Clinical Evaluation of ELS Versus ELS Extra Resin Composite

NCT03306576 | Completed DMC

• 1 other identifier: 10840098-604.01.01-E.21426
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Adhesive restorative materials are routinely used in operative dentistry to improve tooth tissues with minimal preparation, achieve more esthetic and long term restorations. Despite these efficacy to dentistry these materials still present some drawbacks like polymerization shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries are often associated with loss of marginal integrity in composite restorations occurred as a result of polymerization shrinkage. To achieve optimal long term performance, the requirements will be first to manage polymerization stress buildup following restoration.Low-shrinking composites with new formulas have been successful in brilliantly further developing the leader product els extra low shrinkage. The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities that needs to be restored in permanent teeth.

Conditions

Caries, Dental

Keywords

composite restoration

Outcome Measures

Primary Outcomes (1)

• Modified FDI criteria

  Restoration failure is based on clinical performance criteria according to the modified FDI criteria

  3 years

Study Arms (2)

ELS Extra composite

EXPERIMENTAL

Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions

Device: ELS Extra composite

ELS composite

ACTIVE COMPARATOR

Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions

Device: ELS composite

Interventions

ELS Extra composite DEVICE

One of the teeth will be restored using ELS composite. Procedures will be done under local anesthesia if necessary. The preparation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.

ELS Extra composite

ELS composite DEVICE

the other teeth will be restored with a ELS resin composite with ordinary restorative techniques.

ELS composite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary caries removal
• Class I \& II restoration replacement
• 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 be-fore 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 hygiene, 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 collection and maintenance and plan to stay in the area for at least 3 years.

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 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
• Saremco: collaborator

Study Sites (1)

Istanbul Medipol University, Dental School

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mutlu Ozcan, Prof Dr,PhD

  University of Zurich, Center for Dental Materials Unit, Center for Fixed and Removable Prosthodontics and Dental Materials Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Model Details: Each participant will receive 2 matched restorations, one of each material.

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 11, 2017
• Study Start: December 10, 2017
• Primary Completion: October 15, 2018
• Study Completion: December 30, 2020
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)