Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population

NCT06275581 | Terminated DMC

• 1 other identifier: CR15_15 (EM-11-050055)
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment. STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTS Primary Endpoint: 1\. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.) Secondary Endpoints:

• regarding overall survival
• regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M)
• regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients. Treatment: After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration. Evaluation periods: All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria)
• at baseline at day of restoration placement or up to 1 month after restoration placement
• after 6 months (± 1 months)
• after 1 year (± 1 months)
• after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation. In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline.

Conditions

Tooth Wear; Glass Ionomer Cements

Keywords

tooth wear; dental restoration; dental impression

Outcome Measures

Primary Outcomes (1)

• Restoration survival over time based on the glass ionomer restoration criteria

  Restoration survival is defined as following: A restoration is classified as "survival" if it has received score 1 through 3 in all categories. In case of non-acceptable performance (score 4 or score 5 in one or more of the glass ionomer restoration criteria -simplified FDI criteria- the restoration is classified as a failure. The Clinical Performance Criteria for Posterior Glass Ionomer Restorations -simplified FDI criteria- scores the following aspects: Retention, Fractures / Marginal Chipping, Surface / Marginal Staining, Wear, Postoperative Sensitivity / Vitality, Caries Associated with Restoration (CAR), Tooth Integrity (enamel cracks / tooth fracture). The Evaluation periods for the FDI criteria were: at baseline at day of restoration placement or up to 1 month after restoration placement, after 6 months (± 1 months), after 1 year (± 1 months), after 2 years (± 1 months).

  1-24 months

Secondary Outcomes (3)

• Evaluation of restoration quality based on the glass ionomer restoration criteria

  1-24 months

• Evaluation of restoration wear based on comparison of digital impressions

  1-24 months

• Safety Endpoint: The safety endpoint is the incidence of Adverse Events.

  1-24months

Study Arms (2)

Ketac Universal test group

EXPERIMENTAL

intra-individual (split-mouth) study

Device: Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group)

Ketac Molar Quick control group

ACTIVE COMPARATOR

intra-individual (split-mouth) study

Device: Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group)

Interventions

Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group) DEVICE

Ketac Universal Aplicap Glass Ionomer Restorative (test group) was applied in one cavity of the patient, randomized allocated, in a stress bearing Class II restoration when the isthmus was less than half of the intercuspal distance and with at least one occlusal contact on enamel of the restored tooth. This material does not require a cavity conditioning step prior to restoration placement.

Ketac Universal test group

Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group) DEVICE

Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group) was applied in the other cavity of the patient,randomized allocated, in a stress bearing Class II restoration when the isthmus was less than half of the intercuspal distance and with at least one occlusal contact on enamel of the restored tooth.

Ketac Molar Quick control group

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 18 and 70 years of age
• Subject is in good general health
• Subject does not have known allergies against any study substances
• Subject is in need of a Class II restoration on at least 2 teeth (stress bearing, isthmus less than half of intercuspal distance, no cusp replacement)
• Both study teeth must have a good prognosis for the next 5 years (no increased tooth mobility, periodontal probing depth is ≤5 mm, no signs of pulpitis, no pulp exposure during treatment, tooth is vital, level of oral hygiene is sufficient)
• Both study restorations are not in contact to each other
• Subject does not suffer from bruxism or from traumatic malocclusion
• Study tooth must have one enamel supported antagonistic contact outside the restoration area
• Each study restoration has at least one proximal contact and is stress bearing
• Subject does not have excessive dietary or environmental exposure to acids or suffer from eating disorders
• Subject is not pregnant or breast feeding
• Subject volunteers to participate in the study and is available for recalls during the 5 years study duration
• Subject does not participate in any other study

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• 3M: collaborator

Study Sites (1)

Dental Health Clinic at Universidad Europea de Madrid (UEM) Department of Prosthodontics

Madrid, 28045, Spain

Location

Related Publications (1)

• Urcelay Moreno N, Bertuol Gessi SF, Benabdallah M'Rabat M, Thuissard IJ, Santamaria-Laorden A. In vivo prospective randomised study of the wear of dental restorations using an intraoral scanner and its correlation with visual assessment. J Dent. 2025 Feb;153:105471. doi: 10.1016/j.jdent.2024.105471. Epub 2024 Nov 26.

  PMID: 39603331 DERIVED

MeSH Terms

Conditions

Tooth Wear

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 23, 2024
• Study Start: June 14, 2017
• Primary Completion: March 24, 2021
• Study Completion: October 1, 2021
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)