publications:
Responsible Party: Dr. Trishna Mhapsekar, Dr., Government College of Dentistry, Indore
ClinicalTrials.gov Identifier: NCT02638740     History of Changes
Other Study ID Numbers: GDCIndore
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Mechlorethamine
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents