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Completed

NCT Number: NCT04756349

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

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.

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Key information

Conditions

Non Carious Cervical Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Para's Federal University

Belém, Pará, 66075-110, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Retention rate of restoration

    Time frame: 01 year

    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.

  2. Retention rate of restoration

    Time frame: 02 years

    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.

Secondary outcomes

  1. Marginal staining rate of restoration

    Time frame: 01 year

    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).

  2. Marginal staining rate of restoration

    Time frame: 02 years

    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).

  3. Marginal Adaptation rate of restoration

    Time frame: 01 year

    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.

  4. Marginal Adaptation rate of restoration

    Time frame: 02 years

    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.

Other outcomes

  1. Postoperative sensitivity rate of restoration

    Time frame: 01 year

    present or absent

  2. Postoperative sensitivity rate of restoration

    Time frame: 02 years

    present or absent

  3. Secondary caries rate of restoration

    Time frame: 01 year

    present or absent

  4. Secondary caries rate of restoration

    Time frame: 02 years

    present or absent

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 16, 2021
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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