Dental PlaqueNCT03782311
Oral Hygiene Related Self-efficacy, General Self-efficacy and Daily Plaque Control
An observational study of Dental Plaque, run by Ege University.
Trial summary
The objectives are a) to determine the scores of general self-efficacy (GSE) and oral hygiene related self-efficacy (OHSE) b) to evaluate the relations between the scores of GSE and OHSE c) to examine the changes in OHSE scores and the relationship between OHSE and PI scores after motivation and oral hygiene… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Dental Plaque
- What is being tested?
- motivation and and oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Nov 2016
- Phase
- Observational
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Gingivitis and periodontitis patients
Who may be able to join
- Inclusion criteria were being able to brushing and interdental cleaning physically and mentally, between the ages of 35 and 60, graduated from high school or university, having at least 12 teeth, no periodontal treatment in the last 6 months, no periodontal surgery in the last 2 years.
Who cannot join
- Patients with one or more of the following criteria were excluded from the study: patients having hepatitis or HIV infectious disease, pregnant and lactating females, patients taking drugs that may cause gingival bleeding and gingival enlargement, and bleeding problems (thrombocytopenia, hemophilia A-B, iron deficiency anemia etc.).
About this study
Official title: The Relationship Between Oral Hygiene Related Self-efficacy, General Self-efficacy and Daily Plaque Control
The objectives are a) to determine the scores of general self-efficacy (GSE) and oral hygiene related self-efficacy (OHSE) b) to evaluate the relations between the scores of GSE and OHSE c) to examine the changes in OHSE scores and the relationship between OHSE and PI scores after motivation and oral hygiene instructions. OHSE scores could be an indicator in predicting daily plaque control of patients. Also, it may be needed to show greater interest about motivation and oral hygiene instructions especially for smokers and OHSE-low group patients.
Read the detailed description
All study patients (n=210) between the ages of 35 to 60 with inflammatory periodontal diseases filled out questionnaires regarding GSE and OHSE. Subgroups including OHSE-low (n=26) and OHSE-high (n=26) groups were selected after performing "cut off" on OHSE scores of all study patients. In both subgroups, plaque index (PI) values were determined, and motivation and oral hygiene instructions were performed at baseline. PI measurements and OHSE questionnaire were repeated at 1 and 3 months.
- Conditions
- Dental Plaque
- Being tested
- motivation and and oral hygiene instructions
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivation and and oral hygiene instructionsBehavioural
Motivation and oral hygiene instructions were received OHSE-high and OHSE-low groups. After showing the modified-Bass tooth brushing technique and interdental cleaning on the model, patients were followed up while brushing and flossing their teeth to correct misapplications. It was advised to brush teeth twice a day and use the interdental cleaning devices once a day.
| Study group | Role | What they receive |
|---|---|---|
| 2 groups: OHSE-high and OHSE-low | OHSE-high: Group with ≥ 50 OHSE scores received motivation and oral hygiene instructions .
OHSE-low: Group with < 30 OHSE scores received motivation and oral hygiene instructions . Receives: Behavioral: motivation and and oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed
Woelber et al. in 2015
Measured: baseline
"change" is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better), summed
Woelber et al. in 2015
Measured: 1 mouth
"change" is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed
Woelber et al. in 2015
Measured: 3 mouth
plaque index (min:0, max:5, lower values represent a better), averaged
Quigley \& Hein (1962) Plaque Index
Measured: baseline
"change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged
Quigley \& Hein (1962) Plaque Index
Measured: 1 month
"change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged
Quigley \& Hein (1962) Plaque Index
Measured: 3 month
Secondary outcomes (2)
General Self Efficacy (GSE) score (min:10, max: 40), summed
Schwarzer \& Jerusalem, 1995
Measured: baseline
Demographic variables
age, gender, smoking, number of teeth, education, income
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study startMay 2015
- Primary completionFeb 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Atilla, Ege University
- Investigators
- Gul Atilla, Principal investigator, clinical professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782311
- Sponsor's protocol ID
- c37taicm
- Status last verified
- Dec 2018
- First submitted
- 15 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Oral Hygiene Related Self-efficacy, General Self-efficacy and Daily Plaque Control
- ClinicalTrials.gov ID
- NCT03782311
- Acronym / sponsor ID
- c37taicm
- Conditions
- Dental Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Dec 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.
The objectives are a) to determine the scores of general self-efficacy (GSE) and oral hygiene related self-efficacy (OHSE) b) to evaluate the relations between the scores of GSE and OHSE c) to examine the changes in OHSE scores and the relationship between OHSE and PI scores after motivation and oral hygiene instructions. OHSE scores could be an indicator in predicting daily plaque control of patients. Also, it may be needed to show greater interest about motivation and oral hygiene instructions especially for smokers and OHSE-low group patients.
Detailed description
All study patients (n=210) between the ages of 35 to 60 with inflammatory periodontal diseases filled out questionnaires regarding GSE and OHSE. Subgroups including OHSE-low (n=26) and OHSE-high (n=26) groups were selected after performing "cut off" on OHSE scores of all study patients. In both subgroups, plaque index (PI) values were determined, and motivation and oral hygiene instructions were performed at baseline. PI measurements and OHSE questionnaire were repeated at 1 and 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 groups: OHSE-high and OHSE-low | – | Behavioral: motivation and and oral hygiene instructionsOHSE-high: Group with ≥ 50 OHSE scores received motivation and oral hygiene instructions . OHSE-low: Group with < 30 OHSE scores received motivation and oral hygiene instructions . |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Gingivitis and periodontitis patients
Key inclusion criteria (1 listed)
- Inclusion criteria were being able to brushing and interdental cleaning physically and mentally, between the ages of 35 and 60, graduated from high school or university, having at least 12 teeth, no periodontal treatment in the last 6 months, no periodontal surgery in the last 2 years.
Key exclusion criteria (1 listed)
- Patients with one or more of the following criteria were excluded from the study: patients having hepatitis or HIV infectious disease, pregnant and lactating females, patients taking drugs that may cause gingival bleeding and gingival enlargement, and bleeding problems (thrombocytopenia, hemophilia A-B, iron deficiency anemia etc.).
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 |
|---|---|---|
| motivation and and oral hygiene instructionsMotivation and oral hygiene instructions were received OHSE-high and OHSE-low groups. After showing the modified-Bass tooth brushing technique and interdental cleaning on the model, patients were followed up while brushing and flossing their teeth to correct misapplications. It was advised to brush teeth twice a day and use the interdental cleaning devices once a day. | Behavioural | 2 groups: OHSE-high and OHSE-low |
Primary outcome
oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed
Time frame: baseline
Woelber et al. in 2015
"change" is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better), summed
Time frame: 1 mouth
Woelber et al. in 2015
"change" is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed
Time frame: 3 mouth
Woelber et al. in 2015
plaque index (min:0, max:5, lower values represent a better), averaged
Time frame: baseline
Quigley \& Hein (1962) Plaque Index
"change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged
Time frame: 1 month
Quigley \& Hein (1962) Plaque Index
"change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged
Time frame: 3 month
Quigley \& Hein (1962) Plaque Index
2 secondary outcomes
General Self Efficacy (GSE) score (min:10, max: 40), summed
Time frame: baseline
Demographic variables
Time frame: baseline
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 Dec 2018.
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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.
Gul Atilla principal investigator
clinical professor
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Plaque, run by Ege University.
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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed (time frame: baseline). The study lists 6 primary outcomes in all. 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 Dec 2018.