BruxismNCT07088887
Bruxism Awareness Prior to Dental Implant Treatment
An observational study of Bruxism, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Bruxism is a parafunctional habit characterized by clenching or grinding of the teeth and/or mandibular thrusting, which may occur during sleep or wakefulness. It is associated with various dental complications, including implant failures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 15 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of 150 systemically healthy adult patients aged 18 to 65 who applied to the Department of Periodontology at Gülhane Faculty of Dentistry, University of Health Sciences, Ankara, Turkey, between March and June 2025. All participants were seeking dental implant therapy. The sample represents a clinical population attending a tertiary care academic dental center, with diverse educational and socioeconomic backgrounds. Patients with intellectual disabilities, psychiatric disorders, or conditions impairing questionnaire comprehension were excluded. This observational cohort was selected to evaluate the presence of bruxism and patient awareness prior to implant placement.
Who may be able to join
- Participants included in the study were individuals aged between 18 and 65 years,
- who were systemically healthy and
- able to comprehend and respond to the questionnaire items
Who cannot join
- Individuals with intellectual disabilities,
- suicidal tendencies, dementia,
- or psychosis were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gulhane Faculty of Dentistry,
Ankara
About this study
Official title: Bruxism Awareness as a Pre-Treatment Consideration in Dental Implantology
Bruxism is a parafunctional habit characterized by clenching or grinding of the teeth and/or mandibular thrusting, which may occur during sleep or wakefulness. It is associated with various dental complications, including implant failures. Despite its prevalence, awareness of bruxism among patients remains limited, and diagnostic methods vary. This study aims to evaluate the presence and type of bruxism in patients undergoing dental implant treatment and to assess their awareness levels. The findings may help prevent implant-related complications by supporting early identification and appropriate management of bruxism.
Research Questions What is the prevalence of awake and sleep bruxism in patients scheduled for dental implant treatment?
Read more
To what extent are patients aware of their bruxism habits prior to treatment?
What are the most common signs and symptoms of bruxism observed in this patient group?
Is there a correlation between patients' self-reported bruxism and clinical findings?
Can increased bruxism awareness before implant procedures help reduce the risk of future implant and prosthetic complications?
Read the detailed description
This observational study involves systemically healthy adult patients scheduled for dental implant treatment at a university dental faculty. Clinical examinations were performed to detect characteristic signs of bruxism, and validated self-report tools-including the Bruxism Questionnaire, Fonseca Anamnestic Index, and Perceived Stress Scale-were used to assess both subjective awareness and emotional stress. Additionally, a customized awareness questionnaire was administered to evaluate patients' perceptions and knowledge of bruxism.
- Conditions
- Bruxism
- Being tested
- control group
- Keywords
- bruxism, dental implant, Fonseca Anamnestic Index, Perceived Stress Scale-14, awareness.
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
The control group included patients aged 18-65 who were systemically healthy, had no clinical or self-reported signs of bruxism, and were eligible for implant treatment. Data collected included demographic characteristics (age, gender), systemic and periodontal health status, and clinical examination findings confirming the absence of bruxism. These patients also completed the Fonseca Anamnestic Index (FAI) to assess temporomandibular disorder (TMD) symptoms and the Perceived Stress Scale-14 (PSS-14) to evaluate emotional stress levels. A bruxism awareness questionnaire was also applied to determine baseline knowledge in individuals without bruxism. All assessments were conducted before implant surgery using standardized diagnostic tools.
| Study group | Role | What they receive |
|---|---|---|
| Bruxism group | The study group included patients aged 18-65 who were systemically healthy and suitable for implant treatment. Collected data covered demographic variables (age, gender), systemic and periodontal health status, and detailed clinical findings. Bruxism was assessed both clinically-based on signs such as masseter hypertrophy and dental wear-and through self-reported questionnaires to determine its type (awake or sleep). Patients also completed the Fonseca Anamnestic Index (FAI) to evaluate temporomandibular disorder (TMD) severity and the Perceived Stress Scale-14 (PSS-14) to assess emotional stress levels. Additionally, a bruxism awareness questionnaire was administered. All evaluations were performed prior to implant surgery using standardized diagnostic forms and validated scales. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of bruxism
Bruxism assessment in this study was based on both clinical examination and self-reported measures. Clinical diagnosis followed the 2018 international consensus criteria, requiring at least two of the following signs: masseter muscle pain or hypertrophy (extraoral), dental wear, linea alba on the buccal mucosa, or recurrent restoration failures (intraoral). Self-reported bruxism was evaluated using a standardized questionnaire based on Lobbezoo et al.'s grading system, distinguishing between awake and sleep bruxism.
Measured: Baseline (before dental implant surgery)
Secondary outcomes (1)
Stress Level
The Perceived Stress Scale-14 (PSS-14), developed by Cohen et al. in 1983, was used to assess the level of emotional stress. This self-reported questionnaire comprises 14 items that evaluate the frequency of stress-related thoughts and feelings experienced by the respondent over the past month. Participants rate each item on a four-point Likert scale ranging from "never" to "very often." The total score ranges from 0 to 56, with higher scores indicating greater levels of perceived emotional stress.
Measured: Baseline (before dental implant surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Mar 2025
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülbahar Ustaoğlu, Saglik Bilimleri Universitesi
- Investigators
- GÜLBAHAR USTAOĞLU, Assoc Prof, Principal investigator, GÜLHANE DİŞ HEKİMLİĞİ FAKÜLTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088887
- Sponsor's protocol ID
- BAHAR1
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarac Atagun O, Ceylan Sen S, Ustaoglu G, Sezen I. Assessing patient awareness of bruxism before dental implant therapy. Sci Rep. 2026 Jun 17. doi: 10.1038/s41598-026-56425-5. Online ahead of print.
PubMed 42304024
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bruxism Awareness as a Pre-Treatment Consideration in Dental Implantology
- ClinicalTrials.gov ID
- NCT07088887
- Acronym / sponsor ID
- BAHAR1
- Conditions
- Bruxism
- Keywords
- bruxism, dental implant, Fonseca Anamnestic Index, Perceived Stress Scale-14, awareness.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 28 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.
Bruxism is a parafunctional habit characterized by clenching or grinding of the teeth and/or mandibular thrusting, which may occur during sleep or wakefulness. It is associated with various dental complications, including implant failures. Despite its prevalence, awareness of bruxism among patients remains limited, and diagnostic methods vary. This study aims to evaluate the presence and type of bruxism in patients undergoing dental implant treatment and to assess their awareness levels. The findings may help prevent implant-related complications by supporting early identification and appropriate management of bruxism.
Research Questions What is the prevalence of awake and sleep bruxism in patients scheduled for dental implant treatment?
To what extent are patients aware of their bruxism habits prior to treatment?
What are the most common signs and symptoms of bruxism observed in this patient group?
Is there a correlation between patients' self-reported bruxism and clinical findings?
Can increased bruxism awareness before implant procedures help reduce the risk of future implant and prosthetic complications?
Detailed description
This observational study involves systemically healthy adult patients scheduled for dental implant treatment at a university dental faculty. Clinical examinations were performed to detect characteristic signs of bruxism, and validated self-report tools-including the Bruxism Questionnaire, Fonseca Anamnestic Index, and Perceived Stress Scale-were used to assess both subjective awareness and emotional stress. Additionally, a customized awareness questionnaire was administered to evaluate patients' perceptions and knowledge of bruxism.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bruxism group | – | Other: control groupThe study group included patients aged 18-65 who were systemically healthy and suitable for implant treatment. Collected data covered demographic variables (age, gender), systemic and periodontal health status, and detailed clinical findings. Bruxism was assessed both clinically-based on signs such as masseter hypertrophy and dental wear-and through self-reported questionnaires to determine its type (awake or sleep). Patients also completed the Fonseca Anamnestic Index (FAI) to evaluate temporomandibular disorder (TMD) severity and the Perceived Stress Scale-14 (PSS-14) to assess emotional stress levels. Additionally, a bruxism awareness questionnaire was administered. All evaluations were performed prior to implant surgery using standardized diagnostic forms and validated scales. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of 150 systemically healthy adult patients aged 18 to 65 who applied to the Department of Periodontology at Gülhane Faculty of Dentistry, University of Health Sciences, Ankara, Turkey, between March and June 2025. All participants were seeking dental implant therapy. The sample represents a clinical population attending a tertiary care academic dental center, with diverse educational and socioeconomic backgrounds. Patients with intellectual disabilities, psychiatric disorders, or conditions impairing questionnaire comprehension were excluded. This observational cohort was selected to evaluate the presence of bruxism and patient awareness prior to implant placement.
Key inclusion criteria (3 listed)
- Participants included in the study were individuals aged between 18 and 65 years,
- who were systemically healthy and
- able to comprehend and respond to the questionnaire items
Key exclusion criteria (3 listed)
- Individuals with intellectual disabilities,
- suicidal tendencies, dementia,
- or psychosis were excluded from the study.
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 |
|---|---|---|
| control groupThe control group included patients aged 18-65 who were systemically healthy, had no clinical or self-reported signs of bruxism, and were eligible for implant treatment. Data collected included demographic characteristics (age, gender), systemic and periodontal health status, and clinical examination findings confirming the absence of bruxism. These patients also completed the Fonseca Anamnestic Index (FAI) to assess temporomandibular disorder (TMD) symptoms and the Perceived Stress Scale-14 (PSS-14) to evaluate emotional stress levels. A bruxism awareness questionnaire was also applied to determine baseline knowledge in individuals without bruxism. All assessments were conducted before implant surgery using standardized diagnostic tools. | Other | Bruxism group |
Primary outcome
diagnosis of bruxism
Time frame: Baseline (before dental implant surgery)
Bruxism assessment in this study was based on both clinical examination and self-reported measures. Clinical diagnosis followed the 2018 international consensus criteria, requiring at least two of the following signs: masseter muscle pain or hypertrophy (extraoral), dental wear, linea alba on the buccal mucosa, or recurrent restoration failures (intraoral). Self-reported bruxism was evaluated using a standardized questionnaire based on Lobbezoo et al.'s grading system, distinguishing between awake and sleep bruxism.
1 secondary outcome
Stress Level
Time frame: Baseline (before dental implant surgery)
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 28 Jul 2025.
- Derived from this study: PubMed 42304024Sarac Atagun O, Ceylan Sen S, Ustaoglu G, Sezen I. Assessing patient awareness of bruxism before dental implant therapy. Sci Rep. 2026 Jun 17. doi: 10.1038/s41598-026-56425-5. Online ahead of print.
- 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.
GÜLBAHAR USTAOĞLU, Assoc Prof principal investigator
GÜLHANE DİŞ HEKİMLİĞİ FAKÜLTESİ
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 Bruxism, run by Saglik Bilimleri Universitesi 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 3 inclusion and 3 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 28 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?
diagnosis of bruxism (time frame: Baseline (before dental implant surgery)). 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 NCT07088887, which also lists 1 linked publication.
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 28 Jul 2025.