History of Changes for Study: NCT02638740

A Clinical Trial to Study the Beneficial Effect of Mustard Oil and Salt Massaging With Oral Prophylaxis in Patients With Gum Diseases

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Study Record Versions

Version	Submitted Date	Changes
1	December 22, 2015	None (earliest Version on record)
2	December 23, 2015	Study Description, Study Design and Study Status
3	January 11, 2016	Recruitment Status, Study Status, Arms and Interventions, Study Design and Study Identification
4	February 12, 2016	Study Status and IPDSharing
5	April 14, 2017	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	GDCIndore
Brief Title:	A Clinical Trial 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
Secondary IDs:

Study Status


Record Verification:	December 2015
Overall Status:	Active, not recruiting
Study Start:	June 2015
Primary Completion:	December 2015 [Anticipated]
Study Completion:	December 2015 [Anticipated]

First Submitted:	December 20, 2015
First Submitted that Met QC Criteria:	December 22, 2015
First Posted:	December 23, 2015 [Estimate]

Last Update Submitted that Met QC Criteria:	December 22, 2015
Last Update Posted:	December 23, 2015 [Estimate]

Sponsor/Collaborators


Sponsor:	Government College of Dentistry, Indore
Responsible Party:	Principal Investigator Investigator: Dr. Trishna Mhapsekar Official Title: Dr. Affiliation: Government College of Dentistry, Indore
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief Summary:

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% population1. 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.2 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 health3, lowers triglyceride4, prevents obesity4. Massage with mustard oil relieves rheumatism5,6 and arthritis5,6, 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 cancer7, 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 action8.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.

Conditions


Conditions:	Chronic Periodontitis
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	50 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: SCALING AND ROOT PLANING 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.

Outcome Measures


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

Eligibility


Minimum Age:	28 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
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

Contacts/Locations


Study Officials:	trishna Mhapsekar Principal Investigator Government College of Dentistry, Indore
Locations:	India, M.P
	Govt. College of Dentistry Indore, M.P. India Indore, M.P, India, 452001

IPDSharing


Plan to Share IPD:

References


Citations:	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. PubMed 21597673
	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. PubMed 25210256
	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. PubMed 6939833
Links:
Available IPD/Information: