BruxismFibreNCT06870188
Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study
A study testing Composite Restoration and Clinical evaluation in people with Bruxism and Endodontically Treated Molar, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective, randomized, parallel-group clinical study is to compare the 6- and 12-month clinical performances of direct composite restorations applied to endodontically treated posterior teeth with or without the use of fiber-reinforced composite material in individuals with parafunctional habits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Endodontically Treated Molar, Composite Restoration
- What is being tested?
- Composite Restoration and Clinical evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2023to 25 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- Volunteers aged 18 and above Cases where restoration was performed immediately after the completion of root canal treatment on posterior teeth Endodontically treated posterior teeth that required replacement of the old restoration due to secondary caries or fractures Cases without pulpal symptoms Posterior teeth classified as Class 1 and Class 2 according to cavity classification Teeth with a remaining wall thickness of at least 3 mm Presence of parafunction Teeth with a natural tooth in the opposing arch and adjacent teeth on both proximal sides
Who cannot join
- Individuals who are not volunteers
- Cases with ongoing pulpal symptoms
- Posterior teeth with cusp loss
- Teeth with root canal filling that is at least 2 mm shorter than the radiographic apex
- Individuals unable to attend periodic follow-up visits
- Individuals with a Gingival Index score greater than 1
Show all 10Show fewer
- Severe periodontal disease
- Presence of systemic diseases
- Individuals with allergic reactions to any of the materials to be used
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University
Menteşe, Muğla, 48000
About this study
The aim of this prospective, randomized, parallel-group clinical study is to compare the 6- and 12-month clinical performances of direct composite restorations applied to endodontically treated posterior teeth with or without the use of fiber-reinforced composite material in individuals with parafunctional habits.
Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of teeth. The possible outcomes of bruxism include wear and/or fractures in the teeth and restorations. Therefore, the choice of restorative methods and materials for restorations in bruxist individuals is of great importance. Direct adhesive restorations are the first treatment option for endodontically treated teeth with no excessive material loss and/or those that have lost vitality due to trauma. Over the past decade, the use of fiber-reinforced materials has been recommended to prevent catastrophic fractures. Fiber-reinforced materials have been developed and introduced to the market based on the idea that a restorative material that distributes or absorbs stress in high-stress areas will protect the underlying tooth structure.
Read more
Although there are numerous studies on the mechanical durability of restorative treatments for endodontically treated teeth in cases with parafunctional habits, there are limited clinical studies regarding the clinical performance of these methods.
The study included 32 premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups (n=16): Group 1: fiber-reinforced composite restoration (EverX flow, GC) (FRCR), Group 2: composite restoration (Gneal Posterior, GC) (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.
- Being tested
- Composite Restoration, Clinical evaluation
- Keywords
- Fiber reinforced resin composite, composite restoration, endodontically treated teeth, bruxism
- Medical subject headings
- Bruxism, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite RestorationOther
The study included premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). Direct composite restorations with or without fiber reinforced material were applied. The restorations were evaluated at 6 and 12 months using the FDI criteria.
Clinical evaluationOther
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic, and biological criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
| Study group | Role | What they receive |
|---|---|---|
| Fiber-reinforced composite restoration (FRCR) | Experimental | After the cavity preparation, an adhesive was applied to the tooth, and a short fiber-reinforced flowable composite resin (EverX flow, GC) was used as the dentin replacement material. It was then covered with posterior composite resin (Gneal Posterior, GC). Receives: Other: Composite Restoration; Other: Clinical evaluation |
| Composite restoration (CR) | Experimental | After the cavity preparation, an adhesive was applied to the tooth, and only posterior composite resin material (Gneal Posterior, GC) was used for filling whole of the cavity Receives: Other: Composite Restoration; Other: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic and biological criteria according to the FDI criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
Measured: 6 and 12 months-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start31 Jan 2023
- Primary completion21 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included premolar and molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were restored into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT06870188
- Sponsor's protocol ID
- Fiber-reinforced-comp-pilot
- Other IDs
- 23/152/02/3/4
- Acronym
- Fibre
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deliperi S, Bardwell DN. Reconstruction of nonvital teeth using direct fiber-reinforced composite resin: a pilot clinical study. J Adhes Dent. 2009 Feb;11(1):71-8.
PubMed 19343930Meyenberg K. The ideal restoration of endodontically treated teeth - structural and esthetic considerations: a review of the literature and clinical guidelines for the restorative clinician. Eur J Esthet Dent. 2013 Summer;8(2):238-68.
PubMed 23712344Frater M, Forster A, Kereszturi M, Braunitzer G, Nagy K. In vitro fracture resistance of molar teeth restored with a short fibre-reinforced composite material. J Dent. 2014 Sep;42(9):1143-50. doi: 10.1016/j.jdent.2014.05.004. Epub 2014 May 21.
PubMed 24859462Carvalho MA, Lazari PC, Gresnigt M, Del Bel Cury AA, Magne P. Current options concerning the endodontically-treated teeth restoration with the adhesive approach. Braz Oral Res. 2018 Oct 18;32(suppl 1):e74. doi: 10.1590/1807-3107bor-2018.vol32.0074.
PubMed 30365615Yilmaz F, Ozturk Z, Demirbas A, Kursun S. Evaluation of the clinical success of direct restorations of endodontically treated posterior teeth in the presence of parafunction: a 12-month pilot study. Head Face Med. 2025 Oct 10;21(1):70. doi: 10.1186/s13005-025-00546-1.
PubMed 41068790
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study
- ClinicalTrials.gov ID
- NCT06870188
- Acronym / sponsor ID
- Fibre / Fiber-reinforced-comp-pilot
- Keywords
- Fiber reinforced resin composite, composite restoration, endodontically treated teeth, bruxism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 11 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 aim of this prospective, randomized, parallel-group clinical study is to compare the 6- and 12-month clinical performances of direct composite restorations applied to endodontically treated posterior teeth with or without the use of fiber-reinforced composite material in individuals with parafunctional habits.
Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of teeth. The possible outcomes of bruxism include wear and/or fractures in the teeth and restorations. Therefore, the choice of restorative methods and materials for restorations in bruxist individuals is of great importance. Direct adhesive restorations are the first treatment option for endodontically treated teeth with no excessive material loss and/or those that have lost vitality due to trauma. Over the past decade, the use of fiber-reinforced materials has been recommended to prevent catastrophic fractures. Fiber-reinforced materials have been developed and introduced to the market based on the idea that a restorative material that distributes or absorbs stress in high-stress areas will protect the underlying tooth structure.
Although there are numerous studies on the mechanical durability of restorative treatments for endodontically treated teeth in cases with parafunctional habits, there are limited clinical studies regarding the clinical performance of these methods.
The study included 32 premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups (n=16): Group 1: fiber-reinforced composite restoration (EverX flow, GC) (FRCR), Group 2: composite restoration (Gneal Posterior, GC) (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study included premolar and molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were restored into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.
| Arm | Type | Receives |
|---|---|---|
| Fiber-reinforced composite restoration (FRCR) | Experimental | Other: Composite Restoration, Other: Clinical evaluationAfter the cavity preparation, an adhesive was applied to the tooth, and a short fiber-reinforced flowable composite resin (EverX flow, GC) was used as the dentin replacement material. It was then covered with posterior composite resin (Gneal Posterior, GC). |
| Composite restoration (CR) | Experimental | Other: Composite Restoration, Other: Clinical evaluationAfter the cavity preparation, an adhesive was applied to the tooth, and only posterior composite resin material (Gneal Posterior, GC) was used for filling whole of the cavity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers aged 18 and above Cases where restoration was performed immediately after the completion of root canal treatment on posterior teeth Endodontically treated posterior teeth that required replacement of the old restoration due to secondary caries or fractures Cases without pulpal symptoms Posterior teeth classified as Class 1 and Class 2 according to cavity classification Teeth with a remaining wall thickness of at least 3 mm Presence of parafunction Teeth with a natural tooth in the opposing arch and adjacent teeth on both proximal sides
Key exclusion criteria (10 listed)
- Individuals who are not volunteers
- Cases with ongoing pulpal symptoms
- Posterior teeth with cusp loss
- Teeth with root canal filling that is at least 2 mm shorter than the radiographic apex
- Individuals unable to attend periodic follow-up visits
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 |
|---|---|---|
| Composite RestorationThe study included premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). Direct composite restorations with or without fiber reinforced material were applied. The restorations were evaluated at 6 and 12 months using the FDI criteria. | Other | Composite restoration (CR), Fiber-reinforced composite restoration (FRCR) |
| Clinical evaluationThe restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic, and biological criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration. | Other | Composite restoration (CR), Fiber-reinforced composite restoration (FRCR) |
Primary outcome
clinical success
Time frame: 6 and 12 months-follow-up
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic and biological criteria according to the FDI criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
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 11 Mar 2025.
- Background: PubMed 19343930Deliperi S, Bardwell DN. Reconstruction of nonvital teeth using direct fiber-reinforced composite resin: a pilot clinical study. J Adhes Dent. 2009 Feb;11(1):71-8.
- Background: PubMed 23712344Meyenberg K. The ideal restoration of endodontically treated teeth - structural and esthetic considerations: a review of the literature and clinical guidelines for the restorative clinician. Eur J Esthet Dent. 2013 Summer;8(2):238-68.
- Background: PubMed 24859462Frater M, Forster A, Kereszturi M, Braunitzer G, Nagy K. In vitro fracture resistance of molar teeth restored with a short fibre-reinforced composite material. J Dent. 2014 Sep;42(9):1143-50. doi: 10.1016/j.jdent.2014.05.004. Epub 2014 May 21.
- Background: PubMed 30365615Carvalho MA, Lazari PC, Gresnigt M, Del Bel Cury AA, Magne P. Current options concerning the endodontically-treated teeth restoration with the adhesive approach. Braz Oral Res. 2018 Oct 18;32(suppl 1):e74. doi: 10.1590/1807-3107bor-2018.vol32.0074.
- Derived from this study: PubMed 41068790Yilmaz F, Ozturk Z, Demirbas A, Kursun S. Evaluation of the clinical success of direct restorations of endodontically treated posterior teeth in the presence of parafunction: a 12-month pilot study. Head Face Med. 2025 Oct 10;21(1):70. doi: 10.1186/s13005-025-00546-1.
- 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.
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?
A study testing Composite Restoration and Clinical evaluation in people with Bruxism and Endodontically Treated Molar, 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 1 inclusion and 10 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 11 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?
clinical success (time frame: 6 and 12 months-follow-up). 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 NCT06870188, which also lists 5 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 11 Mar 2025.