Periodontal DiseasesNCT07065019
Internalized Stigma and Tooth Loss Due to Periodontitis
An observational study of Periodontal Diseases and Tooth Loss, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Tooth Loss
- What is being tested?
- The Internalized Stigma Scale in Mental Illness (ISS)
- Type of treatment
- Injection or infusion
- How many people
- 155 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Nezahat Arzu Kayar
Antalya, Antalya, 07070
Nezahat Arzu Kayar
Konyaalti, Antalya, 07070
About this study
Official title: Internalized Stigma in Patients With Tooth Loss Due to Periodontitis: A Cross-Sectional Study
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.
Read the detailed description
This study included 155 volunteer individuals diagnosed with Stage III and Stage IV periodontitis who applied to Akdeniz University Faculty of Dentistry Periodontology Clinic between May 2023 and July 2024. '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. This study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013. After the rationale and method of the study were explained to the volunteers included in the study, a minimum informed consent form was signed.
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.
Data Collection Procedure and Indexes:
The internalized stigma scale(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.In a recent study . ISS has been shown to be valid and reliable in halitosis (Cronbach's alpha = 0.89). In the current study, the Internalized Stigma of Mental Illness (ISMI) Scale demonstrated high internal consistency, with a Cronbach's alpha coefficient of 0.947.
- Conditions
- Periodontal Diseases, Tooth Loss
- Being tested
- The Internalized Stigma Scale in Mental Illness (ISS)
- Keywords
- periodontal disease, internalized stigma, tooth loss
- Medical subject headings
- Periodontal Diseases, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Internalized Stigma Scale in Mental Illness (ISS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: The Internalized Stigma Scale in Mental Illness (ISS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
The correlation between potential internalized stigma and plaque index
These measurements were taken at specific sites around each tooth via a Williams periodontal probe.
The Plaque Index (PI), as described by Silness and Löe, is used to assess the thickness of plaque at the gingival area.Without using disclosing agents, the presence of plaque is assessed visually and by gently passing the probe along the gingival margin. Each surface is scored on a scale from 0 to 3:
Score 0: No plaque.
Score 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth, detectable only by running a probe across the tooth surface.
Score 2: Moderate accumulation of soft deposits within the gingival pocket or on the tooth and gingival margin, visible to the naked eye.
Score 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: 6 months
The correlation between potential internalized stigma and gingival index (GI)
The GI was measured at six sites per tooth, according to Löe \& Silness: 0- Normal gingiva; 1- Mild inflammation with slight color change, mild alteration of gingival surface structure and no bleeding on probing; 2- Moderate inflammation with edema, redness, swelling and bleeding on probing; 3- Severe inflammation with marked edema and redness, ulceration and tendency to bleed spontaneously.These measurements were taken at specific sites around each tooth via a graduated periodontal probe.
Measured: 6 months
The correlation between potential internalized stigma and probing pocket depth
Probing pocket depth were taken at six sites/tooth and recorded using a Williams periodontal probe. PPD is measured as the distance from the gingival margin to the base of the gingival sulcus or periodontal pocket. A calibrated periodontal probe is gently inserted parallel to the long axis of the tooth into the sulcus or pocket until slight resistance is felt at the base. The depth is recorded in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. This measurement reflects the current inflammatory status and pocket formation around the tooth.
Measured: 6 months
The correlation between potential internalized stigma and clinical attachment loss
The CAL is measured by determining the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket or sulcus. A calibrated periodontal probe is gently inserted into the gingival sulcus or pocket, and the probing depth (PD) is recorded. If the gingival margin is located coronal to the CEJ, the distance from the gingival margin to the CEJ is subtracted from the probing depth. If the gingival margin is apical to the CEJ (in cases of recession), this distance is added to the probing depth. The resulting value represents the CAL, which reflects the extent of periodontal support loss.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 May 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezahat Arzu Kayar, Akdeniz University
- Investigators
- Nezahat Arzu Kayar, Phd, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065019
- Sponsor's protocol ID
- KAEK-304
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38279534Zain 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.
PubMed 39050292
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internalized Stigma in Patients With Tooth Loss Due to Periodontitis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07065019
- Acronym / sponsor ID
- KAEK-304
- Conditions
- Periodontal Diseases, Tooth Loss
- Keywords
- periodontal disease, internalized stigma, tooth loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study included 155 volunteer individuals diagnosed with Stage III and Stage IV periodontitis who applied to Akdeniz University Faculty of Dentistry Periodontology Clinic between May 2023 and July 2024. '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. This study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013. After the rationale and method of the study were explained to the volunteers included in the study, a minimum informed consent form was signed.
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.
Data Collection Procedure and Indexes:
The internalized stigma scale(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.In a recent study . ISS has been shown to be valid and reliable in halitosis (Cronbach's alpha = 0.89). In the current study, the Internalized Stigma of Mental Illness (ISMI) Scale demonstrated high internal consistency, with a Cronbach's alpha coefficient of 0.947.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage III periodontitis | – | Other: The Internalized Stigma Scale in Mental Illness (ISS)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. |
| Stage IV periodontitis | – | Other: The Internalized Stigma Scale in Mental Illness (ISS)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Internalized Stigma Scale in Mental Illness (ISS)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. | Other | Stage III periodontitis, Stage IV periodontitis |
Primary outcome
Internalized stigma in patients with tooth loss due to periodontitis
Time frame: 6 months
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.
The correlation between potential internalized stigma and different sociodemographic factors.
Time frame: 6 months
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.
4 secondary outcomes
The correlation between potential internalized stigma and plaque index
Time frame: 6 months
The correlation between potential internalized stigma and gingival index (GI)
Time frame: 6 months
The correlation between potential internalized stigma and probing pocket depth
Time frame: 6 months
The correlation between potential internalized stigma and clinical attachment loss
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Results publication: PubMed 38279534Sum 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.
- Results publication: PubMed 39050292Zain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nezahat Arzu Kayar, Phd principal investigator
Akdeniz University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Tooth Loss, run by Akdeniz University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalized stigma in patients with tooth loss due to periodontitis (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065019, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.