Chronic GingivitisPhase 2/3NCT04767269
Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.
A Phase 2/3 study testing Cuminum Cyminum and herbal Mouthwash in people with Chronic Gingivitis, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine. Read more about this study
- Who is it for?
- Ages 23 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Gingivitis
- What is being tested?
- Cuminum Cyminum and herbal Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 31 Jan 2021
- Phase
- Phase 2/3
- 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 23 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteers with minimum 20 natural teeth without restoration.
- cooperative
- motivated and committed to participate in the trial period.
Who cannot join
- Antibiotic or anti-inflammatory therapy in previous month.
- Any known allergy/ hypersensitivity to any product used in trial.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontology, M.M. College of Dental Sciences and Research.
Ambāla, Haryana, 133207
About this study
Official title: Efficacy of Cuminum Cyminum Herbal Preparation in Inhibition of Plaque and Gingivitis
Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.
Read the detailed description
To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.
- Conditions
- Chronic Gingivitis
- Being tested
- Cuminum Cyminum, herbal Mouthwash
- Keywords
- Mouthwash, chlorhexidine, stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuminum CyminumDrug
Also called Cuminum Cyminum mouthwash
Cuminum Cyminum mouthwash in chronic gingivitis patients
herbal MouthwashDrug
Also called herbal mouthwash in chronic gingivitis patients
herbal mouthwash in chronic gingivitis patients
| Study group | Role | What they receive |
|---|---|---|
| cuminum cyminum mouthwash | Experimental | cuminum cyminum mouthwash in chronic gingivitis patients Receives: Drug: Cuminum Cyminum |
| herbal mouthwash | Active comparator | herbal mouthwash in chronic gingivitis patients Receives: Drug: herbal Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLAQUE INDEX
PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962
Measured: changes from baseline to 8 days
Gingival Index
Gingival Index: Loe H ans Silness 1963
Measured: changes from baseline to 8 days
Bleeding on probing
Bleeding on probing: Muhlemann HR and Son 1971
Measured: changes from baseline to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jan 2019
- Primary completion15 Jan 2021
- Study completion31 Jan 2021
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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1. Group phase A 2. Group phase B 3. Group phase C
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- surinder sachdeva, M.D.S., Principal investigator, PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767269
- Sponsor's protocol ID
- MaharishiMu2012
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Southern EN, McCombs GB, Tolle SL, Marinak K. The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis. J Dent Hyg. 2006 Winter;80(1):12. Epub 2006 Jan 1.
PubMed 16451766Salgado AD, Maia JL, Pereira SL, de Lemos TL, Mota OM. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract: a double-blind clinical study in humans. J Appl Oral Sci. 2006 Jun;14(3):162-6. doi: 10.1590/s1678-77572006000300003.
PubMed 19089066Bettaieb I, Bourgou S, Wannes WA, Hamrouni I, Limam F, Marzouk B. Essential oils, phenolics, and antioxidant activities of different parts of cumin (Cuminum cyminum L.). J Agric Food Chem. 2010 Oct 13;58(19):10410-8. doi: 10.1021/jf102248j.
PubMed 20809647
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cuminum Cyminum Herbal Preparation in Inhibition of Plaque and Gingivitis
- ClinicalTrials.gov ID
- NCT04767269
- Acronym / sponsor ID
- MaharishiMu2012
- Conditions
- Chronic Gingivitis
- Keywords
- Mouthwash, chlorhexidine, stain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 23 Feb 2021 (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.
Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.
Detailed description
To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Group phase A 2. Group phase B 3. Group phase C
| Arm | Type | Receives |
|---|---|---|
| cuminum cyminum mouthwash | Experimental | Drug: Cuminum Cyminumcuminum cyminum mouthwash in chronic gingivitis patients |
| herbal mouthwash | Active comparator | Drug: herbal Mouthwashherbal mouthwash in chronic gingivitis patients |
Who may qualify
- Ages
- 23 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- volunteers with minimum 20 natural teeth without restoration.
- cooperative
- motivated and committed to participate in the trial period.
Key exclusion criteria (2 listed)
- Antibiotic or anti-inflammatory therapy in previous month.
- Any known allergy/ hypersensitivity to any product used in trial.
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 |
|---|---|---|
| Cuminum CyminumAlso: Cuminum Cyminum mouthwashCuminum Cyminum mouthwash in chronic gingivitis patients | Drug | cuminum cyminum mouthwash |
| herbal MouthwashAlso: herbal mouthwash in chronic gingivitis patientsherbal mouthwash in chronic gingivitis patients | Drug | herbal mouthwash |
Primary outcome
PLAQUE INDEX
Time frame: changes from baseline to 8 days
PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962
Gingival Index
Time frame: changes from baseline to 8 days
Gingival Index: Loe H ans Silness 1963
Bleeding on probing
Time frame: changes from baseline to 8 days
Bleeding on probing: Muhlemann HR and Son 1971
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 24 Feb 2021.
- Background: PubMed 16451766Southern EN, McCombs GB, Tolle SL, Marinak K. The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis. J Dent Hyg. 2006 Winter;80(1):12. Epub 2006 Jan 1.
- Background: PubMed 19089066Salgado AD, Maia JL, Pereira SL, de Lemos TL, Mota OM. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract: a double-blind clinical study in humans. J Appl Oral Sci. 2006 Jun;14(3):162-6. doi: 10.1590/s1678-77572006000300003.
- Background: PubMed 20809647Bettaieb I, Bourgou S, Wannes WA, Hamrouni I, Limam F, Marzouk B. Essential oils, phenolics, and antioxidant activities of different parts of cumin (Cuminum cyminum L.). J Agric Food Chem. 2010 Oct 13;58(19):10410-8. doi: 10.1021/jf102248j.
- 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.
surinder sachdeva, M.D.S. principal investigator
PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cuminum Cyminum and herbal Mouthwash in people with Chronic Gingivitis, run by Maharishi Markendeswar University (Deemed to be University) 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 2 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 24 Feb 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: changes from baseline to 8 days). The study lists 3 primary outcomes in all. 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 NCT04767269, 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 24 Feb 2021.