NCT05809570

Brief Summary

The purpose of this study was to develop a periodontal disease prediction software and a patient-based gingival recession simulator for clinical practice aiming at improving oral hygiene motivation of patients with periodontal problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,057

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

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

June 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

March 30, 2023

Last Update Submit

April 12, 2023

Conditions

Periodontal Diseases

Keywords

gingival recessionOral hygiene motivationComputer-aided design

Outcome Measures

Primary Outcomes (1)

  • Number of sites Clinical Attachment Loss≥5 mm

    Categorized as: None, \<4, 4-8, \>8

    Baseline

Secondary Outcomes (17)

  • Presence of diabetes

    Baseline

  • Smoking status

    Baseline

  • Patient cooperation and awareness

    Baseline

  • History of dental treatment

    Baseline

  • Tooth brushing Habits

    Baseline

  • +12 more secondary outcomes

Study Arms (1)

Periodontal examination

Cross- sectional clinical periodontal examinations and measurements were performed using a Williams periodontal probe

Diagnostic Test: Clinical examination

Interventions

Clinical examinationDIAGNOSTIC_TEST

A total of 1057 individuals who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology and agreed to participate in the study were clinically and radiologically examined. An intraoral scanner was utilized to capture direct optical intraoral data of a patient.

Periodontal examination

Eligibility Criteria

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

Patients who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology for their rutin periodontal controls or complains about gingival problems were included in this study.

You may qualify if:

  • Age greater than 18 years,
  • Periodontal status ranging from no clinical periodontal disease (\<10% with bleeding on probing) to periodontitis (stage I to IV)
  • Patients having at least one teeth in each quadrant were included.

You may not qualify if:

  • Patients undergoing orthodontic treatment and using anti-inflammatory drugs were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesGingival Recession

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGingival DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Şadiye Günpınar, Assoc. Prof

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

June 1, 2020

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

TU(1)