Clinical trial NCT06870188: Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study
Official title: Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism
Endodontically Treated Molar
Composite Restoration
Fiber Reinforced Composite
Keywords: Fiber reinforced resin composite
composite restoration
endodontically treated teeth
bruxism
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: clinical success
timeFrame: 6 and 12 months-follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Mentese
country: Turkey
facility: Muğla Sıtkı Koçman University
state: Mugla
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.