NCT07530978

Brief Summary

This cross-sectional study aims to evaluate the relationship between oral hygiene habits, periodontal status, and oral health-related quality of life in adult individuals. A total of approximately 160 participants attending the Department of Periodontology will be included. Periodontal status will be assessed using standard clinical parameters, including probing depth, clinical attachment loss, bleeding on probing, and plaque index. In addition, the Periodontal Inflamed Surface Area (PISA) will be calculated to quantify inflammatory burden. Oral health-related quality of life will be evaluated using the OSHIP-Perio questionnaire, a validated patient-reported outcome measure specific to periodontal conditions. The study will investigate the association between clinical periodontal findings, oral hygiene practices, and quality of life outcomes. The findings are expected to provide a comprehensive understanding of both clinical and patient-centered aspects of periodontal disease and contribute to improved individualized treatment approaches.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 9, 2026

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oral health-related quality of life (OSHIP-Perio score)

    The primary outcome is the Oral and Systemic Health Impact Profile for Periodontal Disease (OSHIP-Perio) total score obtained from a 21-item questionnaire assessing the impact of periodontal status on oral health-related quality of life.

    Baseline (single visit)

Secondary Outcomes (5)

  • Probing Pocket Depth (PPD)

    Baseline (single visit)

  • Periodontitis Stage (2017 Classification)

    Baseline (single visit)

  • Clinical Attachment Level (CAL)

    Baseline (single visit)

  • Bleeding on Probing (BOP)

    Baseline (single visit)

  • Periodontitis Grade (2017 Classification)

    Baseline (single visit)

Study Arms (3)

PERIODONTITIS PATIENTS

Patients with a diagnosis of periodontitis, irrespective of its stage and grade.This group will include individuals diagnosed with periodontitis, characterized by interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth and/or buccal/oral CAL ≥3 mm with pocketing \>3 mm at ≥2 teeth, not attributable to non-periodontal causes. Participants will present with increased probing pocket depths (PPD ≥4 mm), bleeding on probing (BOP), and radiographic evidence of alveolar bone loss. The diagnosis and staging of periodontitis will be established according to the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

Other: Oral Health Assessment and OSHIP-Perio Questionnaire

GINGIVITIS PATIENTS

This group will include individuals diagnosed with gingivitis, characterized by the presence of gingival inflammation without clinical attachment loss or radiographic evidence of alveolar bone loss. Participants will exhibit bleeding on probing (BOP) ≥10%, with probing pocket depths (PPD) ≤3 mm at all sites. The diagnosis of gingivitis will be established according to the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

Other: Oral Health Assessment and OSHIP-Perio Questionnaire

periodontally healthy individuals

This group will consist of systemically healthy individuals presenting with clinically healthy periodontal tissues. Participants will have no clinical signs of gingival inflammation, no periodontal pocket formation, no clinical attachment loss (CAL), and no radiographic evidence of alveolar bone loss. All individuals in this group will demonstrate probing pocket depths (PPD) ≤3 mm at all sites and bleeding on probing (BOP) \<10%, in accordance with the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

Other: Oral Health Assessment and OSHIP-Perio Questionnaire

Interventions

Participants will undergo a comprehensive periodontal clinical examination, including assessment of probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque and gingival indices. In addition, participants will complete the OSHIP-Perio questionnaire to evaluate the impact of periodontal status on oral health-related quality of life. No invasive or therapeutic intervention will be performed as part of this study.

GINGIVITIS PATIENTSPERIODONTITIS PATIENTSperiodontally healthy individuals

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of individuals aged 18 years and older presenting to the Department of Periodontology at Bolu Abant İzzet Baysal University Faculty of Dentistry. Participants will be classified into periodontally healthy, gingivitis, and periodontitis groups according to the 2017 classification of periodontal diseases and conditions.

You may qualify if:

  • Individuals aged 18 years and older
  • Patients presenting to the Department of Periodontology Individuals willing to participate and provide informed consent

You may not qualify if:

  • Use of antibiotics or anti-inflammatory drugs within the last 3 months
  • History of periodontal treatment within the last 6 months
  • Pregnancy or lactation
  • Individuals unable to complete the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics

Bolu, Bolu, 14100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontal DiseasesGingivitisPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Central Study Contacts

Zeynep Akgül Akgul, DDS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSIST PROF

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Study Start

October 15, 2025

Primary Completion

May 15, 2026

Study Completion

June 15, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared to protect participant confidentiality. De-identified and aggregated data may be available from the corresponding author upon reasonable request.

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