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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SCALING AND ROOT PLANING (SRP)
MUSTARD OIL AND SALT MASSAGE WITH SRP
Sponsored by
Government College of Dentistry, Indore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

28 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SCALING AND ROOT PLANING (SRP)

MUSTARD OIL AND SALT MASSAGE WITH SRP

Arm Description

Scaling and root planning with ultrasonic scalar

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.

Outcomes

Primary Outcome Measures

Plaque Index (Turesky modification of Quigely Hein Index, 1970)
2 surfaces of all tooth measured

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2015
Last Updated
April 14, 2017
Sponsor
Government College of Dentistry, Indore
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1. Study Identification

Unique Protocol Identification Number
NCT02638740
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government College of Dentistry, Indore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCALING AND ROOT PLANING (SRP)
Arm Type
Active Comparator
Arm Description
Scaling and root planning with ultrasonic scalar
Arm Title
MUSTARD OIL AND SALT MASSAGE WITH SRP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
SCALING AND ROOT PLANING (SRP)
Intervention Description
Scaling and root planning done with ultrasonic scalar with reinforcement of oral hygiene measures and follow up for 90 days.
Intervention Type
Procedure
Intervention Name(s)
MUSTARD OIL AND SALT MASSAGE WITH SRP
Intervention Description
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 Outcome Measure Information:
Title
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Description
2 surfaces of all tooth measured
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Description
2 surface of each tooth measured
Time Frame
1 week
Title
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Description
2 surface of each tooth measured
Time Frame
2 week
Title
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Description
2 surface of each tooth measured
Time Frame
4 week
Title
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Description
2 surface of each tooth measured
Time Frame
8 week
Title
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Description
2 surface of each tooth measured
Time Frame
12 week
Title
Probing pocket depth (PPD)
Description
6 surface of each tooth measured
Time Frame
Baseline
Title
Probing pocket depth (PPD)
Description
6 surface of each tooth measured
Time Frame
1 week
Title
Probing pocket depth (PPD)
Description
6 surface of each tooth measured
Time Frame
2 week
Title
Probing pocket depth (PPD)
Description
6 surface of each tooth measured
Time Frame
4 week
Title
Probing pocket depth (PPD)
Description
6 surface of each tooth measured
Time Frame
8 week
Title
Probing pocket depth (PPD)
Description
6 surface of each tooth measured
Time Frame
12 week
Title
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Description
4 sites of all tooth measured
Time Frame
Baseline
Title
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Description
4 sites of all tooth measured
Time Frame
1 week
Title
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Description
4 sites of all tooth measured
Time Frame
2 week
Title
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Description
4 sites of all tooth measured
Time Frame
4 week
Title
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Description
4 sites of all tooth measured
Time Frame
8 week
Title
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Description
4 sites of all tooth measured
Time Frame
12 week
Title
Clinical Attachment Level (CAL)
Description
6 surfaces of each teeth measured
Time Frame
Baseline
Title
Clinical Attachment Level (CAL)
Description
6 surfaces of each teeth measured
Time Frame
1 week
Title
Clinical Attachment Level (CAL)
Description
6 surfaces of each teeth measured
Time Frame
2 week
Title
Clinical Attachment Level (CAL)
Description
6 surfaces of each teeth measured
Time Frame
4 week
Title
Clinical Attachment Level (CAL)
Description
6 surfaces of each teeth measured
Time Frame
8 week
Title
Clinical Attachment Level (CAL)
Description
6 surfaces of each teeth measured
Time Frame
12 week
Title
Mobility Index (S.C Miller 1974)
Description
Mobility of each tooth measured
Time Frame
Baseline
Title
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Description
Interdental papilla of each teeth in checked
Time Frame
Baseline
Title
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Description
Interdental papilla of each teeth in checked
Time Frame
1 week
Title
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Description
Interdental papilla of each teeth in checked
Time Frame
2 week
Title
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Description
Interdental papilla of each teeth in checked
Time Frame
4 week
Title
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Description
Interdental papilla of each teeth in checked
Time Frame
8 week
Title
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Description
Interdental papilla of each teeth in checked
Time Frame
12 week
Title
Russels Periodontal Index
Description
Each tooth measure
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
trishna Mhapsekar
Organizational Affiliation
Government College of Dentistry, Indore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Govt. College of Dentistry Indore, M.P. India
City
Indore
State/Province
M.P
ZIP/Postal Code
452001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21597673
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.
Results Reference
background
PubMed Identifier
25210256
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.
Results Reference
background
PubMed Identifier
6939833
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.
Results Reference
background

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

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