- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06316505
Oral Photographs of Patients on Oral Hygiene Motivation
Use of Oral Photographs of Patients on Oral Hygiene Motivation Promotes Periodontal Health: a Prospective Randomized Controlled Trial
Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters.
Participants will get conventional oral hygiene education (COHE) with/without visual motivation using self oral photographs of patients.
Researchers will compare Intervention group and control groups on oral hygiene by comparing changes in clinical periodontal parameters.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Maintaining oral health requires a motivated patient. The adherence to a lifelong oral hygiene regimen is significantly influenced by an individual's motivation and manual dexterity. The physician's responsibility in this context is to provide guidance to the patient regarding the appropriate and efficient oral hygiene routine, as well as to motivate their adherence to it. The definition of motivation is to stimulate action or effort towards a particular goal or objective. Motivation is a condition that can be altered in response to external influences and time, rather than being a characteristic. The primary objective of motivation is to enhance persons' knowledge of this matter by highlighting oral health, introducing oral hygiene, and offering information on efficacious mechanical cleaning procedures for eliminating factors that contribute to the deterioration of oral hygiene.
Participants were divided into 2 groups using https://www.randomizer.org/ website:
Control group (CG) (n=28): Conventional oral hygiene education (COHE) [22]
Intervention group (IG) (n=28): In addition to COHE, the following steps were followed:
- Session 1: A photograph was taken before (F1) and after (F2) full-mouth scaling root planing (fmSRP). Then the patient was shown the difference.
- 2nd session: A photograph was taken (F3) and the patient is shown the difference between F1 and F3.
- 3rd session: A photograph was taken (F4) and the patient is shown the difference between F1 - F3 - F4.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey, 25240_
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age ranging from 18-60 years;
- a minimum of 12 teeth;
- and being available for the follow-up assessment
- participants were wanted to be right-handers when toothbrushing to standardization.
Exclusion Criteria:
- Patients with systemic illnesses or conditions,
- smokers and individuals taking any medication that may affect periodontal health were not included in the study.
- Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group (CG)
Conventional oral hygiene education (COHE)
|
|
|
Experimental: Intervention group (IG)
In addition to COHE, oral hygiene motivation with individual oral photographs
|
Oral photograps was taken at control sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical periodontal parameters / plaque index (PI)
Time Frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system.
Higher scores mean a worse outcome.
|
T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
|
Clinical periodontal parameters / gingival index (GI)
Time Frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
The presence and extent of gingival inflammation and bleeding were graded according to the gingival index system.
Higher scores mean a worse outcome.
|
T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
|
Clinical periodontal parameters / probing pocket depth (PPD).
Time Frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
PPD was measured as the distance between the deepest point of the sulcus and the gingival margin.
Higher scores mean a worse outcome.
|
T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
|
Clinical periodontal parameters / bleeding on probing (BOP)
Time Frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
The presence of bleeding on probing is considered an objective sign of periodontal inflammation.
Higher scores mean a worse outcome.
|
T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Didem Özkal Eminoğlu, Ataturk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11/2023-58
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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