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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03782311
Other study ID # c37taicm
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date November 2016

Study information

Verified date December 2018
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date November 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

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.).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
motivation and and oral hygiene instructions
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Outcome

Type Measure Description Time frame Safety issue
Primary oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed Woelber et al. in 2015 baseline
Primary "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 1 mouth
Primary "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 3 mouth
Primary plaque index (min:0, max:5, lower values represent a better), averaged Quigley & Hein (1962) Plaque Index baseline
Primary "change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged Quigley & Hein (1962) Plaque Index 1 month
Primary "change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged Quigley & Hein (1962) Plaque Index 3 month
Secondary General Self Efficacy (GSE) score (min:10, max: 40), summed Schwarzer & Jerusalem, 1995 baseline
Secondary Demographic variables age, gender, smoking, number of teeth, education, income baseline
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