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Dentin Treatments for Restorations of Cervical Lesions Non-Carious

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434601
Recruitment Status : Unknown
Verified April 2015 by Rafael Guerra Lund, Federal University of Pelotas.
Recruitment status was:  Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Rafael Guerra Lund, Federal University of Pelotas

Brief Summary:
The surface of non-carious cervical lesions (LCNC) is a challenge to adhesive systems, it presents a dentin layer sclera hypermineralized, presence of bacteria and lack of mechanical retention, so this study aimed to evaluate the influence of different surface treatments on LCNC through a randomized clinical trial. Patients with LCNC were referred to the study and selected according to the inclusion criteria, such as the presence of at least 3 LCNC. Three different types of surface treatment were carried out in LCNC: control group, 15 seconds of etching dentin; Group I, acid etching of dentin in 30 seconds; and group II, cavity prophylaxis with ultrasound for 30 seconds. The remaining steps of the adhesive and restorative procedure was the same for all groups, following the material manufacturer's recommendations. Evaluations of restorations will be carried out in periods of one week (baseline), six months, one year, two years and three years as of tooth sensitivity, integrity and color change. Data will be analyzed by McNemar and chi-square test.

Condition or disease Intervention/treatment Phase
Adhesion Procedure: Treatment of Dentin Surface Procedure: Dentin Surface Procedure: Treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dentin Treatments for Restorations of Cervical Lesions Non-carious: a Randomized Clinical Trial of Three Years
Study Start Date : March 2011
Actual Primary Completion Date : March 2013
Estimated Study Completion Date : October 2016

Arm Intervention/treatment
Treatment of Dentin Surface
Treatment of Dentin Surface: Restoration made following the protocol recommended by the manufacturer of the materials.
Procedure: Treatment of Dentin Surface
  • Experimental Group 1: Increase the etching time to 30 seconds, performed with phosphoric acid gel at 37%, prior to application of the resin adhesive.
  • Experimental Group 2: Prophylaxis cavity probe / blunt tip of ultrasound, applied for 30 seconds on the dentin surface hypermineralized of cervical lesions non-carious.

Both restorative procedures were performed using a conventional adhesive system and composite restorative nanoparticulate.

Other Name: Preconditioning of Dental Surface

Experimental: Dentin Surface
Treatment of Dentin Surface: Increased etching dentin for 15 seconds to 30 seconds
Procedure: Dentin Surface
Treatment of Dentin Surface: Increased etching dentin for 15 seconds to 30 seconds

Experimental: Treatment
Treatment of Dentin Surface: Intervention with the cavity prophylaxis probe ultrasound blunt applied for 30 seconds in Surface hypermineralized non-carious dentin cervical lesions. Therefore, the restoration was done following the protocol recommended by the manufacturer of the material.
Procedure: Treatment
Treatment of Dentin Surface: Intervention with the cavity prophylaxis probe ultrasound blunt applied for 30 seconds in Surface hypermineralized non-carious dentin cervical lesions. Therefore, the restoration was done following the protocol recommended by the manufacturer of the material.




Primary Outcome Measures :
  1. Number of teeth with lost restorations [ Time Frame: From Baseline restorations at 3 years ]

Secondary Outcome Measures :
  1. Presence or not of marginal leakage [ Time Frame: From Baseline restorations at 3 years ]
  2. Presence or not of dentin hypersensitivity [ Time Frame: From Baseline restorations at 3 years ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presence of at least three non-carious cervical lesions on the buccal aspect of previous vital teeth or premolars;
  • Visible plaque index presence and / or gingival bleeding index of at most 20%;
  • Probing depth of at least 3 mm in the experimental site and / or buccal 4 mm in any place;
  • Patients with good general health condition;
  • Patients able to understand and sign the letter of information and the free and informed consent;
  • Patients willing to return every six months to revaluation queries.

Exclusion Criteria:

  • Presence of less than 20 teeth in the mouth;
  • Patients undergoing orthodontic treatment;
  • Patients with occlusion problems;
  • Veneers with wear over 50% of the incisal / occlusal structure;
  • Absence of tooth antagonist.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434601


Sponsors and Collaborators
Federal University of Pelotas
Investigators
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Principal Investigator: Rafael G Lund, PhD Federal University of Pelotas
Publications of Results:

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Responsible Party: Rafael Guerra Lund, Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT02434601    
Other Study ID Numbers: Federal University of Pelotas
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015
Keywords provided by Rafael Guerra Lund, Federal University of Pelotas:
Non-carious cervical lesions
Randomized clinical trial
Permanent dental restoration
Dentin
Adhesion
Restoration
Sensitivity
Prophylaxis
Randomized
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes