Chronic PeriodontitisNCT02638740
To Study the Beneficial Effect of Mustard Oil and Salt Massaging With Oral Prophylaxis in Patients With Gum Diseases
A study testing SCALING AND ROOT PLANING (SRP) and MUSTARD OIL AND SALT MASSAGE WITH SRP in people with Chronic Periodontitis, run by Government College of Dentistry, Indore at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 65 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- SCALING AND ROOT PLANING (SRP) and MUSTARD OIL AND SALT MASSAGE WITH SRP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with moderate to severe Chronic Generalized Periodontitis
- Not undergone any major periodontal treatment in past 6 months
- Otherwise clinically healthy patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- SCALING AND ROOT PLANING (SRP), MUSTARD OIL AND SALT MASSAGE WITH SRP
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCALING AND ROOT PLANING (SRP)Procedure or surgery
Scaling and root planning done with ultrasonic scalar with reinforcement of oral hygiene measures and follow up for 90 days.
MUSTARD OIL AND SALT MASSAGE WITH SRPProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| SCALING AND ROOT PLANING (SRP) | Active comparator | Scaling and root planning with ultrasonic scalar Receives: Procedure: SCALING AND ROOT PLANING (SRP) |
| MUSTARD OIL AND SALT MASSAGE WITH SRP | Experimental | 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. Receives: Procedure: SCALING AND ROOT PLANING (SRP); Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
2 surfaces of all tooth measured
Measured: Baseline
Secondary outcomes (31)
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
2 surface of each tooth measured
Measured: 1 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
2 surface of each tooth measured
Measured: 2 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
2 surface of each tooth measured
Measured: 4 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
2 surface of each tooth measured
Measured: 8 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
2 surface of each tooth measured
Measured: 12 week
Probing pocket depth (PPD)
6 surface of each tooth measured
Measured: Baseline
Probing pocket depth (PPD)
6 surface of each tooth measured
Measured: 1 week
Probing pocket depth (PPD)
6 surface of each tooth measured
Measured: 2 week
Probing pocket depth (PPD)
6 surface of each tooth measured
Measured: 4 week
Probing pocket depth (PPD)
6 surface of each tooth measured
Measured: 8 week
Probing pocket depth (PPD)
6 surface of each tooth measured
Measured: 12 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
4 sites of all tooth measured
Measured: Baseline
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
4 sites of all tooth measured
Measured: 1 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
4 sites of all tooth measured
Measured: 2 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
4 sites of all tooth measured
Measured: 4 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
4 sites of all tooth measured
Measured: 8 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
4 sites of all tooth measured
Measured: 12 week
Clinical Attachment Level (CAL)
6 surfaces of each teeth measured
Measured: Baseline
Clinical Attachment Level (CAL)
6 surfaces of each teeth measured
Measured: 1 week
Clinical Attachment Level (CAL)
6 surfaces of each teeth measured
Measured: 2 week
Clinical Attachment Level (CAL)
6 surfaces of each teeth measured
Measured: 4 week
Clinical Attachment Level (CAL)
6 surfaces of each teeth measured
Measured: 8 week
Clinical Attachment Level (CAL)
6 surfaces of each teeth measured
Measured: 12 week
Mobility Index (S.C Miller 1974)
Mobility of each tooth measured
Measured: Baseline
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Interdental papilla of each teeth in checked
Measured: Baseline
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Interdental papilla of each teeth in checked
Measured: 1 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Interdental papilla of each teeth in checked
Measured: 2 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Interdental papilla of each teeth in checked
Measured: 4 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Interdental papilla of each teeth in checked
Measured: 8 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Interdental papilla of each teeth in checked
Measured: 12 week
Russels Periodontal Index
Each tooth measure
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government College of Dentistry, Indore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Trishna Mhapsekar, Government College of Dentistry, Indore
- Investigators
- trishna Mhapsekar, Principal investigator, Government College of Dentistry, Indore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638740
- Sponsor's protocol ID
- GDCIndore
- Status last verified
- Apr 2017
- First submitted
- 20 Dec 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 21597673Singla 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 25210256Fourel 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02638740
- Acronym / sponsor ID
- GDCIndore
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Government College of Dentistry, IndoreUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCALING AND ROOT PLANING (SRP) | Active comparator | Procedure: SCALING AND ROOT PLANING (SRP)Scaling and root planning with ultrasonic scalar |
| MUSTARD OIL AND SALT MASSAGE WITH SRP | Experimental | Procedure: SCALING AND ROOT PLANING (SRP), Procedure: MUSTARD OIL AND SALT MASSAGE WITH SRPScaling 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. |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with moderate to severe Chronic Generalized Periodontitis
- Not undergone any major periodontal treatment in past 6 months
- Otherwise clinically healthy patients
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | MUSTARD OIL AND SALT MASSAGE WITH SRP, SCALING AND ROOT PLANING (SRP) |
| MUSTARD OIL AND SALT MASSAGE WITH SRPScaling 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 or surgery | MUSTARD OIL AND SALT MASSAGE WITH SRP |
Primary outcome
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Time frame: Baseline
2 surfaces of all tooth measured
31 secondary outcomes
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Time frame: 1 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Time frame: 2 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Time frame: 4 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Time frame: 8 week
Plaque Index (Turesky modification of Quigely Hein Index, 1970)
Time frame: 12 week
Probing pocket depth (PPD)
Time frame: Baseline
Probing pocket depth (PPD)
Time frame: 1 week
Probing pocket depth (PPD)
Time frame: 2 week
Probing pocket depth (PPD)
Time frame: 4 week
Probing pocket depth (PPD)
Time frame: 8 week
Probing pocket depth (PPD)
Time frame: 12 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Time frame: Baseline
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Time frame: 1 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Time frame: 2 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Time frame: 4 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Time frame: 8 week
Modified Gingival Index (Lobene, Weather, Ford, Ross, Lamm, 1986)
Time frame: 12 week
Clinical Attachment Level (CAL)
Time frame: Baseline
Clinical Attachment Level (CAL)
Time frame: 1 week
Clinical Attachment Level (CAL)
Time frame: 2 week
Clinical Attachment Level (CAL)
Time frame: 4 week
Clinical Attachment Level (CAL)
Time frame: 8 week
Clinical Attachment Level (CAL)
Time frame: 12 week
Mobility Index (S.C Miller 1974)
Time frame: Baseline
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Time frame: Baseline
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Time frame: 1 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Time frame: 2 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Time frame: 4 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Time frame: 8 week
Papillary Bleeding Index (Saxer and Muhlemann, 1975)
Time frame: 12 week
Russels Periodontal Index
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Background: PubMed 21597673Quist 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.
- Background: PubMed 25210256Singla 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.
- Background: PubMed 6939833Fourel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
trishna Mhapsekar principal investigator
Government College of Dentistry, Indore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCALING AND ROOT PLANING (SRP) and MUSTARD OIL AND SALT MASSAGE WITH SRP in people with Chronic Periodontitis, run by Government College of Dentistry, Indore at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (Turesky modification of Quigely Hein Index, 1970) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02638740, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.