Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study

NCT06870188 | Completed DMC

• 2 other identifiers: Fiber-reinforced-comp-pilot23/152/02/3/4
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bruxism; Endodontically Treated Molar; Composite Restoration; Fiber Reinforced Composite

Keywords

Fiber reinforced resin composite; composite restoration; endodontically treated teeth; bruxism

Outcome Measures

Primary Outcomes (1)

• 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.

  6 and 12 months-follow-up

Study Arms (2)

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).

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

Other: Composite Restoration; Other: Clinical evaluation

Interventions

Composite Restoration OTHER

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.

Composite restoration (CR); Fiber-reinforced composite restoration (FRCR)

Clinical evaluation OTHER

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.

Composite restoration (CR); Fiber-reinforced composite restoration (FRCR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Severe periodontal disease
• Presence of systemic diseases
• Individuals with allergic reactions to any of the materials to be used
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Sıtkı Koçman University

Menteşe, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 19343930 BACKGROUND

• Meyenberg 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.

  PMID: 23712344 BACKGROUND

• Frater 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.

  PMID: 24859462 BACKGROUND

• Carvalho 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.

  PMID: 30365615 BACKGROUND

• Yilmaz 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.

  PMID: 41068790 DERIVED

MeSH Terms

Conditions

Bruxism; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Dental Pulp Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant professor doctor

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: January 31, 2023
• Primary Completion: February 21, 2025
• Study Completion: February 25, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)