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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: SCALING AND ROOT PLANING (SRP); Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRP

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
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • M.P
    • Indore, M.P, India, 452001
      • Govt. College of Dentistry Indore, M.P. India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index (Turesky modification of Quigely Hein Index, 1970)	2 surfaces of all tooth measured	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 20, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Mechlorethamine
• Other Study ID Numbers: GDCIndore

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided