GingivitisNCT02546804
A Clinical Trial to Study the Effects of Two Home Made Mouthwashes in Patients With Gum Diseases
A study testing HOT SALT WATER, POTASSIUM PERMANGANATE and CHLORHEXIDINE in people with Gingivitis and Periodontitis, run by Government College of Dentistry, Indore at 1 site in India.
Trial summary
Periodontal Disease is a ubiquitous in nature affecting about 80% population of India. The Periodontal Disease is a multifactorial but the dental plaque is considered as main etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in between teeth, if not removed by effective daily… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- HOT SALT WATER, POTASSIUM PERMANGANATE and CHLORHEXIDINE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject of Chronic Generalized Gingivitis and Mild Generalized Periodontitis.
- Not undergone any major periodontal treatment earlier in last 06 months .
- Otherwise Clinically Healthy Patient.
Who cannot join
- Subjects with significant systemic diseases (e.g. Diabetes Mellitus, Cancer or Coronary heart disease etc.).
- Pregnant or lactating women.
- Smoker.
- Patients on anti-inflammatory drugs or antibiotics
- Patients allergic to any material used for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Efficacy of Potassium Permanganate Mouthwash and Hot Salt Water Mouthwash and Their Comparison With Chlorhexidine Mouthwash on Plaque Index,Gingival Index and Periodontal Probing Depth
Periodontal Disease is a ubiquitous in nature affecting about 80% population of India. The Periodontal Disease is a multifactorial but the dental plaque is considered as main etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in between teeth, if not removed by effective daily brushing and flossing, plaque can cause Gum infection and tooth loss. Though, many scientific periodontal procedures are available to get the treatment but because of lack of man power and poor socioeconomic condition it is not possible for every group of population in our India.
Read the detailed description
The need exist for continued research to find the use of home made mouthwashes in preventing periodontal diseases. Although, Chlorhexidine mouthwash is regarded as Gold standard mouthwash as antiplaque but have some limitations like cost factor and side effects like staining of teeth, loss of taste, oral mucosal ulcerations,paresthesia and may enhanced supragingival calculus formation. Use of various indigenous products and home made preparations are easily available and are being used since ancient time in India and still in practice in various parts of India especially rural and remote areas.
At the same time the use of potassium permanganate is still in practice in various parts of India and also it was in practice before the availability of Chlorhexidine, povidone iodine and other antiseptic solutions, as they are used since about 30 years only. Use of hot salt water rinsing is in practice especially to reduce the symptoms of various throat infections such as pharyngitis, tonsillitis and also to improve oral hygiene.It is also being used in oral surgery and their effects are also mention in literature.
Hence, the aim of this study is to assess and compare the efficacy of home made remedies like hot salt water and potassium permanganate as a mouthwash in reducing Plaque accumulation and improving Gingival conditions with Gold standard Chlorhexidine mouthwash if found effective may be used as affordable mouthwash for the benefit of population of India.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- HOT SALT WATER, POTASSIUM PERMANGANATE, CHLORHEXIDINE
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOT SALT WATERProcedure or surgery
25ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.
POTASSIUM PERMANGANATEProcedure or surgery
10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.
CHLORHEXIDINEProcedure or surgery
10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.
| Study group | Role | What they receive |
|---|---|---|
| HOT SALT WATER | Experimental | 3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days. Receives: Procedure: HOT SALT WATER |
| POTASSIUM PERMANGANATE | Experimental | 0.01% POTASSIUM PERMANGANATE, 10ml used for rinsing for 60 sec, twice daily for 60 days. Receives: Procedure: POTASSIUM PERMANGANATE |
| CHLORHEXIDINE | Active comparator | 0.2% CHLORHEXIDINE, 10ml used for rinsing for 60 sec, twice daily for 60 days. Receives: Procedure: CHLORHEXIDINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
4 sites of all tooth is observed
Measured: baseline
Secondary outcomes (14)
Plaque Index
4 sites of all tooth is observed
Measured: 2weeks
Plaque Index
4 sites of all tooth is observed
Measured: 4weeks
Plaque Index
4 sites of all tooth is observed
Measured: 6weeks
Plaque Index
4 sites of all tooth is observed
Measured: 8weeks
Gingival Index
4 sites of all tooth is observed
Measured: baseline
Gingival Index
4 sites of all tooth is observed
Measured: 2weeks
Gingival Index
4 sites of all tooth is observed
Measured: 4weeks
Gingival Index
4 sites of all tooth is observed
Measured: 6weeks
Gingival Index
4 sites of all tooth is observed
Measured: 8weeks
Periodontal Probing Depth
6 sites of all tooth is observed
Measured: baseline
Periodontal Probing Depth
6 sites of all tooth is observed
Measured: 2weeks
Periodontal Probing Depth
6 sites of all tooth is observed
Measured: 4weeks
Periodontal Probing Depth
6 sites of all tooth is observed
Measured: 6weeks
Periodontal Probing Depth
6 sites of all tooth is observed
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government College of Dentistry, Indore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agrima Singh, Government College of Dentistry, Indore
- Investigators
- agrima singh, Principal investigator, Government College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546804
- Sponsor's protocol ID
- GCDIndore
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2015
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Resende MM, Rocha CA, Correa NF, Veiga RR, Passos SJ, Novo NF, Juliano Y, Damasceno CA. Tap water versus sterile saline solution in the colonisation of skin wounds. Int Wound J. 2016 Aug;13(4):526-30. doi: 10.1111/iwj.12470. Epub 2015 Jun 8.
PubMed 26059709Supranoto SC, Slot DE, Addy M, Van der Weijden GA. The effect of chlorhexidine dentifrice or gel versus chlorhexidine mouthwash on plaque, gingivitis, bleeding and tooth discoloration: a systematic review. Int J Dent Hyg. 2015 May;13(2):83-92. doi: 10.1111/idh.12078. Epub 2014 Jul 24.
PubMed 25059640
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy of Potassium Permanganate Mouthwash and Hot Salt Water Mouthwash and Their Comparison With Chlorhexidine Mouthwash on Plaque Index,Gingival Index and Periodontal Probing Depth
- ClinicalTrials.gov ID
- NCT02546804
- Acronym / sponsor ID
- GCDIndore
- Conditions
- Gingivitis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Government College of Dentistry, IndoreUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Sep 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 ubiquitous in nature affecting about 80% population of India. The Periodontal Disease is a multifactorial but the dental plaque is considered as main etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in between teeth, if not removed by effective daily brushing and flossing, plaque can cause Gum infection and tooth loss. Though, many scientific periodontal procedures are available to get the treatment but because of lack of man power and poor socioeconomic condition it is not possible for every group of population in our India.
Detailed description
The need exist for continued research to find the use of home made mouthwashes in preventing periodontal diseases. Although, Chlorhexidine mouthwash is regarded as Gold standard mouthwash as antiplaque but have some limitations like cost factor and side effects like staining of teeth, loss of taste, oral mucosal ulcerations,paresthesia and may enhanced supragingival calculus formation. Use of various indigenous products and home made preparations are easily available and are being used since ancient time in India and still in practice in various parts of India especially rural and remote areas.
At the same time the use of potassium permanganate is still in practice in various parts of India and also it was in practice before the availability of Chlorhexidine, povidone iodine and other antiseptic solutions, as they are used since about 30 years only. Use of hot salt water rinsing is in practice especially to reduce the symptoms of various throat infections such as pharyngitis, tonsillitis and also to improve oral hygiene.It is also being used in oral surgery and their effects are also mention in literature.
Hence, the aim of this study is to assess and compare the efficacy of home made remedies like hot salt water and potassium permanganate as a mouthwash in reducing Plaque accumulation and improving Gingival conditions with Gold standard Chlorhexidine mouthwash if found effective may be used as affordable mouthwash for the benefit of population of India.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HOT SALT WATER | Experimental | Procedure: HOT SALT WATER3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days. |
| POTASSIUM PERMANGANATE | Experimental | Procedure: POTASSIUM PERMANGANATE0.01% POTASSIUM PERMANGANATE, 10ml used for rinsing for 60 sec, twice daily for 60 days. |
| CHLORHEXIDINE | Active comparator | Procedure: CHLORHEXIDINE0.2% CHLORHEXIDINE, 10ml used for rinsing for 60 sec, twice daily for 60 days. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject of Chronic Generalized Gingivitis and Mild Generalized Periodontitis.
- Not undergone any major periodontal treatment earlier in last 06 months .
- Otherwise Clinically Healthy Patient.
Key exclusion criteria (5 listed)
- Subjects with significant systemic diseases (e.g. Diabetes Mellitus, Cancer or Coronary heart disease etc.).
- Pregnant or lactating women.
- Smoker.
- Patients on anti-inflammatory drugs or antibiotics
- Patients allergic to any material used for the study
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 |
|---|---|---|
| HOT SALT WATER25ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks. | Procedure or surgery | HOT SALT WATER |
| POTASSIUM PERMANGANATE10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks. | Procedure or surgery | POTASSIUM PERMANGANATE |
| CHLORHEXIDINE10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks. | Procedure or surgery | CHLORHEXIDINE |
Primary outcome
Plaque Index
Time frame: baseline
4 sites of all tooth is observed
14 secondary outcomes
Plaque Index
Time frame: 2weeks
Plaque Index
Time frame: 4weeks
Plaque Index
Time frame: 6weeks
Plaque Index
Time frame: 8weeks
Gingival Index
Time frame: baseline
Gingival Index
Time frame: 2weeks
Gingival Index
Time frame: 4weeks
Gingival Index
Time frame: 6weeks
Gingival Index
Time frame: 8weeks
Periodontal Probing Depth
Time frame: baseline
Periodontal Probing Depth
Time frame: 2weeks
Periodontal Probing Depth
Time frame: 4weeks
Periodontal Probing Depth
Time frame: 6weeks
Periodontal Probing Depth
Time frame: 8weeks
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 6 Aug 2018.
- Background: PubMed 26059709Resende MM, Rocha CA, Correa NF, Veiga RR, Passos SJ, Novo NF, Juliano Y, Damasceno CA. Tap water versus sterile saline solution in the colonisation of skin wounds. Int Wound J. 2016 Aug;13(4):526-30. doi: 10.1111/iwj.12470. Epub 2015 Jun 8.
- Background: PubMed 25059640Supranoto SC, Slot DE, Addy M, Van der Weijden GA. The effect of chlorhexidine dentifrice or gel versus chlorhexidine mouthwash on plaque, gingivitis, bleeding and tooth discoloration: a systematic review. Int J Dent Hyg. 2015 May;13(2):83-92. doi: 10.1111/idh.12078. Epub 2014 Jul 24.
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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.
agrima singh principal investigator
Government College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOT SALT WATER, POTASSIUM PERMANGANATE and CHLORHEXIDINE in people with Gingivitis and 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 5 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 6 Aug 2018. 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 (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 NCT02546804, which also lists 2 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 6 Aug 2018.