NCT06316505

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 12, 2024

Last Update Submit

March 20, 2024

Conditions

Periodontal DiseasesMotivationHygiene

Keywords

oral hygieneperiodontal healthperiodontal indicesmotivationModified Bass Technique

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Control group (CG)

NO INTERVENTION

Conventional oral hygiene education (COHE)

Intervention group (IG)

EXPERIMENTAL

In addition to COHE, oral hygiene motivation with individual oral photographs

Behavioral: Oral hygiene motivation with individual oral photograps

Interventions

Oral hygiene motivation with individual oral photograpsBEHAVIORAL

Oral photograps was taken at control sessions.

Intervention group (IG)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, 25240_, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozkal Eminoglu D, Sahin BN, Bicer D, Dal G, Huseynli I, Dadashov A, Betul Dogan D, Kasali K. Using patients' oral photographs for oral hygiene motivation promotes periodontal health: a prospective randomized controlled trial. BMC Oral Health. 2024 Jul 13;24(1):786. doi: 10.1186/s12903-024-04553-7.

    PMID: 38997684DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • DİDEM ÖZKAL EMİNOĞLU

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 18, 2024

Study Start

December 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)