NCT07545109

Brief Summary

This study aims to evaluate periodontal health status and its impact on oral health-related quality of life by combining clinical periodontal parameters with validated patient-reported outcome measures. Periodontal assessments included probing pocket depth (PPD), clinical attachment loss (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BOP). Participants were further classified according to periodontal disease staging and grading. To assess the subjective impact of periodontal conditions on daily life, the Oral Health Impact Profile-14 (OHIP-14) and its shortened version, the Oral Health Impact Profile-14 short form (OShip-14), were administered.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

Periodontal diseaseOHİP-14OSHİP-14Clinical attachment loss

Outcome Measures

Primary Outcomes (1)

  • OSHİP-14

    OShip-14 is a 14-item short-form questionnaire designed to assess oral health-related quality of life, evaluating the physical, psychological, and social impacts of oral and dental health on daily life.

    One-time assessment at enrollment

Study Arms (4)

Stage I Periodontitis (Mild)

Participants with mild periodontitis characterized by initial periodontal breakdown, probing pocket depth (PPD) ≤4 mm, and minimal clinical attachment loss (CAL).

Other: No Interventions

Stage II Periodontitis (Moderate)

Participants with moderate periodontitis characterized by PPD ≤5 mm and moderate CAL without significant functional impairment or tooth loss.

Other: No Interventions

Group 3: Stage III Periodontitis (Severe)

Participants with severe periodontitis characterized by PPD ≥6 mm, advanced CAL, furcation involvement, and increased risk of tooth loss

Other: No Interventions

Group 4: Stage IV Periodontitis (Advanced)

Participants with advanced periodontitis characterized by extensive attachment loss, severe bone destruction, and impaired masticatory function or tooth loss.

Other: No Interventions

Interventions

Participants underwent a comprehensive periodontal examination, including probing pocket depth (PPD), clinical attachment loss (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BOP) assessments. In addition, oral health-related quality of life was evaluated using the OHIP-14 and OShip-14 questionnaires. No therapeutic or pharmacological intervention was applied.

Also known as: Periodontal assessment and questionnaire evaluation
Group 3: Stage III Periodontitis (Severe)Group 4: Stage IV Periodontitis (Advanced)Stage I Periodontitis (Mild)Stage II Periodontitis (Moderate)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Systemically healthy individuals aged 18-65 years diagnosed with periodontitis and willing to participate in the study.

You may qualify if:

  • Aged between 18 and 65 years Diagnosed with periodontitis (any stage) Willing to participate in the study and provide informed consent

You may not qualify if:

  • Refusal to participate in the study Pregnancy or lactation Use of antibiotics or anti-inflammatory drugs within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 22, 2026

Study Start

September 1, 2025

Primary Completion

March 1, 2026

Study Completion

May 5, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect patient privacy and confidentiality.

Locations