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Completed

NCT Number: NCT02638740

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

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.

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Key information

Age range

28 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Govt. College of Dentistry Indore, M.P. India

Indore, M.P, 452001, India

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling and Root Planing (SRP)

Procedure

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 SRP

Procedure

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 outcomes

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

    Time frame: Baseline

    2 surfaces of all tooth measured

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Government College of Dentistry, Indore

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2015
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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