NCT07065019

Brief Summary

Internalized stigma refers to the adoption of negative judgments, beliefs, stereotypes and stigmatizing views imposed by society. The aim of this study was to investigate internalized stigma in patients with tooth loss due to periodontitis. This study included a total of 155 volunteer individuals diagnosed with Stage III or Stage IV periodontitis. 'Internalized Stigma Scale in Mental Illness', 'Individual Information Collection Form' including sociodemographic data and 'Patient Evaluation Form' including clinical periodontal parameters were obtained from these volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

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

May 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 12, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

periodontal diseaseinternalized stigmatooth loss

Outcome Measures

Primary Outcomes (2)

  • Internalized stigma in patients with tooth loss due to periodontitis

    Tooth loss due to periodontitis refers to the extraction or spontaneous exfoliation of a tooth as a direct consequence of the progressive destruction of the tooth-supporting structures, including the periodontal ligament, alveolar bone, and connective tissue attachment. This destruction results from chronic inflammation and tissue breakdown caused by periodontal pathogens. Teeth are considered lost due to periodontitis when mobility, severe attachment loss, and bone resorption render them non-functional, painful, or unsalvageable despite periodontal therapy. Internalized Stigma of Mental Illness Scale assessment was performed in patients with tooth loss due to periodontitis.Internalized Stigma of Mental Illness Scale is a Likert-type scale calculated as 'strongly disagree' (1 point), 'disagree' (2 points), 'agree' (3 points), 'strongly agree' (4 points).High scores on this scale indicate how aggressive the person's internalized stigma is negatively.

    6 months

  • The correlation between potential internalized stigma and different sociodemographic factors.

    Sociodemographic data such as age, gender, marital status, education level, income level, smoking status, presence of systemic diseases, reason for referral, and frequency of tooth brushing were recorded.Internalized Stigma of Mental Illness Scale is a Likert-type scale calculated as 'strongly disagree' (1 point), 'disagree' (2 points), 'agree' (3 points), 'strongly agree' (4 points).High scores on this scale indicate how aggressive the person's internalized stigma is negatively.

    6 months

Secondary Outcomes (4)

  • The correlation between potential internalized stigma and plaque index

    6 months

  • The correlation between potential internalized stigma and gingival index (GI)

    6 months

  • The correlation between potential internalized stigma and probing pocket depth

    6 months

  • The correlation between potential internalized stigma and clinical attachment loss

    6 months

Study Arms (2)

Stage III periodontitis

The diagnosis of Stage III generalized periodontitis was established based on the presence of one or more of the following clinical and radiographic findings: a probing pocket depth (PD) of ≥ 6 mm and/or clinical attachment loss (CAL) of ≥ 5 mm; radiographic evidence of bone loss extending to the middle or apical third of the root; a history of tooth loss due to periodontitis involving four or fewer teeth; CAL of ≥ 5 mm affecting 30% or more of the dentition; vertical bone loss of ≥ 3 mm; Class II or III furcation involvement; and the presence of moderate ridge defects.

Other: The Internalized Stigma Scale in Mental Illness (ISS)

Stage IV periodontitis

The diagnosis of Stage IV generalized periodontitis was based on more severe manifestations, including CAL of ≥ 5 mm and radiographic bone loss reaching the middle or apical third of the root. Additionally, patients exhibited tooth loss due to periodontitis affecting five or more teeth, masticatory dysfunction, occlusal dysfunction, severe ridge defects, and/or signs of secondary occlusal trauma.

Other: The Internalized Stigma Scale in Mental Illness (ISS)

Interventions

The ISS consists of 29 items and is a self-report scale assessing internalized stigma. ISS includes 5 subscales: 1. Alienation (6 items), 2. Confirmation of Stereotypes (7 items), 3. Perceived Discrimination (5 items), 4. Social Withdrawal (6 items), 5. Resistance to Stigmatization (5 items). ISS is a Likert-type scale calculated as 'strongly disagree' (1 point), 'disagree' (2 points), 'agree' (3 points), 'strongly agree' (4 points). The items of the 'Resistance to stigmatization' subscale are reverse scored. High scores on this scale indicate how aggressive the person's internalized stigma is negatively. ISS has been adapted for many diseases other than mental illnesses in our country and its validity and reliability have been demonstrated.

Stage III periodontitisStage IV periodontitis

Eligibility Criteria

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

This study included patients diagnosed with Generalized Stage III and Generalized Stage IV periodontitis, according to the criteria defined in the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions

You may qualify if:

  • Tooth loss due to interproximal CAL and mobility caused by periodontal disease
  • Patients must be over 18 and under 65 years of age
  • Demonstrate adequate cognitive function and comprehension skills, as assessed through clinical observation.
  • Know how to read and write
  • Patients do not have any neurological disease that may affect the perception of internalized stigma
  • Patients volunteering to participate in the study

You may not qualify if:

  • Has any medical condition or neurological disease that may affect the perception of internalized stigma
  • Patients with tooth loss due to reasons other than interproximal CAC and mobility caused by periodontal disease
  • The appearance of teeth lost due to periodontitis concealed by a fixed or removable prosthesis
  • Those who do not want to participate in the survey
  • Lack sufficient cognitive and comprehension abilities as determined through clinical observation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nezahat Arzu Kayar

Antalya, Antalya, 07070, Turkey (Türkiye)

Location

Nezahat Arzu Kayar

Konyaalti, Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (2)

  • Sum MY, Wong CTW, Chu ST, Li A, Lee AHT, Chen EYH, Chan SKW. Systematic review and meta-analysis of internalised stigma and stigma resistance in patients with psychosis: The impact of individualism-collectivism culture and other individual factors. Int J Soc Psychiatry. 2024 Jun;70(4):639-652. doi: 10.1177/00207640231216924. Epub 2024 Jan 26.

    PMID: 38279534BACKGROUND
  • Zain Ul Abideen M, Ali Bushara NA, Nadeem Baig M, Dilshad Siddiqui Y, Ejaz I, Tareen J, Siddiqui AA. Shining a Spotlight on Stigma: Exploring Its Impact on Oral Health-Seeking Behaviours Through the Lenses of Patients and Caregivers. Cureus. 2024 Jun 24;16(6):e63025. doi: 10.7759/cureus.63025. eCollection 2024 Jun.

    PMID: 39050292BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesTooth Loss

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Nezahat Arzu Kayar, Phd

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 12, 2025

First Posted

July 15, 2025

Study Start

May 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations