CompletedNot Applicable

Clinical Evaluation of ELS Versus ELS Extra Resin Composite

Turkey (Türkiye)30 participantsStarted 2017-12-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 clench…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified FDI criteria

Timeframe: 3 years

Trial details

NCT IDNCT03306576

SponsorIstanbul Medipol University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-15

View on ClinicalTrials.gov More Caries, Dental trials