Clinical Evaluation of SI-R21204 Versus Nano-hybrid Resin Composite: A Prospective Controlled Clinical Trial

NCT02823769 | Completed

• 1 other identifier: 3215
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the advances in adhesive restorative techniques and materials, dental caries still remains a critical concern even today. In addition, recurrent caries related to microleakage is a common mode of failure of directly placed resin composite restorations. Resin composites are particularly susceptible to recurrent caries due to polymerization contraction and also imperfect adhesion of restorative to tooth tissue. Thus, strong durable bond between adhesive restoratives and tooth tissue and increasing the resistance of teeth to acid by encouraging the development of remineralization are essential to withstand secondary caries. Fluoride has been documented as a major contributing factor for the decline in the incidence of dental caries and also it has been accepted as an agent in the prevention of caries. Giomers are a new group of anhydrous resin based direct adhesive restorative materials based on the filler technology (PRG) have both advantages of glass ionomers namely, fluoride release and recharge, and resin composites with excellent optical and mechanical properties. The chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower incidence of recurrent caries that was accepted as a major factor to retreat a resin restoration. Limited number of studies is available on their fluoride release, and polishability, as well as clinical survival. The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material "SI-R21204 resin composite" versus a "nano-hybrid resin com-posite" materials for Class I and Class II cavities that needs to be restored in per-manent teeth.40 patients are recruited to the project which is carried out at the School of dentistry, Istanbul Medipol University, Turkey.

Conditions

Caries

Keywords

clinical study; dental fillings

Outcome Measures

Primary Outcomes (1)

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

  2 independent evaluators The primary outcome will consist in the FDI (World Dental Federation) instrument 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. Hickel R, Peschke A, Tyas M, Mjör 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. Clin Oral Investig. 2010 Aug;14(4):349-66.

  3 years

Secondary Outcomes (2)

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

  3 years

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

  3 years

Study Arms (2)

SI-R21204 resin composite

EXPERIMENTAL

Fillings made with a new dental filling material

Device: SI-R21204 resin composite

Nanohybrid resin composite

ACTIVE COMPARATOR

Fillings made with nanohybrid resin composite (Clearfil Majesty)

Device: Nanohybrid resin composite

Interventions

SI-R21204 resin composite DEVICE

Primary caries of posterior teeth will be restored using SI-R21204 resin composite. Procedures will be done under local anesthesia if necessary. The preperation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.

SI-R21204 resin composite

Nanohybrid resin composite DEVICE

One of the cavities will be restored with a nanohybrid resin composite (Clearfil Majesty) as a control restoration wth ordinary restorative techniques.

Nanohybrid resin composite

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary caries removal
• Class I \& II restorations
• No obvious untreated caries, 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 present no active carious lesions
• Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hy-giene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
• Subjects had to agree to keep the scheduled recall appointments for data collec-tion and maintenance and plan to stay in the area for at least 3 years.

You may not qualify if:

• Composite or amalgam removal
• Caries extends cemento-enamel junction in Class II.
• Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3
• Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
• Endodontic treatment with extensive loss of tooth tissue
• Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
• Excluding the teeth, with opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
• Subjects who presented with severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
• Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
• Subjects who were pregnant pregnant 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
• Shofu Inc.: collaborator

Study Sites (1)

Istanbul Medipol University School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (1)

• Toz-Akalin T, Ozturk-Bozkurt F, Kusdemir M, Ozsoy A, Yuzbasioglu E, Ozcan M. Three-year clinical performance of direct restorations using low-shrinkage Giomer vs. nano-hybrid resin composite. Front Dent Med. 2024 Oct 9;5:1459473. doi: 10.3389/fdmed.2024.1459473. eCollection 2024.

  PMID: 39917677 DERIVED

Study Officials

• Emir Yuzbasioglu, DDS,PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Mutlu Özcan, DDS,PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 6, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: August 16, 2020
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)