Clinical Evaluation of Posterior Indirect Resin Composite Restorations With PBE

NCT03832829 | Unknown DMC

• 1 other identifier: 10840098-604.01.01-E.34133
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of posterior indirect resin composite restorations with proximal box elevation technique. Restoration of large posterior defects extending below the cemento-enamel junction (CEJ) with coverage of one or more cusps represent a very common clinical situation. When restoring deep cervical margins biological and technical operative problems may occur. In order to make clinical procedures less fault-prone 'Proximal Box Elevation' (PBE) is an option that refers to application of composite resin in the deepest parts of the proximal areas in order to reposition the cervical margin supragingivally prior to cavity preparation for an indirect restoration. This project aims to evaluate the clinical performance and periodontal status of posterior indirect composite restorations with PBE. According to study design at least 60 patients will be recruited to project and 80 restorations will be evaluated. The project will be carried out at the School of Dentistry, Istanbul Medipol University,Turkey.

Conditions

Unsatisfactory or Defective Restoration of Tooth

Outcome Measures

Primary Outcomes (1)

• FDI (World Dental Federation) criteria for dental restorations assessment

  Two independent investigators are responsible for evaluations. The primary outcome will consist in the FDI (World Dental Federation) instruments for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually. The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.

  at 3 years

Secondary Outcomes (2)

• Plaque accumulation according to the Silness & Löe (1964) Plaque Index:

  at 3 years

• Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.

  at 3 years

Study Arms (1)

Indirect restorations with SR Nexco

EXPERIMENTAL

Large posterior defects with at least one or more cuspal coverage in molars will be restored using the materials listed (SR Nexco). Procedures will be done using local anesthesia. The procedure, starts with removal of caries or defective restorations and coronal relocation of the the margins using flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite build-up. Defined principles of morphology driven preparation technique will be followed Impression making, fabrication of indirect restoration with SR Nexco and adhesive cementation will be completed according to manufacturer's instructions.

Device: Indirect composite restoration

Interventions

Indirect composite restoration DEVICE

Restoration of tooth with extensive substance loss

Also known as: Onlay and overlay restoration

Indirect restorations with SR Nexco

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Vital or endodontically treated posterior teeth with extensive substance loss
• Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer)
• Large posterior defects with at least one or more cuspal coverage in molars
• Proximal defects extending below CEJ and at least one or more cavity margin/margins located beneath the gingival tissues
• Maximum 2 indirect restorations with SR Nexco material in each patient
• No obvious untreated caries in the rest of the dentition, dental health problems (regularly checked by a dentist)
• Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment)
• No untreated periodontal disease (only DPSI 1, 2)
• Subjects had to be over 18 years of age, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with moderate to good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
• Appropriate isolation after cavity preparations
• Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.

You may not qualify if:

• Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3 2. Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
• Poor endodontic prognosis
• Pulp exposure
• Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
• Extremely hypersensitive tooth
• Excluding the teeth, without opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
• Substance loss due to developmental anomalies (hypoplasia, amelogenesis imperfecta etc.)
• Subjects who presented severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
• Subjects who are pregnant or breast feeding during the duration of the study
• Subjects who are known to be allergic to the ingredients of resin materials

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Ivoclar Vivadent AG: collaborator

Study Sites (1)

Istanbul Medipol University, Dental School

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (6)

• Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.

  PMID: 20847997 BACKGROUND

• Juloski J, Koken S, Ferrari M. Cervical margin relocation in indirect adhesive restorations: A literature review. J Prosthodont Res. 2018 Jul;62(3):273-280. doi: 10.1016/j.jpor.2017.09.005. Epub 2017 Nov 15.

  PMID: 29153552 RESULT

• D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22.

  PMID: 23695612 RESULT

• Dukic W, Dukic OL, Milardovic S, Delija B. Clinical evaluation of indirect composite restorations at baseline and 36 months after placement. Oper Dent. 2010 Mar-Apr;35(2):156-64. doi: 10.2341/09-133-C.

  PMID: 20420058 RESULT

• Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76.

  PMID: 20305873 RESULT

• Aksaka N, Gozetici-Cil B, Ozcan M. Periodontal status of indirect resin composite restorations with proximal box elevation: 3-year clinical results. Clin Oral Investig. 2025 Nov 29;29(12):593. doi: 10.1007/s00784-025-06676-9.

  PMID: 41317197 DERIVED

MeSH Terms

Interventions

Inlays

Intervention Hierarchy (Ancestors)

Dental Restoration, Permanent; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Mutlu Özcan, DDS,PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: A prospective clinical trial

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 6, 2019
• Study Start: September 11, 2018
• Primary Completion: September 14, 2022
• Study Completion: September 1, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)