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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06316505
Other study ID # 11/2023-58
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date March 1, 2024

Study information

Verified date March 2024
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Oral hygiene motivation with individual oral photograps
Oral photograps was taken at control sessions.

Locations

Country Name City State
Turkey Atatürk University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Didem OZKAL EMINOGLU

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical periodontal parameters / plaque index (PI) 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
Primary Clinical periodontal parameters / gingival index (GI) 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
Primary Clinical periodontal parameters / probing pocket depth (PPD). 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
Primary Clinical periodontal parameters / bleeding on probing (BOP) 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
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