Periodontal DiseasesNCT03474146
Comparative Evaluation of Antiplaque and Antigingivitis Efficacy of Ocimum Sanctum (Tulsi) Extract
A study testing Ocimum sanctum, Chlorhexidine Gluconate and Propylene Glycol in people with Periodontal Diseases and Gingivitis, run by Government College of Dentistry, Indore at 1 site in India.
Trial summary
Chlorhexidine is considered as gold standard for its antiplaque and antigingivitis efficacy till date but it has got many side effects. So it is need of the hour that investigators will find some substitute having similar antiplque and antigingivitis efficay but have less or no adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Gingivitis, Periodontitis
- What is being tested?
- Ocimum sanctum, Chlorhexidine Gluconate and Propylene Glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 12 Apr 2017to 31 Jul 2017
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cases with generalized chronic gingivitis or cases with mild generalized chronic periodontitis patients of any sex.
- Systemically healthy individuals.
- Participants having >20 teeth.
- Participants in the age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent.
Who cannot join
- Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.
- Participants on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and drugs since 03 months.
- Participants who have known allergy to material used for the study.
- Pregnant and lactating mothers.
- Participants had undergone any kind of nonsurgical and/or surgical periodontal therapy earlier, in past 6 months.
- Tobacco users (smoke and smokeless) and alcoholics.
- Participants wearing any form of intraoral prosthesis or appliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Comparative Evaluation of Antiplaque and Antigingivitis Efficacy of Ocimum Sanctum (Tulsi) Extract Mouthrinse With 0.12% Chlorhexidine Mouthrinse - an in Vitro and in Vivo Study."
Chlorhexidine is considered as gold standard for its antiplaque and antigingivitis efficacy till date but it has got many side effects. So it is need of the hour that investigators will find some substitute having similar antiplque and antigingivitis efficay but have less or no adverse effects. so in this study investigators planned to do "Comparative evaluation of antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with 0.12% chlorhexidine mouthrinse.
Read the detailed description
Title:
"Comparative evaluation of antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with 0.12% chlorhexidine mouthrinse - an in vitro and in vivo study."
Aims And Objectives:
- To evaluate the antimicrobial activity of Ocimum sanctum (Tulsi) extract by Sensitivity testing, Minimum Inhibitory Concentration, Minimum Bactericidal Concentration, and Time kill curve -In Vitro study.
- To evaluate the Antiplaque and Antigingivitis effect of the Ocimum sanctum (Tulsi) by recording Modified Gingival Index and Modified Plaque Index in patients with Chronic Generalized Gingivitis and Mild Chronic Generalized Periodontitis -In Vivo study.
- Clinical evaluation and comparison of the Antiplaque and Antigingivitis effect of the Ocimum sanctum (Tulsi) with 0.12% Chlorhexidine and vehicle.
- To see the topical beneficial and/or harmful side effects of Ocimum sanctum extract, if any.
Study Design:
Prospective randomized controlled Trial- Randomized Comparative Study
Methodology (Material \& Methods):
The present study will have following parts:
- Procurement of extract and formulation of mouthrinse: Ocimum sanctum (Tulsi) extract has been purchased from the ISO (International Organization for Standardization) Certified shop. The desired mouthrinse will be formulated under the guidance of Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.)
- In vitro study: Sensitivity testing, Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC), of Ocimum sanctum will be determined against following microorganisms: Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tannerella forsythia, Pseudomonas aeruginosa, and other microorganisms.
- In vivo study: This study has been planned and would be conducted in the Department of Periodontology, Govt. College of Dentistry, Indore, Madhya pradesh, India. In this study, participants with Chronic Generalized Gingivitis and Mild Chronic Generalized Periodontitis would be randomly selected from outdoor patients. A minimum 90 Recruited participants will be divided into three equal groups randomly. (Parallel design, case control, Randomized Comparative Study).
Group A: (Test group) (n=30) Ocimum sanctum extract as mouthrinse. Group B: (Positive control group) (n=30) 0.12% Chlorhexidine as mouthrinse. Group C: (control group) (n=30) Vehicle as the mouthrinse. All the three solutions would be prepared under the valuable guidance of Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.) and will be kept in coded containers. All the participants in each group would be advised to use their respective mouth rinses twice daily with proper swishing action for a minute, after brushing their teeth (in the morning and before going to bed). To maintain standardization, similar toothbrushes and dentifrices will be provided to all the participants (free of cost) and standard tooth brushing techniques will be demonstrated.
Written consent will be obtained from each participants, and then followed by case history taking along with clinical examination by recording various periodontal parameters taken in the study.
Following clinical periodontal parameters are to be recorded at baseline, at 1 week, at 2 weeks, and at 3 weeks:
- Modified Gingival Index
- Modified Plaque Index
Sample Size:
Minimum 90 patients with Generalized Chronic Gingivitis or Mild Generalized Chronic Periodontitis will be selected. Participants will be divided into 03 different groups, n=30 participants in each group by computer generated table of random numbers.
Data Collection And Methods:
Cases with Generalized Chronic Gingivitis or Mild Generalized Chronic Periodontitis of either sex and the age group 18-40 years who abide by approved protocol guidelines and are ready to give written informed consent will be selected randomly from OPD (outpatient department) of The Department of Periodontology, Govt. College of Dentistry, Indore (M.P.). The selected participants will be equally divided into three groups, by computer generated random number table.
- Conditions
- Periodontal Diseases, Gingivitis, Periodontitis
- Being tested
- Ocimum sanctum, Chlorhexidine Gluconate, Propylene Glycol
- Keywords
- Mouthrinse, Ocimum sanctum, Periodontal Diseases, Tulsi
- Medical subject headings
- Periodontal Diseases, Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocimum sanctumOther
Also called Tulsi, Holy Basil
Ocimum sanctum (known as Tulsi, Holy basil) is natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is one of the best examples of Ayurveda's holistic lifestyle approach to health. It is also been well practiced in traditional medicine in India and south Asian region. Literature showed that Ocimum sanctum extract have significant anti-gingivitis and anti-inflammatory effect as mouthrinse.
Chlorhexidine GluconateOther
Also called Chlorhexidine
Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. Chlorhexidine over a period of over 40 years has been thoroughly investigated and successfully used as plaque control agent in dental practice. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in variety of oral disorders in various formulations.
Propylene GlycolOther
Propylene glycol or 1,2-dihydroxypropane or 1,2-propanediol, is a clear, colourless, viscous, practically odourless liquid with a density of 1.038 g/cm³ at 20 °C and a molecular weight of 76.095. It is miscible with water, acetone and chloroform. It is miscible in water. Propylene glycol is commonly used as an excipient in a variety of drugs and it is also authorised in food products and cosmetics.
| Study group | Role | What they receive |
|---|---|---|
| Ocimum sanctum extract as mouthrinse | Experimental | 10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks. Receives: Other: Ocimum sanctum |
| Chlorhexidine Gluconate as mouthrinse | Active comparator | 10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks. Receives: Other: Chlorhexidine Gluconate |
| Propylene Glycol as mouthrinse | Placebo comparator | 10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks. Receives: Other: Propylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Gingival Index
The Modified Gingival Index (Lobene, Weatherford, Ross, Lamm, 1986) was recorded based on following criteria: 0 - Absence of inflammation. 1 - Mild inflammation or with slight changes in color and texture but, not in all portions of marginal or papillary gingiva. 2 - Mild inflammation, such as the preceding criteria, in all portions of marginal or papillary gingiva. 3 - Moderate, bright surface inflammation, erythema, edema, and/or hypertrophy of marginal or papillary gingiva. 4 - Severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. Modified Gingival Index = Total score of all teeth / no. of sites
Measured: Change from baseline Gingival index at 03 weeks
Secondary outcomes (1)
Modified Plaque Index
Plaque Index (Turesky, Gilmore, Glickman modification of Quigely Hein Index, 1970) Scoring was as follows: 0 - No plaque/debris. 1 - Separate flecks of plaque at the cervical margin of the tooth. 2 - A thin continuous band of plaque (up to 1mm) at the cervical margin of the tooth. 3 - A band of plaque wider than 1 mm but covering less than one third of the crown of the tooth. 4 - plaque covering at least one third but less than two thirds of the crown of the tooth. 5 - Plaque covering two third or more of the crown of the tooth. Plaque Index = Total score / no. of surfaces examined
Measured: Change from baseline Plaque index at 03 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start12 Apr 2017
- Primary completion22 Jul 2017
- Study completion31 Jul 2017
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 Periodontal DiseasesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government College of Dentistry, Indore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pratik kumar Ashok bhai Chaudhari, Government College of Dentistry, Indore
- Investigators
- Dr. Subhash Garg, M.D.S., Study director, Govt. College of Dentistry, Indore, Madhya pradesh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474146
- Sponsor's protocol ID
- 32/IEC/SS/2017
- Status last verified
- Apr 2018
- First submitted
- 8 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta D, Bhaskar DJ, Gupta RK, Karim B, Jain A, Singh R, Karim W. A randomized controlled clinical trial of Ocimum sanctum and chlorhexidine mouthwash on dental plaque and gingival inflammation. J Ayurveda Integr Med. 2014 Apr;5(2):109-16. doi: 10.4103/0975-9476.131727.
PubMed 24948862Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
PubMed 3485495Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 5264376
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Evaluation of Antiplaque and Antigingivitis Efficacy of Ocimum Sanctum (Tulsi) Extract Mouthrinse With 0.12% Chlorhexidine Mouthrinse - an in Vitro and in Vivo Study."
- ClinicalTrials.gov ID
- NCT03474146
- Acronym / sponsor ID
- 32/IEC/SS/2017
- Conditions
- Periodontal Diseases, Gingivitis, Periodontitis
- Keywords
- Mouthrinse, Ocimum sanctum, Periodontal Diseases, Tulsi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Government College of Dentistry, IndoreUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 22 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 22 Mar 2018 (actual)
- 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.
Chlorhexidine is considered as gold standard for its antiplaque and antigingivitis efficacy till date but it has got many side effects. So it is need of the hour that investigators will find some substitute having similar antiplque and antigingivitis efficay but have less or no adverse effects. so in this study investigators planned to do "Comparative evaluation of antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with 0.12% chlorhexidine mouthrinse.
Detailed description
Title:
"Comparative evaluation of antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with 0.12% chlorhexidine mouthrinse - an in vitro and in vivo study."
Aims And Objectives:
- To evaluate the antimicrobial activity of Ocimum sanctum (Tulsi) extract by Sensitivity testing, Minimum Inhibitory Concentration, Minimum Bactericidal Concentration, and Time kill curve -In Vitro study.
- To evaluate the Antiplaque and Antigingivitis effect of the Ocimum sanctum (Tulsi) by recording Modified Gingival Index and Modified Plaque Index in patients with Chronic Generalized Gingivitis and Mild Chronic Generalized Periodontitis -In Vivo study.
- Clinical evaluation and comparison of the Antiplaque and Antigingivitis effect of the Ocimum sanctum (Tulsi) with 0.12% Chlorhexidine and vehicle.
- To see the topical beneficial and/or harmful side effects of Ocimum sanctum extract, if any.
Study Design:
Prospective randomized controlled Trial- Randomized Comparative Study
Methodology (Material \& Methods):
The present study will have following parts:
- Procurement of extract and formulation of mouthrinse: Ocimum sanctum (Tulsi) extract has been purchased from the ISO (International Organization for Standardization) Certified shop. The desired mouthrinse will be formulated under the guidance of Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.)
- In vitro study: Sensitivity testing, Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC), of Ocimum sanctum will be determined against following microorganisms: Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tannerella forsythia, Pseudomonas aeruginosa, and other microorganisms.
- In vivo study: This study has been planned and would be conducted in the Department of Periodontology, Govt. College of Dentistry, Indore, Madhya pradesh, India. In this study, participants with Chronic Generalized Gingivitis and Mild Chronic Generalized Periodontitis would be randomly selected from outdoor patients. A minimum 90 Recruited participants will be divided into three equal groups randomly. (Parallel design, case control, Randomized Comparative Study).
Group A: (Test group) (n=30) Ocimum sanctum extract as mouthrinse. Group B: (Positive control group) (n=30) 0.12% Chlorhexidine as mouthrinse. Group C: (control group) (n=30) Vehicle as the mouthrinse. All the three solutions would be prepared under the valuable guidance of Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.) and will be kept in coded containers. All the participants in each group would be advised to use their respective mouth rinses twice daily with proper swishing action for a minute, after brushing their teeth (in the morning and before going to bed). To maintain standardization, similar toothbrushes and dentifrices will be provided to all the participants (free of cost) and standard tooth brushing techniques will be demonstrated.
Written consent will be obtained from each participants, and then followed by case history taking along with clinical examination by recording various periodontal parameters taken in the study.
Following clinical periodontal parameters are to be recorded at baseline, at 1 week, at 2 weeks, and at 3 weeks:
- Modified Gingival Index
- Modified Plaque Index
Sample Size:
Minimum 90 patients with Generalized Chronic Gingivitis or Mild Generalized Chronic Periodontitis will be selected. Participants will be divided into 03 different groups, n=30 participants in each group by computer generated table of random numbers.
Data Collection And Methods:
Cases with Generalized Chronic Gingivitis or Mild Generalized Chronic Periodontitis of either sex and the age group 18-40 years who abide by approved protocol guidelines and are ready to give written informed consent will be selected randomly from OPD (outpatient department) of The Department of Periodontology, Govt. College of Dentistry, Indore (M.P.). The selected participants will be equally divided into three groups, by computer generated random number table.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ocimum sanctum extract as mouthrinse | Experimental | Other: Ocimum sanctum10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks. |
| Chlorhexidine Gluconate as mouthrinse | Active comparator | Other: Chlorhexidine Gluconate10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks. |
| Propylene Glycol as mouthrinse | Placebo comparator | Other: Propylene Glycol10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cases with generalized chronic gingivitis or cases with mild generalized chronic periodontitis patients of any sex.
- Systemically healthy individuals.
- Participants having >20 teeth.
- Participants in the age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent.
Key exclusion criteria (7 listed)
- Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.
- Participants on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and drugs since 03 months.
- Participants who have known allergy to material used for the study.
- Pregnant and lactating mothers.
- Participants had undergone any kind of nonsurgical and/or surgical periodontal therapy earlier, 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 |
|---|---|---|
| Ocimum sanctumAlso: Tulsi, Holy BasilOcimum sanctum (known as Tulsi, Holy basil) is natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is one of the best examples of Ayurveda's holistic lifestyle approach to health. It is also been well practiced in traditional medicine in India and south Asian region. Literature showed that Ocimum sanctum extract have significant anti-gingivitis and anti-inflammatory effect as mouthrinse. | Other | Ocimum sanctum extract as mouthrinse |
| Chlorhexidine GluconateAlso: ChlorhexidineChlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. Chlorhexidine over a period of over 40 years has been thoroughly investigated and successfully used as plaque control agent in dental practice. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in variety of oral disorders in various formulations. | Other | Chlorhexidine Gluconate as mouthrinse |
| Propylene GlycolPropylene glycol or 1,2-dihydroxypropane or 1,2-propanediol, is a clear, colourless, viscous, practically odourless liquid with a density of 1.038 g/cm³ at 20 °C and a molecular weight of 76.095. It is miscible with water, acetone and chloroform. It is miscible in water. Propylene glycol is commonly used as an excipient in a variety of drugs and it is also authorised in food products and cosmetics. | Other | Propylene Glycol as mouthrinse |
Primary outcome
Modified Gingival Index
Time frame: Change from baseline Gingival index at 03 weeks
The Modified Gingival Index (Lobene, Weatherford, Ross, Lamm, 1986) was recorded based on following criteria: 0 - Absence of inflammation. 1 - Mild inflammation or with slight changes in color and texture but, not in all portions of marginal or papillary gingiva. 2 - Mild inflammation, such as the preceding criteria, in all portions of marginal or papillary gingiva. 3 - Moderate, bright surface inflammation, erythema, edema, and/or hypertrophy of marginal or papillary gingiva. 4 - Severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. Modified Gingival Index = Total score of all teeth / no. of sites
1 secondary outcome
Modified Plaque Index
Time frame: Change from baseline Plaque index at 03 weeks
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 17 Apr 2018.
- Background: PubMed 24948862Gupta D, Bhaskar DJ, Gupta RK, Karim B, Jain A, Singh R, Karim W. A randomized controlled clinical trial of Ocimum sanctum and chlorhexidine mouthwash on dental plaque and gingival inflammation. J Ayurveda Integr Med. 2014 Apr;5(2):109-16. doi: 10.4103/0975-9476.131727.
- Background: PubMed 3485495Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
- Background: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Individual participant dataSharing planned: No
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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.
Dr. Subhash Garg, M.D.S. study director
Govt. College of Dentistry, Indore, Madhya pradesh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocimum sanctum, Chlorhexidine Gluconate and Propylene Glycol in people with Periodontal Diseases and Gingivitis, 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 4 inclusion and 7 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 17 Apr 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. Some participants in this study may receive a placebo. 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?
Modified Gingival Index (time frame: Change from baseline Gingival index at 03 weeks). 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 NCT03474146, 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 17 Apr 2018.