Clinical trial NCT04756349: Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions
Official title: Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions - A Two Years Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Carious Cervical Lesion
Keywords: adhesives
dental bonding
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized, double-blind clinical trial is to evaluate the clinical performance of non-carious cervicals adhesive restorations using three self-etching adhesives containing HEMA and 10-MDP monomers.

Detailed description: Sixty teeth (n = 20 for each group) will be randomized into 03 groups: Clearfil SE (contains MDP and HEMA), Optibond All-inOne (contains HEMA) and Prime and Bond Universal (contains neither monomer) dispatch). Restorations will be performed by a single operator, and no mechanical retention will be performed under the cavity. After 6, 12 and 24 months, the restorations will be evaluated by two calibrated examiners, using modified USPHS criteria for retention (kappa = 1.00) and adaptation / marginal color (kappa = 0.81), and the results will be analysed by Fisher and Kruskal-Wallis, respectively. An intragroup analysis will be performed using the Cochran test (for retention) and Wilcoxon (for marginal adaptation / staining).

Eligibility criteria: Inclusion Criteria:

* Good oral hygiene
* Absence of periodontal disease
* Presence of at least 02 non-carious cervical lesions

Exclusion Criteria:

* Presence of non-carious cervical lesion in non-vital teeth
* Occlusal instability
* Presence of orthodontic appliance
* Presence of removable partial dental prosthesis
* High risk of caries (presence of three or more active caries lesions)
* Xerostomia
* Bruxism
* Patients allergic to base materials monomers
* Patients who do not accept the project conditions

Primary outcomes:
measure: Retention rate of restoration
timeFrame: 01 year
measure: Retention rate of restoration
timeFrame: 02 years
Secondary outcomes:
measure: Marginal staining rate of restoration
timeFrame: 01 year
measure: Marginal staining rate of restoration
timeFrame: 02 years
measure: Marginal Adaptation rate of restoration
timeFrame: 01 year
measure: Marginal Adaptation rate of restoration
timeFrame: 02 years
Other outcomes:
measure: Postoperative sensitivity rate of restoration
timeFrame: 01 year
measure: Postoperative sensitivity rate of restoration
timeFrame: 02 years
measure: Secondary caries rate of restoration
timeFrame: 01 year
measure: Secondary caries rate of restoration
timeFrame: 02 years
Locations:
city: Belém
country: Brazil
facility: Para's Federal University
state: Pará
Study officials:
affiliation: Federal University of Pará
name: Roberta Oliveira, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pará
name: Brennda De Paula, Msc
role: STUDY_CHAIR
affiliation: Federal University of Pará
name: Cecy Silva, PhD
role: STUDY_DIRECTOR
References: