NCT03782311

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

December 15, 2018

Last Update Submit

December 18, 2018

Conditions

Outcome Measures

Primary Outcomes (6)

  • oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed

    Woelber et al. in 2015

    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

    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

    3 mouth

  • plaque index (min:0, max:5, lower values represent a better), averaged

    Quigley \& Hein (1962) Plaque Index

    baseline

  • "change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged

    Quigley \& Hein (1962) Plaque Index

    1 month

  • "change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged

    Quigley \& Hein (1962) Plaque Index

    3 month

Secondary Outcomes (2)

  • General Self Efficacy (GSE) score (min:10, max: 40), summed

    baseline

  • Demographic variables

    baseline

Study Arms (1)

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 .

Behavioral: motivation and and oral hygiene instructions

Interventions

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.

2 groups: OHSE-high and OHSE-low

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Gingivitis and periodontitis patients

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Gul Atilla

    clinical professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 20, 2018

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

November 1, 2016

Last Updated

December 20, 2018

Record last verified: 2018-12