Tooth WearNCT07081204
Evaluation of Temporomandibular Disorders and Their Association With Tooth Wear Using Digital Methods
An observational study of Tooth Wear and Occlusal Wear of Teeth, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular disorders (TMDs) are considered complex conditions in dental practice due to their multifactorial etiology. Over the years, various diagnostic methods have been introduced; however, the most widely accepted model to explain the complexity of TMD is the biopsychosocial model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear, Occlusal Wear of Teeth, Occlusal Analysis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2024to 30 May 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes individuals aged 18 years and older who have an adequate number of premolar and molar teeth in the posterior region, without systemic diseases, and without active dental pain or recent trauma to the face or neck. All participants were voluntarily selected from among patients who applied to the Department of Prosthodontics at the Faculty of Dentistry, Necmettin Erbakan University.
Who may be able to join
- Adults aged 18 years and above
- Voluntary participation with signed informed consent
- Presence of a sufficient number of posterior teeth (premolars and molars)
- Willingness to undergo intraoral digital scanning
- Willingness to participate in occlusal contact analysis procedures
Who cannot join
- Presence of systemic diseases affecting the temporomandibular joint (TMJ)
- Active dental pain at the time of evaluation
- Recent trauma to the facial or jaw region
- Current psychiatric or neurological disorders
- History of orthodontic treatment or extensive prosthetic rehabilitation
- Pathological jaw dysfunctions not related to parafunctional activity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Konya, 42090
About this study
Official title: Evaluation of the Prevalence of Temporomandibular Disorders and Lts Association With Tooth Wear Measured Using Digital Methods
Temporomandibular disorders (TMDs) are considered complex conditions in dental practice due to their multifactorial etiology. Over the years, various diagnostic methods have been introduced; however, the most widely accepted model to explain the complexity of TMD is the biopsychosocial model. The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and Axis II protocol is currently regarded as the gold standard for evaluating TMDs. Today, studies employing the DC/TMD framework are conducted in various populations.
This study aims to assess the prevalence of TMD using updated diagnostic criteria. In addition, it seeks to evaluate the presence of tooth wear-one of the common clinical findings associated with TMD-through digital measurement and visual assessment tools, and to investigate its correlation with TMD. Specifically, the study will examine how changes in occlusal contact points due to bruxism and wear are reflected in functional changes within the temporomandibular joint (TMJ) and the extent of tooth wear. The effects of both mild and severe tooth wear on TMJ health and their potential long-term implications for oral health will also be explored.
Read more
The primary objective of this study is to determine the prevalence of TMD in the general population using the DC/TMD Axis I and Axis II protocols and to evaluate the impact of tooth wear-measured via digital intraoral scanners-on TMD. Special attention will be given to how changes in occlusal contact due to bruxism and wear influence stress distribution and adaptive remodeling in TMJ structures. Furthermore, the study aims to compare the effects of mild versus severe tooth wear on joint function, ultimately contributing to the development of early diagnosis and intervention strategies.
Additionally, this study seeks to highlight the effectiveness of digital technologies, such as intraoral scanners and 3D modeling, in evaluating the relationship between tooth wear and TMJ disorders. By doing so, the research aims to enhance the existing literature on the link between tooth wear and TMD and provide evidence-based guidance for clinical practice.
Read the detailed description
This analytical cross-sectional clinical study was conducted at the Department of Prosthodontics, Faculty of Dentistry, Necmettin Erbakan University between November 2024 and May 2025. The study aimed to investigate the relationship between tooth wear, occlusal contact area, and temporomandibular disorders (TMD) using validated diagnostic and digital tools. Ethical approval was granted by the Non-Invasive Clinical Research Ethics Committee of Necmettin Erbakan University (Approval No: 2024/520; Date: 26.12.2024; ID: 22023.R1). Written informed consent was obtained from all participants in accordance with the Declaration of Helsinki.
Sample size was determined using G*Power software (v3.1), with an effect size of f = 0.33, alpha = 0.05, and power = 0.90, indicating that a minimum of 40 participants per group was required. A total of 120 subjects were included.
TMD diagnosis was based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), following the 2014 Axis I protocol. Participants were classified into three groups:
None: No signs of TMD M: Muscular pain (myogenic) T: Joint-related pain (arthrogenic) The diagnostic process was based on clinical findings such as pain elicited by jaw movement, muscle palpation, or joint loading. Muscle-related pain was further subclassified according to whether the pain extended beyond anatomical boundaries (local muscle pain, myofascial pain, or referred pain). TMJ-originated pain was defined as pain induced by joint palpation or mandibular movements. TMJ-related headache diagnosis was based on pain elicited in the temporal area via palpation or functional movement.
Pain intensity and interference were assessed using the Graded Chronic Pain Scale Version 2.0 (GCPS v2.0). The Characteristic Pain Intensity (CPI) was calculated as the mean of items 2-4 multiplied by 10. The Interference Score was the mean of items 6-8, also multiplied by 10. Disability points were assigned based on the number of painful days in the past 30 days (item 5), resulting in a total pain grade from 0 (no pain) to 3 (severe pain).
Digital occlusal analysis was performed using the Medit i700 intraoral scanner (Medit Corp., Seoul, South Korea). All scans were taken once in the morning under maximum intercuspation. STL files were analyzed with the Medit Occlusal Analyzer plugin. Occlusal contact area percentages for premolars and molars were calculated, and non-contacting teeth were excluded. The average occlusal contact area per individual was used for statistical evaluation.
Tooth wear classification was performed using the Tooth Wear Evaluation System 2.0 (TWES 2.0) as proposed by Wetselaar et al. Occlusal/incisal and non-occlusal/non-incisal surfaces were graded on a 5-point ordinal scale.
For occlusal/incisal surfaces:
Grade 0: No visible wear Grade 1: Wear within enamel Grade 2: Dentin exposure with ≤1/3 crown height loss Grade 3: Crown height loss >1/3 but <2/3 Grade 4: Crown height loss ≥2/3
For non-occlusal surfaces (oral/vestibular):
Grade 0: No visible wear Grade 1: Wear within enamel Grade 2: Dentin exposure <50% of surface Grade 3: Dentin exposure ≥50% of surface Grade 4: Dentin exposure with total enamel/pulp loss Tooth wear grades were recorded separately for each tooth and surface. For statistical analysis, wear severity was simplified into three categories: no wear, enamel-level wear, and dentin-level wear.
Standardization and blinding were maintained by ensuring all scans and measurements were conducted by the same experienced prosthodontist using the same equipment in a controlled setting. TMD classification, wear evaluation, and pain assessment were carried out independently by different examiners.
Statistical analysis was performed using IBM SPSS Statistics 23. Shapiro-Wilk test assessed the normality of continuous variables. Non-parametric tests were used for non-normally distributed variables. Kruskal-Wallis test and Dwass-Steel-Critchlow-Fligner (DSCF) post hoc test with Bonferroni correction were used for group comparisons. Spearman's rho correlation was used to examine associations between variables. Multinomial logistic regression was applied to identify factors affecting TMD group classification. Ordinal logistic regression assessed the effects of pain level, wear severity, and occlusal contact. The interaction between pain and wear severity on TMD classification was analyzed using Generalized Linear Models (GLM). Statistical significance was set at p < 0.05.
Study limitations include its single-center design, limiting generalizability. Functional occlusal contacts during dynamic movements were not evaluated, and only static intercuspal position was analyzed. Additionally, due to insufficient data in pain Grade 4, this subgroup was excluded from analysis.
- Conditions
- Tooth Wear, Occlusal Wear of Teeth, Occlusal Analysis, TMJ, Temporomandibular Disorders (TMD)
- Keywords
- Digital Dentistry, Temporomandibular Disorders, Tooth Wear
- Medical subject headings
- Tooth Wear, Temporomandibular Joint Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal contact area percentage in posterior teeth (%)
Occlusal contact area will be calculated as a percentage of the total occlusal surface area in posterior teeth. Digital impressions will be acquired using the Medit i700 intraoral scanner. Contact points will be identified with the Medit Occlusal Analyzer plugin, and contact areas will be measured from STL files using ImageJ software (version 1.54). The percentage will be computed by dividing the total occlusal contact area by the total occlusal surface area.
Measured: Baseline (Day 1 of clinical evaluation)
Secondary outcomes (2)
Tooth wear severity score assessed by TWES 2.0 (ordinal scale: 0-4)
Tooth wear severity will be assessed visually according to the Tooth Wear Evaluation System 2.0 (TWES 2.0). Both occlusal/incisal and non-occlusal/non-incisal surfaces will be scored on a 0 to 4 ordinal scale. A composite severity score will be recorded for each participant.
Measured: Baseline (Day 1 of clinical evaluation)
Pain severity score using Graded Chronic Pain Scale v2.0 (unit: 0-4 categorical score)
Pain severity will be assessed using the Graded Chronic Pain Scale version 2.0 (GCPS v2.0). The total score is derived by combining the Characteristic Pain Intensity (CPI), the disability score (based on the number of days with pain), and the functional interference score. The final score categorizes individuals into one of five levels (0 to 4), where higher scores indicate more severe and functionally limiting pain.
Measured: Baseline (Day 1 of clinical evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start26 Dec 2024
- Primary completion20 Feb 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WearStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Gözen, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081204
- Sponsor's protocol ID
- 22023.R1
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Temporomandibular Disorders and Lts Association With Tooth Wear Measured Using Digital Methods
- ClinicalTrials.gov ID
- NCT07081204
- Acronym / sponsor ID
- 22023.R1
- Conditions
- Tooth Wear, Occlusal Wear of Teeth, Occlusal Analysis, TMJ, Temporomandibular Disorders (TMD)
- Keywords
- Digital Dentistry, Temporomandibular Disorders, Tooth Wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 23 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.
Temporomandibular disorders (TMDs) are considered complex conditions in dental practice due to their multifactorial etiology. Over the years, various diagnostic methods have been introduced; however, the most widely accepted model to explain the complexity of TMD is the biopsychosocial model. The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and Axis II protocol is currently regarded as the gold standard for evaluating TMDs. Today, studies employing the DC/TMD framework are conducted in various populations.
This study aims to assess the prevalence of TMD using updated diagnostic criteria. In addition, it seeks to evaluate the presence of tooth wear-one of the common clinical findings associated with TMD-through digital measurement and visual assessment tools, and to investigate its correlation with TMD. Specifically, the study will examine how changes in occlusal contact points due to bruxism and wear are reflected in functional changes within the temporomandibular joint (TMJ) and the extent of tooth wear. The effects of both mild and severe tooth wear on TMJ health and their potential long-term implications for oral health will also be explored.
The primary objective of this study is to determine the prevalence of TMD in the general population using the DC/TMD Axis I and Axis II protocols and to evaluate the impact of tooth wear-measured via digital intraoral scanners-on TMD. Special attention will be given to how changes in occlusal contact due to bruxism and wear influence stress distribution and adaptive remodeling in TMJ structures. Furthermore, the study aims to compare the effects of mild versus severe tooth wear on joint function, ultimately contributing to the development of early diagnosis and intervention strategies.
Additionally, this study seeks to highlight the effectiveness of digital technologies, such as intraoral scanners and 3D modeling, in evaluating the relationship between tooth wear and TMJ disorders. By doing so, the research aims to enhance the existing literature on the link between tooth wear and TMD and provide evidence-based guidance for clinical practice.
Detailed description
This analytical cross-sectional clinical study was conducted at the Department of Prosthodontics, Faculty of Dentistry, Necmettin Erbakan University between November 2024 and May 2025. The study aimed to investigate the relationship between tooth wear, occlusal contact area, and temporomandibular disorders (TMD) using validated diagnostic and digital tools. Ethical approval was granted by the Non-Invasive Clinical Research Ethics Committee of Necmettin Erbakan University (Approval No: 2024/520; Date: 26.12.2024; ID: 22023.R1). Written informed consent was obtained from all participants in accordance with the Declaration of Helsinki.
Sample size was determined using G*Power software (v3.1), with an effect size of f = 0.33, alpha = 0.05, and power = 0.90, indicating that a minimum of 40 participants per group was required. A total of 120 subjects were included.
TMD diagnosis was based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), following the 2014 Axis I protocol. Participants were classified into three groups:
None: No signs of TMD M: Muscular pain (myogenic) T: Joint-related pain (arthrogenic) The diagnostic process was based on clinical findings such as pain elicited by jaw movement, muscle palpation, or joint loading. Muscle-related pain was further subclassified according to whether the pain extended beyond anatomical boundaries (local muscle pain, myofascial pain, or referred pain). TMJ-originated pain was defined as pain induced by joint palpation or mandibular movements. TMJ-related headache diagnosis was based on pain elicited in the temporal area via palpation or functional movement.
Pain intensity and interference were assessed using the Graded Chronic Pain Scale Version 2.0 (GCPS v2.0). The Characteristic Pain Intensity (CPI) was calculated as the mean of items 2-4 multiplied by 10. The Interference Score was the mean of items 6-8, also multiplied by 10. Disability points were assigned based on the number of painful days in the past 30 days (item 5), resulting in a total pain grade from 0 (no pain) to 3 (severe pain).
Digital occlusal analysis was performed using the Medit i700 intraoral scanner (Medit Corp., Seoul, South Korea). All scans were taken once in the morning under maximum intercuspation. STL files were analyzed with the Medit Occlusal Analyzer plugin. Occlusal contact area percentages for premolars and molars were calculated, and non-contacting teeth were excluded. The average occlusal contact area per individual was used for statistical evaluation.
Tooth wear classification was performed using the Tooth Wear Evaluation System 2.0 (TWES 2.0) as proposed by Wetselaar et al. Occlusal/incisal and non-occlusal/non-incisal surfaces were graded on a 5-point ordinal scale.
For occlusal/incisal surfaces:
Grade 0: No visible wear Grade 1: Wear within enamel Grade 2: Dentin exposure with ≤1/3 crown height loss Grade 3: Crown height loss >1/3 but <2/3 Grade 4: Crown height loss ≥2/3
For non-occlusal surfaces (oral/vestibular):
Grade 0: No visible wear Grade 1: Wear within enamel Grade 2: Dentin exposure <50% of surface Grade 3: Dentin exposure ≥50% of surface Grade 4: Dentin exposure with total enamel/pulp loss Tooth wear grades were recorded separately for each tooth and surface. For statistical analysis, wear severity was simplified into three categories: no wear, enamel-level wear, and dentin-level wear.
Standardization and blinding were maintained by ensuring all scans and measurements were conducted by the same experienced prosthodontist using the same equipment in a controlled setting. TMD classification, wear evaluation, and pain assessment were carried out independently by different examiners.
Statistical analysis was performed using IBM SPSS Statistics 23. Shapiro-Wilk test assessed the normality of continuous variables. Non-parametric tests were used for non-normally distributed variables. Kruskal-Wallis test and Dwass-Steel-Critchlow-Fligner (DSCF) post hoc test with Bonferroni correction were used for group comparisons. Spearman's rho correlation was used to examine associations between variables. Multinomial logistic regression was applied to identify factors affecting TMD group classification. Ordinal logistic regression assessed the effects of pain level, wear severity, and occlusal contact. The interaction between pain and wear severity on TMD classification was analyzed using Generalized Linear Models (GLM). Statistical significance was set at p < 0.05.
Study limitations include its single-center design, limiting generalizability. Functional occlusal contacts during dynamic movements were not evaluated, and only static intercuspal position was analyzed. Additionally, due to insufficient data in pain Grade 4, this subgroup was excluded from analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes individuals aged 18 years and older who have an adequate number of premolar and molar teeth in the posterior region, without systemic diseases, and without active dental pain or recent trauma to the face or neck. All participants were voluntarily selected from among patients who applied to the Department of Prosthodontics at the Faculty of Dentistry, Necmettin Erbakan University.
Key inclusion criteria (5 listed)
- Adults aged 18 years and above
- Voluntary participation with signed informed consent
- Presence of a sufficient number of posterior teeth (premolars and molars)
- Willingness to undergo intraoral digital scanning
- Willingness to participate in occlusal contact analysis procedures
Key exclusion criteria (6 listed)
- Presence of systemic diseases affecting the temporomandibular joint (TMJ)
- Active dental pain at the time of evaluation
- Recent trauma to the facial or jaw region
- Current psychiatric or neurological disorders
- History of orthodontic treatment or extensive prosthetic rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occlusal contact area percentage in posterior teeth (%)
Time frame: Baseline (Day 1 of clinical evaluation)
Occlusal contact area will be calculated as a percentage of the total occlusal surface area in posterior teeth. Digital impressions will be acquired using the Medit i700 intraoral scanner. Contact points will be identified with the Medit Occlusal Analyzer plugin, and contact areas will be measured from STL files using ImageJ software (version 1.54). The percentage will be computed by dividing the total occlusal contact area by the total occlusal surface area.
2 secondary outcomes
Tooth wear severity score assessed by TWES 2.0 (ordinal scale: 0-4)
Time frame: Baseline (Day 1 of clinical evaluation)
Pain severity score using Graded Chronic Pain Scale v2.0 (unit: 0-4 categorical score)
Time frame: Baseline (Day 1 of clinical evaluation)
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 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Wear and Occlusal Wear of Teeth, run by Konya Necmettin Erbakan Üniversitesi at 1 site 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 5 inclusion and 6 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 23 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 1 site 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?
Occlusal contact area percentage in posterior teeth (%) (time frame: Baseline (Day 1 of clinical evaluation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.