Clinical trial NCT02638740: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Government College of Dentistry, Indore
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 54
Sex: ALL
Minimum age (years): 28
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plaque Index (Turesky modification of Quigely Hein Index, 1970)
timeFrame: Baseline
Secondary outcomes:
measure: Plaque Index (Turesky modification of Quigely Hein Index, 1970)
timeFrame: 1 week
measure: Plaque Index (Turesky modification of Quigely Hein Index, 1970)
timeFrame: 2 week
measure: Plaque Index (Turesky modification of Quigely Hein Index, 1970)
timeFrame: 4 week
measure: Plaque Index (Turesky modification of Quigely Hein Index, 1970)
timeFrame: 8 week
measure: Plaque Index (Turesky modification of Quigely Hein Index, 1970)
timeFrame: 12 week
measure: Probing pocket depth (PPD)
timeFrame: Baseline
measure: Probing pocket depth (PPD)
timeFrame: 1 week
measure: Probing pocket depth (PPD)
timeFrame: 2 week
measure: Probing pocket depth (PPD)
timeFrame: 4 week
measure: Probing pocket depth (PPD)
timeFrame: 8 week
measure: Probing pocket depth (PPD)
timeFrame: 12 week
measure: Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
timeFrame: Baseline
measure: Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
timeFrame: 1 week
measure: Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
timeFrame: 2 week
measure: Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
timeFrame: 4 week
measure: Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
timeFrame: 8 week
measure: Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
timeFrame: 12 week
measure: Clinical Attachment Level (CAL)
timeFrame: Baseline
measure: Clinical Attachment Level (CAL)
timeFrame: 1 week
measure: Clinical Attachment Level (CAL)
timeFrame: 2 week
measure: Clinical Attachment Level (CAL)
timeFrame: 4 week
measure: Clinical Attachment Level (CAL)
timeFrame: 8 week
measure: Clinical Attachment Level (CAL)
timeFrame: 12 week
measure: Mobility Index (S.C Miller 1974)
timeFrame: Baseline
measure: Papillary Bleeding Index (Saxer and Muhlemann, 1975)
timeFrame: Baseline
measure: Papillary Bleeding Index (Saxer and Muhlemann, 1975)
timeFrame: 1 week
measure: Papillary Bleeding Index (Saxer and Muhlemann, 1975)
timeFrame: 2 week
measure: Papillary Bleeding Index (Saxer and Muhlemann, 1975)
timeFrame: 4 week
measure: Papillary Bleeding Index (Saxer and Muhlemann, 1975)
timeFrame: 8 week
measure: Papillary Bleeding Index (Saxer and Muhlemann, 1975)
timeFrame: 12 week
measure: Russels Periodontal Index
timeFrame: Baseline
Other outcomes:
Locations:
city: Indore
country: India
facility: Govt. College of Dentistry Indore, M.P. India
state: M.P
Study officials:
affiliation: Government College of Dentistry, Indore
name: trishna Mhapsekar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.