Dentin Treatments for Restorations of Cervical Lesions Non-Carious

NCT02434601 | Unknown Phase 2 DMC

• 1 other identifier: Federal University of Pelotas
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adhesion

Keywords

Non-carious cervical lesions; Randomized clinical trial; Permanent dental restoration; Dentin; Adhesion; Restoration; Sensitivity; Prophylaxis; Randomized

Outcome Measures

Primary Outcomes (1)

• Number of teeth with lost restorations

  From Baseline restorations at 3 years

Secondary Outcomes (2)

• Presence or not of marginal leakage

  From Baseline restorations at 3 years

• Presence or not of dentin hypersensitivity

  From Baseline restorations at 3 years

Study Arms (3)

Treatment of Dentin Surface

OTHER

Treatment of Dentin Surface: Restoration made following the protocol recommended by the manufacturer of the materials.

Procedure: Treatment of Dentin Surface

Dentin Surface

EXPERIMENTAL

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

Procedure: Dentin Surface

Treatment

EXPERIMENTAL

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

Interventions

Treatment of Dentin Surface PROCEDURE

* 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.

Also known as: Preconditioning of Dental Surface

Treatment of Dentin Surface

Dentin Surface PROCEDURE

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

Dentin Surface

Treatment PROCEDURE

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.

Treatment

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Related Publications (17)

• Demarco FF, Baldissera RA, Madruga FC, Simoes RC, Lund RG, Correa MB, Cenci MS. Anterior composite restorations in clinical practice: findings from a survey with general dental practitioners. J Appl Oral Sci. 2013 Nov-Dec;21(6):497-504. doi: 10.1590/1679-775720130013.

  PMID: 24473714 RESULT

• Akimoto N, Takamizu M, Momoi Y. 10-year clinical evaluation of a self-etching adhesive system. Oper Dent. 2007 Jan-Feb;32(1):3-10. doi: 10.2341/06-46.

  PMID: 17288322 RESULT

• Bartlett D, Ganss C, Lussi A. Basic Erosive Wear Examination (BEWE): a new scoring system for scientific and clinical needs. Clin Oral Investig. 2008 Mar;12 Suppl 1(Suppl 1):S65-8. doi: 10.1007/s00784-007-0181-5. Epub 2008 Jan 29.

  PMID: 18228057 RESULT

• Bartlett DW, Lussi A, West NX, Bouchard P, Sanz M, Bourgeois D. Prevalence of tooth wear on buccal and lingual surfaces and possible risk factors in young European adults. J Dent. 2013 Nov;41(11):1007-13. doi: 10.1016/j.jdent.2013.08.018. Epub 2013 Sep 1.

  PMID: 24004965 RESULT

• Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.

  PMID: 17262225 RESULT

• Karakaya S, Unlu N, Say EC, Ozer F, Soyman M, Tagami J. Bond strengths of three different dentin adhesive systems to sclerotic dentin. Dent Mater J. 2008 May;27(3):471-9. doi: 10.4012/dmj.27.471.

  PMID: 18717178 RESULT

• Kim SY, Lee KW, Seong SR, Lee MA, Lee IB, Son HH, Kim HY, Oh MH, Cho BH. Two-year clinical effectiveness of adhesives and retention form on resin composite restorations of non-carious cervical lesions. Oper Dent. 2009 Sep-Oct;34(5):507-15. doi: 10.2341/08-006C.

  PMID: 19830963 RESULT

• Lopes GC, Baratieri CM, Baratieri LN, Monteiro S Jr, Cardoso Vieira LC. Bonding to cervical sclerotic dentin: effect of acid etching time. J Adhes Dent. 2004 Spring;6(1):19-23.

  PMID: 15119583 RESULT

• Lopes GC, Vieira LC, Monteiro S Jr, Caldeira de Andrada MA, Baratieri CM. Dentin bonding: effect of degree of mineralization and acid etching time. Oper Dent. 2003 Jul-Aug;28(4):429-39.

  PMID: 12877429 RESULT

• Moretto SG, Russo EM, Carvalho RC, De Munck J, Van Landuyt K, Peumans M, Van Meerbeek B, Cardoso MV. 3-year clinical effectiveness of one-step adhesives in non-carious cervical lesions. J Dent. 2013 Aug;41(8):675-82. doi: 10.1016/j.jdent.2013.05.016. Epub 2013 Jun 6.

  PMID: 23747824 RESULT

• Perdigao J. Dentin bonding-variables related to the clinical situation and the substrate treatment. Dent Mater. 2010 Feb;26(2):e24-37. doi: 10.1016/j.dental.2009.11.149. Epub 2009 Dec 14.

  PMID: 20005565 RESULT

• Peumans M, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Clinical effectiveness of contemporary adhesives: a systematic review of current clinical trials. Dent Mater. 2005 Sep;21(9):864-81. doi: 10.1016/j.dental.2005.02.003.

  PMID: 16009415 RESULT

• Ritter AV, Heymann HO, Swift EJ Jr, Sturdevant JR, Wilder AD Jr. Clinical evaluation of an all-in-one adhesive in non-carious cervical lesions with different degrees of dentin sclerosis. Oper Dent. 2008 Jul-Aug;33(4):370-8. doi: 10.2341/07-128.

  PMID: 18666493 RESULT

• Da Rosa Rodolpho PA, Donassollo TA, Cenci MS, Loguercio AD, Moraes RR, Bronkhorst EM, Opdam NJ, Demarco FF. 22-Year clinical evaluation of the performance of two posterior composites with different filler characteristics. Dent Mater. 2011 Oct;27(10):955-63. doi: 10.1016/j.dental.2011.06.001. Epub 2011 Jul 16.

  PMID: 21762980 RESULT

• Salz U, Bock T. Testing adhesion of direct restoratives to dental hard tissue - a review. J Adhes Dent. 2010 Oct;12(5):343-71. doi: 10.3290/j.jad.a19741.

  PMID: 20978636 RESULT

• Tay FR, Pashley DH. Resin bonding to cervical sclerotic dentin: a review. J Dent. 2004 Mar;32(3):173-96. doi: 10.1016/j.jdent.2003.10.009.

  PMID: 15001284 RESULT

• Wilder AD Jr, Swift EJ Jr, Heymann HO, Ritter AV, Sturdevant JR, Bayne SC. A 12-year clinical evaluation of a three-step dentin adhesive in noncarious cervical lesions. J Am Dent Assoc. 2009 May;140(5):526-35. doi: 10.14219/jada.archive.2009.0220.

  PMID: 19411519 RESULT

MeSH Terms

Conditions

Tissue Adhesions; Hypersensitivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Rafael G Lund, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: May 5, 2015
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2016
• Last Updated: May 5, 2015

Record last verified: 2015-04