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

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

Tracking Information

• First Submitted Date: December 20, 2015
• First Posted Date: December 23, 2015
• Last Update Posted Date: April 18, 2017
• Study Start Date: June 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2015)

Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: Baseline ]

2 surfaces of all tooth measured

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 22, 2015)

• Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 1 week ]
  2 surface of each tooth measured
• Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 2 week ]
  2 surface of each tooth measured
• Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 4 week ]
  2 surface of each tooth measured
• Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 8 week ]
  2 surface of each tooth measured
• Plaque Index (Turesky modification of Quigely Hein Index, 1970) [ Time Frame: 12 week ]
  2 surface of each tooth measured
• Probing pocket depth (PPD) [ Time Frame: Baseline ]
  6 surface of each tooth measured
• Probing pocket depth (PPD) [ Time Frame: 1 week ]
  6 surface of each tooth measured
• Probing pocket depth (PPD) [ Time Frame: 2 week ]
  6 surface of each tooth measured
• Probing pocket depth (PPD) [ Time Frame: 4 week ]
  6 surface of each tooth measured
• Probing pocket depth (PPD) [ Time Frame: 8 week ]
  6 surface of each tooth measured
• Probing pocket depth (PPD) [ Time Frame: 12 week ]
  6 surface of each tooth measured
• Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: Baseline ]
  4 sites of all tooth measured
• Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 1 week ]
  4 sites of all tooth measured
• Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 2 week ]
  4 sites of all tooth measured
• Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 4 week ]
  4 sites of all tooth measured
• Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 8 week ]
  4 sites of all tooth measured
• Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986) [ Time Frame: 12 week ]
  4 sites of all tooth measured
• Clinical Attachment Level (CAL) [ Time Frame: Baseline ]
  6 surfaces of each teeth measured
• Clinical Attachment Level (CAL) [ Time Frame: 1 week ]
  6 surfaces of each teeth measured
• Clinical Attachment Level (CAL) [ Time Frame: 2 week ]
  6 surfaces of each teeth measured
• Clinical Attachment Level (CAL) [ Time Frame: 4 week ]
  6 surfaces of each teeth measured
• Clinical Attachment Level (CAL) [ Time Frame: 8 week ]
  6 surfaces of each teeth measured
• Clinical Attachment Level (CAL) [ Time Frame: 12 week ]
  6 surfaces of each teeth measured
• Mobility Index (S.C Miller 1974) [ Time Frame: Baseline ]
  Mobility of each tooth measured
• Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: Baseline ]
  Interdental papilla of each teeth in checked
• Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 1 week ]
  Interdental papilla of each teeth in checked
• Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 2 week ]
  Interdental papilla of each teeth in checked
• Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 4 week ]
  Interdental papilla of each teeth in checked
• Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 8 week ]
  Interdental papilla of each teeth in checked
• Papillary Bleeding Index (Saxer and Muhlemann, 1975) [ Time Frame: 12 week ]
  Interdental papilla of each teeth in checked
• Russels Periodontal Index [ Time Frame: Baseline ]
  Each tooth measure

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Study the Beneficial Effect of Mustard Oil and Salt Massaging With Oral Prophylaxis in Patients With Gum Diseases
• 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
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Periodontitis

Intervention

• 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.

Study Arms

• Active Comparator: SCALING AND ROOT PLANING (SRP)
  Scaling and root planning with ultrasonic scalar
  Intervention: Procedure: SCALING AND ROOT PLANING (SRP)
• 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.
  Interventions:

  • Procedure: SCALING AND ROOT PLANING (SRP)
  • Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRP

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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 11, 2016): 54
• Original Estimated Enrollment (submitted: December 22, 2015): 50
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 28 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02638740
• Other Study ID Numbers: GDCIndore
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Dr. Trishna Mhapsekar, Government College of Dentistry, Indore
• Original Responsible Party: Same as current
• Current Study Sponsor: Government College of Dentistry, Indore
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: trishna Mhapsekar; Government College of Dentistry, Indore

• PRS Account: Government College of Dentistry, Indore
• Verification Date: April 2017