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

NCT04756349 | Completed DMC

• 1 other identifier: UFPara
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Carious Cervical Lesion

Keywords

adhesives; dental bonding

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Marginal staining rate of restoration

  01 year

• Marginal staining rate of restoration

  02 years

• Marginal Adaptation rate of restoration

  01 year

• Marginal Adaptation rate of restoration

  02 years

Other Outcomes (4)

• Postoperative sensitivity rate of restoration

  01 year

• Postoperative sensitivity rate of restoration

  02 years

• Secondary caries rate of restoration

  01 year

Study Arms (3)

Clearfil SE

ACTIVE COMPARATOR

Group containing 10-MDP and HEMA monomers

Other: composite resin restoration

Optibond All-in-One

ACTIVE COMPARATOR

Group containing HEMA monomer

Other: composite resin restoration

Prime & Bond Universal

ACTIVE COMPARATOR

Control Group containing other monomers

Other: composite resin restoration

Interventions

composite resin restoration OTHER

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.

Also known as: composite resin restorations with Clearfil SE adhesive, composite resin restorations with Optibond All-in-One adhesive, composite resin restorations with Prime & Bond Universal adhesive

Clearfil SE; Optibond All-in-One; Prime & Bond Universal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Para's Federal University

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Interventions

PRIME protocol

Study Officials

• Roberta Oliveira, Msc

  Federal University of Pará

  PRINCIPAL INVESTIGATOR

• Brennda De Paula, Msc

  Federal University of Pará

  STUDY CHAIR

• Cecy Silva, PhD

  Federal University of Pará

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 16, 2021
• Study Start: February 12, 2020
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)