Clinical Evaluation of Basic Filling Material in Class I and II Posterior Restorations

NCT02763085 | Completed DMC

• 1 other identifier: 283 (108400987-308)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of a new basic filling restorative material. In contemporary dentistry, clinicians have essentially three types of material choices for direct restorations: amalgam, resin composite, and glass ionomer restoratives. Due to the toxicity of mercury and the subsequent environmental problems, the search for alternatives continues and search into new composite restorative materials intensifies. Recognized disadvantages of tooth colored resin based restorative materials are as polymerization shrinkage, postoperative sensitivity and technical procedure complexity. Higher rates of occlusal wear and lower toughness are disadvantages of glass ionomer restoratives. Therefore, alternative materials are being developed to compensate the disadvantages of current contemporary tooth coloured restorative materials. Nevertheless, the search for simplification for restoring missing dental tissues introduced the "basic filling concept". This project aims to study the clinical performance of this new basic filling restorative material for Class I and Class II cavities. 80 patients are recruited to the project which is carried out at the School of dentistry, Istanbul Medipol University, Turkey.

Conditions

Caries; Unsatisfactory Restoration of Tooth

Outcome Measures

Primary Outcomes (1)

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

  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.

  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)

Basic Filling Material

EXPERIMENTAL

Fillings made with a new dental filling material.

Device: Basic Filling Material

Interventions

Basic Filling Material DEVICE

Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques.

Also known as: Dental Filling

Basic Filling Material

Eligibility Criteria

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

You may qualify if:

• Vital tooth
• Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer)
• Class I \& II restorations premolar and molars
• Maximum 2 fillings with the Basic Filling material in each patient
• 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 be over the age of 18, 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)

You may not qualify if:

• 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
• Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
• Excluding the teeth, without 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 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 School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

Study Officials

• Emir Yuzbasioglu, DDS,PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Mutlu Ozcan, 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: Dr.

Study Record Dates

• First Submitted: February 14, 2016
• First Posted: May 5, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2020
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)