Gingiva; InfectionNCT04830176
Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis
A study testing dentifrice in people with Gingiva; Infection and Plaque, Dental, run by Ajman University at 1 site in India.
Trial summary
The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingiva; Infection, Plaque, Dental
- What is being tested?
- dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jan 2021to 28 Mar 2021
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects having only plaque induced gingival inflammation
Who cannot join
- Subjects having gingival inflammation related to underling systemic diseases
- Subjects taking medications
- Gingival inflammation related to other causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Moringa Dentifirice in the Management of Plaque Induced Gingivitis. A Clinical Crossover Study
The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken.
Read the detailed description
The clinical cross over study involves use of miswak and moringa dentifrices. The patients selected are 30 in no and are selected based on having gingival inflammation due to plaque accumulation. All other cases related to gingival inflammation along with patients with underlying systemic disease are excluded from the study.
At baseline, plaque and gingival scores are recorded, followed by giving one of the dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked to report after 72 hrs, following which another recording of plaque and gingival scores are recorded.
The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash out period and recalled after this 2 week interval.
The patients are then given the second dentifrice and asked to brush for 72 hrs and then asked to report again for a plaque and gingival score evaluation.
- Conditions
- Gingiva; Infection, Plaque, Dental
- Being tested
- dentifrice
- Keywords
- miswak, moringa, plaque, gingival bleeding
- Medical subject headings
- Infections, Dental Plaque, Plaque, Amyloid, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dentifriceOther
use of dentifrices for brushing
| Study group | Role | What they receive |
|---|---|---|
| moringa | Active comparator | First phase of subjects were given dentifrice for brushing Receives: Other: dentifrice |
| miswak | Active comparator | second phase of subjects were given dentifrice for brushing Receives: Other: dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque scores
plaque score recorded using calibrated periodontal probes
Measured: 72 hours
Secondary outcomes (1)
Gingival inflammation scores
Gingival bleeding scores recorded using caliberated periodontal probes
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start20 Jan 2021
- Primary completion20 Mar 2021
- Study completion28 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingiva; InfectionStudies 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
- Crossover
- Model description
- sample size of 30- First group of 15 subjects recording of plaque and gingival scores were recorded. Patients were given first dentifrice and asked to brush for 72 hours and then asked to report. A washout period of 2 weeks followed. The next round, the subjects were given the second dentifrice and asked to brush for 72 hrs and then after a period of 3days asked to report
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Collaborators
- A B Shetty Memorial Institute of Dental Science
- Responsible party
- Principal investigator, sudhir rama varma, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830176
- Sponsor's protocol ID
- D-F-19-03-04
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this study will be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Moringa Dentifirice in the Management of Plaque Induced Gingivitis. A Clinical Crossover Study
- ClinicalTrials.gov ID
- NCT04830176
- Acronym / sponsor ID
- D-F-19-03-04
- Conditions
- Gingiva; Infection, Plaque, Dental
- Keywords
- miswak, moringa, plaque, gingival bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Collaborators
- A B Shetty Memorial Institute of Dental Science
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 28 Mar 2021 (actual)
- First posted
- 5 Apr 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.
The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken.
Detailed description
The clinical cross over study involves use of miswak and moringa dentifrices. The patients selected are 30 in no and are selected based on having gingival inflammation due to plaque accumulation. All other cases related to gingival inflammation along with patients with underlying systemic disease are excluded from the study.
At baseline, plaque and gingival scores are recorded, followed by giving one of the dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked to report after 72 hrs, following which another recording of plaque and gingival scores are recorded.
The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash out period and recalled after this 2 week interval.
The patients are then given the second dentifrice and asked to brush for 72 hrs and then asked to report again for a plaque and gingival score evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- sample size of 30- First group of 15 subjects recording of plaque and gingival scores were recorded. Patients were given first dentifrice and asked to brush for 72 hours and then asked to report. A washout period of 2 weeks followed. The next round, the subjects were given the second dentifrice and asked to brush for 72 hrs and then after a period of 3days asked to report
| Arm | Type | Receives |
|---|---|---|
| moringa | Active comparator | Other: dentifriceFirst phase of subjects were given dentifrice for brushing |
| miswak | Active comparator | Other: dentifricesecond phase of subjects were given dentifrice for brushing |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- subjects having only plaque induced gingival inflammation
Key exclusion criteria (3 listed)
- Subjects having gingival inflammation related to underling systemic diseases
- Subjects taking medications
- Gingival inflammation related to other causes
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 |
|---|---|---|
| dentifriceuse of dentifrices for brushing | Other | miswak, moringa |
Primary outcome
plaque scores
Time frame: 72 hours
plaque score recorded using calibrated periodontal probes
1 secondary outcome
Gingival inflammation scores
Time frame: 72 hours
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 8 Apr 2021.
- Individual participant dataSharing planned: Yes. The results of this study will be shared to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dentifrice in people with Gingiva; Infection and Plaque, Dental, run by Ajman 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 1 inclusion and 3 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 8 Apr 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.
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 scores (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021.