Periodontal DiseasesRPPDNCT03316755
Risk Perception of Periodontal Disease
A study testing Exposure in people with Periodontal Diseases, run by University of Benin at 1 site in Nigeria.
Trial summary
This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Mar 2017to 7 Oct 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- consenting dental patients
Who cannot join
- non consenting dental patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Perception of Periodontal Disease: A Randomised Clinical Trial
This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic
Read the detailed description
This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic. The outcome will help activate a success oriented periodontal disease prevention model
- Conditions
- Periodontal Diseases
- Being tested
- Exposure
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureBehavioural
Exposure to pamphlet
| Study group | Role | What they receive |
|---|---|---|
| without pamphlet | No intervention | a group not exposed to pamphlet |
| With pamphlets | Experimental | a group exposed to pamphlet Receives: Behavioral: Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk perception
Questionnaire
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Mar 2017
- Primary completion4 Oct 2017
- Study completion7 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- randomised
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Benin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clement Chinedu Azodo, University of Benin
- Investigators
- Clement C Azodo, Principal investigator, UBTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316755
- Sponsor's protocol ID
- Perio
- Acronym
- RPPD
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Perception of Periodontal Disease: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03316755
- Acronym / sponsor ID
- RPPD / Perio
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of BeninUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 7 Oct 2017 (actual)
- First posted
- 20 Oct 2017 (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.
This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic
Detailed description
This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic. The outcome will help activate a success oriented periodontal disease prevention model
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised
| Arm | Type | Receives |
|---|---|---|
| without pamphlet | No intervention | –a group not exposed to pamphlet |
| With pamphlets | Experimental | Behavioral: Exposurea group exposed to pamphlet |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- consenting dental patients
Key exclusion criteria (1 listed)
- non consenting dental patients
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 |
|---|---|---|
| ExposureExposure to pamphlet | Behavioural | With pamphlets |
Primary outcome
Risk perception
Time frame: 1month
Questionnaire
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 20 Oct 2017.
- 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.
Clement C Azodo principal investigator
UBTH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure in people with Periodontal Diseases, run by University of Benin at 1 site in Nigeria.
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 1 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 20 Oct 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 Nigeria. 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?
Risk perception (time frame: 1month). 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 20 Oct 2017.