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

Non Carious Cervical Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756349
• Other study ID #: UFPara
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: February 12, 2022

Study information

• Verified date: May 2022
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 12, 2022
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Carious Cervical Lesion
• Uterine Cervical Diseases

Intervention

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.

Locations

Country	Name	City	State
Brazil	Para's Federal University	Belém	Pará

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative sensitivity rate of restoration	present or absent	01 year
Other	Postoperative sensitivity rate of restoration	present or absent	02 years
Other	Secondary caries rate of restoration	present or absent	01 year
Other	Secondary caries rate of restoration	present or absent	02 years
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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