Clinical trial NCT05751382: Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs
Official title: 3-year Evaluation of the Clinical Performances of a Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin Used for Direct Restorations of Non-carious Cervical Lesions (NCCLs): A Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tooth Restoration
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2023-03-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design, i.e. each subject have both treatment arms.
Primary purpose: TREATMENT

Brief summary: This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). The study consists of a 3-year long follow-up period.

Detailed description: The aim of this study is to demonstrate non-inferiority in terms of clinical performance and patient discomfort after direct restorative treatment of class V NCCL with Surefil one restorative material (Dentsply Sirona) in combination with a traditional paste composite "Venus Pearl" employed in combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.

Eligibility criteria: Inclusion Criteria:

* Patients aging from 18 to 70
* 40-60% women, 40-60% men
* Patients who present at least 2 cervical lesions on canines and / or upper premolars on vital teeth
* Patients who are not allergic or sensitive to the ingredients contained in the products
* The test patient consents to the restorative treatment in line with the study´s criteria (informed consent)
* Sufficiently understanding of the language

Exclusion Criteria:

* Extremely low level of oral hygiene
* Teeth with previous restorations
* Not possible adequate isolation of the operating area
* Patients with serious systemic diseases
* Devitalized teeth or with pulpitis in progress
* Periodontal problems on the elements to be restored

Primary outcomes:
measure: Assessment of Restorative Quality
timeFrame: At 36 months follow-up.
measure: Assessment of Restorative Quality
timeFrame: At 36 months follow-up
Secondary outcomes:
measure: Assessment of Restorative Quality
timeFrame: At 6, 12 and 24 months follow-up
measure: Assessment of Restorative Quality
timeFrame: At 6, 12 and 24 months follow-up
measure: Assessment of Aesthetics
timeFrame: At 6, 12, 24 and 36 months follow-up
measure: Level of Pain
timeFrame: At 6, 12, 24 and 36 months follow-up
Other outcomes:
measure: Time Needed to Perform the Restoration
timeFrame: Day 0
Locations:
city: Bologna
country: Italy
facility: Clinica Odontoiatrica (DIBINEM)
Study officials:
affiliation: Clinica Odontoiatrica (DIBINEM)
name: Lorenzo Breschi, Prof
role: PRINCIPAL_INVESTIGATOR
References: