BruxismBruxismNCT06881355
Effect of Bruxism on the Clinical Success of Posterior Composite Restorations
An observational study of Bruxism and Wear, Occlusal, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to determine the effect of bruxism on the success of posterior composite restorations (PCRs) in endodontically treated teeth (ETT). The null hypotheses of present study were as follows: (1) bruxism would not have a significant effect on the success rate of PCRs in ETT; (2) other demographic… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Wear, Occlusal, Fracture
- What is being tested?
- Bruxism diagnosis and Clinical evaluation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 30 Jan 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: In this study, the initial data pool consists of patients who had undergone their first examination and had the necessary radiographs taken routinely. After clinically and radiographically identifying those who had underwent root canal treatment and composite restorations, the eligible participants were included in the study to evaluate their restorations.
Who may be able to join
- Patients aged 18-40 years, PCRs after endodontic treatment,
- Restorations up to 5 years,
- Class 1 and 2 restorations with a maximum of 3 wall loss according to cavity classification and not involving the cusps,
- Patients with low and moderate caries risk, and those with an occlusion classified as Class 1 Angle.
Who cannot join
- Teeth without antagonists;
- patients with crossbite; mobile teeth;
- teeth diagnosed with acute apical/periodontal abscess;
- presence of severe periodontal disease;
- presence of systemic diseases;
- pregnant and breastfeeding women;
Show all 11Show fewer
- patients who had amalgam, post, or indirect methods chosen for definitive restoration after endodontic treatment;
- restorations performed more than 5 years ago;
- patients aged <18 or >40 years;
- restorations involving the cusps,
- patients with high caries risk, and non-dental plaque biofilm-induced gingival diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University
Menteşe, Muğla, 48000
About this study
Official title: Effect of Bruxism on the Clinical Success of Posterior Composite Restorations in Endodontically Treated Teeth: A Cross-sectional, Case-Control Study
The goal of this study is to determine the effect of bruxism on the success of posterior composite restorations (PCRs) in endodontically treated teeth (ETT). The null hypotheses of present study were as follows: (1) bruxism would not have a significant effect on the success rate of PCRs in ETT; (2) other demographic and clinical variations, such as frequency of coloring agent usage, smoking habits, presence of pulpal pathology, periapical lesion, periodontal condition, antagonist tooth condition, cavity margin level, quality of endodontic treatment, enamel cracks, temporomandibular joint (TMJ) disorders, lateral occlusion scheme, institution where the restoration was performed, number of restored surfaces, and follow-up period, would not have a significant effect on the success rate of PCRs in ETT; and (3) functional, esthetic, and biological clinical success of PCRs of bruxists would not differ from that of non-bruxists. This cross-sectional, case-control study included 40 case patients (bruxists with PCR post-ETT) and 40 controls (non-bruxists). Sociodemographic characteristics and clinical findings were recorded. The PCRs on the relevant teeth were evaluated according to the revised FDI criteria.
Read the detailed description
In studies that have conducted long-term follow-ups of posterior composite restorations (PCRs), the most common causes of failure are secondary caries, wear, and fractures. The success of PCRs is influenced by several factors: oral hygiene habits, caries risk, size of the carious lesion, occlusal relationships, presence of parafunctional habits, physical properties of the material used, tooth region in which the restoration is placed, size and location of the restoration, and chewing habits and forces. In addition, the literature suggests that PCRs have a low wear resistance. While this characteristic is considered to offer an advantage in the presence of parafunctional habits, its effect on the success of PCRs under excessive occlusal stress remains a subject of debate. There are many prospective and retrospective studies evaluating the performance of restorations; however, literature on the success of composite resin materials when applied as direct restorations of ETT in patients with bruxism is limited. Furthermore, with the continuous development and introduction of new adhesive techniques and improvements in the composition of composite resin materials, clinical studies need to be updated regularly to assess the performance of restorations.
- Conditions
- Bruxism, Wear, Occlusal, Fracture
- Being tested
- Bruxism diagnosis, Clinical evaluation
- Keywords
- Bruxism, Posterior composite restoration, Clinical success, Endodontically tretaed tooth
- Medical subject headings
- Bruxism, Tooth Attrition, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruxism diagnosisDiagnostic test
The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings.
Clinical evaluationDiagnostic test
The PCRs on the relevant teeth were evaluated according to the revised FDI criteria
| Study group | Role | What they receive |
|---|---|---|
| Case group-Bruxists with PCR post-ETT | Participants having previously undergone endodontic treatment and composite restorations on any of their posterior teeth and bruxism were assigned to the case group. The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings. Receives: Diagnostic Test: Bruxism diagnosis; Diagnostic Test: Clinical evaluation | |
| Control group-Non-bruxists with PCR post-ETT | Participants without bruxism and with PCR post-ETT were assigned to the control group. Receives: Diagnostic Test: Bruxism diagnosis; Diagnostic Test: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Clinical success
FDI scoring system
Measured: 1-5 years-follow up period
Secondary outcomes (1)
% of patients with risk factors
Clinical failure parameter
Measured: 1-5 years-follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start15 Aug 2024
- Primary completion1 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yilmaz, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881355
- Sponsor's protocol ID
- Brux-comp-1
- Other IDs
- MSKU-Resto-Brux-comp-1
- Acronym
- Bruxism
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sociodemographic characteristics and clinical findings
Publications
Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
PubMed 36504246van de Sande FH, Opdam NJ, Rodolpho PA, Correa MB, Demarco FF, Cenci MS. Patient risk factors' influence on survival of posterior composites. J Dent Res. 2013 Jul;92(7 Suppl):78S-83S. doi: 10.1177/0022034513484337. Epub 2013 May 20.
PubMed 23690354Manfredini D, Winocur E, Guarda-Nardini L, Paesani D, Lobbezoo F. Epidemiology of bruxism in adults: a systematic review of the literature. J Orofac Pain. 2013 Spring;27(2):99-110. doi: 10.11607/jop.921.
PubMed 23630682R.R. Moraes, M.S. Cenci, J.R. Moura, F.F. Demarco, B. Loomans, N. Opdam, Clinical performance of resin composite restorations, Curr. Oral Health Rep.9 (2022) 22-31.
Hickel R, Manhart J. Longevity of restorations in posterior teeth and reasons for failure. J Adhes Dent. 2001 Spring;3(1):45-64.
PubMed 11317384Laske M, Opdam NJM, Bronkhorst EM, Braspenning JCC, Huysmans MCDNJM. Risk Factors for Dental Restoration Survival: A Practice-Based Study. J Dent Res. 2019 Apr;98(4):414-422. doi: 10.1177/0022034519827566. Epub 2019 Feb 20.
PubMed 30786222Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.
PubMed 26525008Koyano K, Tsukiyama Y, Ichiki R, Kuwata T. Assessment of bruxism in the clinic. J Oral Rehabil. 2008 Jul;35(7):495-508. doi: 10.1111/j.1365-2842.2008.01880.x.
PubMed 18557916Yilmaz F, Dorterler OC. Effect of Bruxism on the Clinical Success of Posterior Composite Restorations in Endodontically Treated Teeth: A Cross-Sectional, Case-Control Study. J Esthet Restor Dent. 2025 Oct;37(10):2180-2192. doi: 10.1111/jerd.70008. Epub 2025 Jul 27.
PubMed 40717393
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bruxism on the Clinical Success of Posterior Composite Restorations in Endodontically Treated Teeth: A Cross-sectional, Case-Control Study
- ClinicalTrials.gov ID
- NCT06881355
- Acronym / sponsor ID
- Bruxism / Brux-comp-1
- Conditions
- Bruxism, Wear, Occlusal, Fracture
- Keywords
- Bruxism, Posterior composite restoration, Clinical success, Endodontically tretaed tooth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 18 Mar 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.
The goal of this study is to determine the effect of bruxism on the success of posterior composite restorations (PCRs) in endodontically treated teeth (ETT). The null hypotheses of present study were as follows: (1) bruxism would not have a significant effect on the success rate of PCRs in ETT; (2) other demographic and clinical variations, such as frequency of coloring agent usage, smoking habits, presence of pulpal pathology, periapical lesion, periodontal condition, antagonist tooth condition, cavity margin level, quality of endodontic treatment, enamel cracks, temporomandibular joint (TMJ) disorders, lateral occlusion scheme, institution where the restoration was performed, number of restored surfaces, and follow-up period, would not have a significant effect on the success rate of PCRs in ETT; and (3) functional, esthetic, and biological clinical success of PCRs of bruxists would not differ from that of non-bruxists. This cross-sectional, case-control study included 40 case patients (bruxists with PCR post-ETT) and 40 controls (non-bruxists). Sociodemographic characteristics and clinical findings were recorded. The PCRs on the relevant teeth were evaluated according to the revised FDI criteria.
Detailed description
In studies that have conducted long-term follow-ups of posterior composite restorations (PCRs), the most common causes of failure are secondary caries, wear, and fractures. The success of PCRs is influenced by several factors: oral hygiene habits, caries risk, size of the carious lesion, occlusal relationships, presence of parafunctional habits, physical properties of the material used, tooth region in which the restoration is placed, size and location of the restoration, and chewing habits and forces. In addition, the literature suggests that PCRs have a low wear resistance. While this characteristic is considered to offer an advantage in the presence of parafunctional habits, its effect on the success of PCRs under excessive occlusal stress remains a subject of debate. There are many prospective and retrospective studies evaluating the performance of restorations; however, literature on the success of composite resin materials when applied as direct restorations of ETT in patients with bruxism is limited. Furthermore, with the continuous development and introduction of new adhesive techniques and improvements in the composition of composite resin materials, clinical studies need to be updated regularly to assess the performance of restorations.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group-Bruxists with PCR post-ETT | – | Diagnostic Test: Bruxism diagnosis, Diagnostic Test: Clinical evaluationParticipants having previously undergone endodontic treatment and composite restorations on any of their posterior teeth and bruxism were assigned to the case group. The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings. |
| Control group-Non-bruxists with PCR post-ETT | – | Diagnostic Test: Bruxism diagnosis, Diagnostic Test: Clinical evaluationParticipants without bruxism and with PCR post-ETT were assigned to the control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In this study, the initial data pool consists of patients who had undergone their first examination and had the necessary radiographs taken routinely. After clinically and radiographically identifying those who had underwent root canal treatment and composite restorations, the eligible participants were included in the study to evaluate their restorations.
Key inclusion criteria (4 listed)
- Patients aged 18-40 years, PCRs after endodontic treatment,
- Restorations up to 5 years,
- Class 1 and 2 restorations with a maximum of 3 wall loss according to cavity classification and not involving the cusps,
- Patients with low and moderate caries risk, and those with an occlusion classified as Class 1 Angle.
Key exclusion criteria (11 listed)
- Teeth without antagonists;
- patients with crossbite; mobile teeth;
- teeth diagnosed with acute apical/periodontal abscess;
- presence of severe periodontal disease;
- presence of systemic diseases;
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 |
|---|---|---|
| Bruxism diagnosisThe presence of bruxism was determined based on the participant's self-reported statements and intraoral findings. | Diagnostic test | Case group-Bruxists with PCR post-ETT, Control group-Non-bruxists with PCR post-ETT |
| Clinical evaluationThe PCRs on the relevant teeth were evaluated according to the revised FDI criteria | Diagnostic test | Case group-Bruxists with PCR post-ETT, Control group-Non-bruxists with PCR post-ETT |
Primary outcome
Rate of Clinical success
Time frame: 1-5 years-follow up period
FDI scoring system
1 secondary outcome
% of patients with risk factors
Time frame: 1-5 years-follow up period
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 18 Mar 2025.
- Background: PubMed 36504246Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
- Background: PubMed 23690354van de Sande FH, Opdam NJ, Rodolpho PA, Correa MB, Demarco FF, Cenci MS. Patient risk factors' influence on survival of posterior composites. J Dent Res. 2013 Jul;92(7 Suppl):78S-83S. doi: 10.1177/0022034513484337. Epub 2013 May 20.
- Background: PubMed 23630682Manfredini D, Winocur E, Guarda-Nardini L, Paesani D, Lobbezoo F. Epidemiology of bruxism in adults: a systematic review of the literature. J Orofac Pain. 2013 Spring;27(2):99-110. doi: 10.11607/jop.921.
- BackgroundR.R. Moraes, M.S. Cenci, J.R. Moura, F.F. Demarco, B. Loomans, N. Opdam, Clinical performance of resin composite restorations, Curr. Oral Health Rep.9 (2022) 22-31.
- Background: PubMed 11317384Hickel R, Manhart J. Longevity of restorations in posterior teeth and reasons for failure. J Adhes Dent. 2001 Spring;3(1):45-64.
- Background: PubMed 30786222Laske M, Opdam NJM, Bronkhorst EM, Braspenning JCC, Huysmans MCDNJM. Risk Factors for Dental Restoration Survival: A Practice-Based Study. J Dent Res. 2019 Apr;98(4):414-422. doi: 10.1177/0022034519827566. Epub 2019 Feb 20.
- Background: PubMed 26525008Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.
- Background: PubMed 18557916Koyano K, Tsukiyama Y, Ichiki R, Kuwata T. Assessment of bruxism in the clinic. J Oral Rehabil. 2008 Jul;35(7):495-508. doi: 10.1111/j.1365-2842.2008.01880.x.
- Derived from this study: PubMed 40717393Yilmaz F, Dorterler OC. Effect of Bruxism on the Clinical Success of Posterior Composite Restorations in Endodontically Treated Teeth: A Cross-Sectional, Case-Control Study. J Esthet Restor Dent. 2025 Oct;37(10):2180-2192. doi: 10.1111/jerd.70008. Epub 2025 Jul 27.
- Individual participant dataSharing planned: Yes. sociodemographic characteristics and clinical findings
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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 Bruxism and Wear, Occlusal, run by Muğla Sıtkı Koçman University 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 4 inclusion and 11 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 18 Mar 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?
Rate of Clinical success (time frame: 1-5 years-follow up period). 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 NCT06881355, which also lists 9 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 18 Mar 2025.