Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions

Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions - A Two Years Randomized Double Blind Study

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.

Study Overview

• Status: Completed
• Conditions: Non Carious Cervical Lesion
• Intervention / Treatment: Other: composite resin restoration

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).

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pará
    • Belém, Pará, Brazil, 66075-110
      • Para's Federal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clearfil SE; Group containing 10-MDP and HEMA monomers	Other: composite resin restoration; All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime & Bond Universal.; Other Names: composite resin restorations with Clearfil SE adhesive; composite resin restorations with Optibond All-in-One adhesive; composite resin restorations with Prime & Bond Universal adhesive
Active Comparator: Optibond All-in-One; Group containing HEMA monomer	Other: composite resin restoration; All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime & Bond Universal.; Other Names: composite resin restorations with Clearfil SE adhesive; composite resin restorations with Optibond All-in-One adhesive; composite resin restorations with Prime & Bond Universal adhesive
Active Comparator: Prime & Bond Universal; Control Group containing other monomers	Other: composite resin restoration; All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime & Bond Universal.; Other Names: composite resin restorations with Clearfil SE adhesive; composite resin restorations with Optibond All-in-One adhesive; composite resin restorations with Prime & Bond Universal adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate of restoration	The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss.	01 year
Retention rate of restoration	The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss.	02 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal staining rate of restoration	The marginal staining rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no staining. Bravo = superficial staining (localized or generalized). Charlie = deep staining (localized or generalized).	01 year
Marginal staining rate of restoration	The marginal staining rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no staining. Bravo = superficial staining (localized or generalized). Charlie = deep staining (localized or generalized).	02 years
Marginal Adaptation rate of restoration	The marginal adaptation rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no visible evidence of a crack along the edge, the explorer will not penetrate. Bravo = visible evidence of a crack along the margin, dentin unexposed, clinically acceptable. Charlie = explorer penetrates the crack, dentin exposed, clinically unacceptable.	01 year
Marginal Adaptation rate of restoration	The marginal adaptation rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no visible evidence of a crack along the edge, the explorer will not penetrate. Bravo = visible evidence of a crack along the margin, dentin unexposed, clinically acceptable. Charlie = explorer penetrates the crack, dentin exposed, clinically unacceptable.	02 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative sensitivity rate of restoration	present or absent	01 year
Postoperative sensitivity rate of restoration	present or absent	02 years
Secondary caries rate of restoration	present or absent	01 year
Secondary caries rate of restoration	present or absent	02 years

Collaborators and Investigators

• Sponsor: Universidade Federal do Para
• Investigators: Principal Investigator: Roberta Oliveira, Msc, Federal University of Pará; Study Chair: Brennda De Paula, Msc, Federal University of Pará; Study Director: Cecy Silva, PhD, Federal University of Pará

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 12, 2022

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: adhesives; dental bonding
• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: UFPara

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No