Clinical Evaluation of "Cention Forte" Restorative Material

NCT04796974 | Active Not Recruiting

• 1 other identifier: 365559
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Resin composites, the first choice of material for the restoration of posterior teeth, still have several drawbacks including their polymerization shrinkage and potential failure of the resin-dentin interface leading to secondary caries. Time-saving and simplified restorative procedures are an ongoing demand for posterior applications.The bulk-fill resin based composites (BF-RBCs), has been developed with an attempt to speed up the restoration process by enabling up to 4- or 5-mm thick increments to be cured in one step. The photo-polymerized single-step BF-RBC materials seem to have some limitations in terms of adequate polymerization. Therefore, recently, the use of dual-polymeritzed RBCs that are also suitable for bulk-fill application with additional bioactive properties such as acid-neutralizing ion release has been offered as an alternative to photo-polymerized ones. Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) restorative material is one approach that has been introduced as a new material category for this purpose. The hand mixed form is named as Cention N whereas auto-mixed capsule form is Cention. Both of them are resin based composite materials categorised as 'alkasite'. They are self-curing composites with optional photo-polymerzation for full volume (bulk) placement. Their composition is same with only exception of the concentration of the initiators and the powder liquid proportion. Cention is delivered together with Cention Primer to ensures the retention of the filling independent of the preparation. The objective of this prospective clinical trial is to evaluate the clinical performance of Cention and Cention Primer in restoration of Class I and II cavities.

Conditions

Caries; Unsatisfactory or Defective Restoration of Tooth

Keywords

Restorative materials; Clinical trial; Survival; Alcasites

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.

  3 years

Study Arms (1)

Cention

EXPERIMENTAL

Alcasite restorative material

Device: Cention

Interventions

Cention 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

Cention

Eligibility Criteria

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

You may qualify if:

• Vital tooth checked with sensibility test towards cold
• Proximal and/or occlusal caries lesion to be treated invasively or restoration that needs replacement (i.e. amalgam, composite, glass-ionomer)
• Class I \& II restorations in premolar and molars (at least 75% Class II).
• Maximum 2 fillings with Cention 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) Moderate or high caries activity: DMFS equivalent or higher than mean DMFS of the population of the same age group in the same region or city.
• 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)
• 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
• Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
• Endodontic treatment
• Pulp exposure or near pulp exposure
• Patients who want to bleach their teeth or bleached teeth less than 3 weeks ago
• Extremely hypersensitive tooth (s. below) / Pulpitis 7 VAS (visual analog scale) \>3 on temperature and/or biting
• 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 undergoing orthodontic treatment
• 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 Hospital

Istanbul, 34083, Turkey (Türkiye)

Location

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: Associate Professor

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: March 8, 2021
• Primary Completion: June 8, 2022
• Study Completion: July 8, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)