Clinical Trial of the Effect of Different Categories of Adhesive System

Dental Caries Clinical Trial

Official title:

Randomized Clinical Trial of the Effect of Different Categories of Adhesive System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02751970
• Other study ID #: CB027-2014
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 21, 2016
• Last updated: April 25, 2016
• Start date: April 2014
• Est. completion date: April 2018

Study information

• Verified date: April 2016
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Bioética
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive systems by retention rate of resin restorations placed in non carious cervical lesions with four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1 step self-etch adhesive systems.

Description:

The etch-and-rinse (3 and 2 steps) and self-etch (1 and 2 steps) adhesive systems allow the bond between the resins restorations with the dental substrates, but they have mechanism of action different.

The success of resin composite restorations is reliant upon adhesion to the underlying tooth via adhesive systems. The mechanism of adhesion to enamel and dentine could be involved for one hand, the etching the substrates with 30-40% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin 3 steps etch-and- rinse approach or 2 steps when to combine the primer and adhesive into one bottle. For another hand, the self- etch systems with acid monomers in their primer, allow conditioning the surface without phosphoric acid step. So, they consist of either a self-etching primer accompanied by an adhesive resin applied as a subsequent step (2 steps) or a self-etch adhesive, which does not require a separate primer (1 step).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 185
• Est. completion date: April 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Good general health,

• Patients with acceptable oral hygiene level,

• Patients with at least 20 teeth under occlusion.

• Patients with at least four non-carious cervical lesions in four different teeth

• Patients with maximum of eight lesions that needed to be restored.

• These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.

Exclusion Criteria:

• Patients with extremely poor oral hygiene,

• Patients with severe or chronic periodontitis,

• Patients with heavy bruxism habits.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Dental restoration
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
• 3 step ER
Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.
• 2 step ER
Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.
• 2 step SE
Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.
• 1 step SE
Enamel and dentin will be conditioning with acidic primer/adhesive resin.

Locations

Country	Name	City	State
Chile	Universidad Valparaiso	Valparaiso	V region

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Universidade Estadual de Ponta Grossa

Country where clinical trial is conducted

Chile, 

References & Publications (9)

Chee B, Rickman LJ, Satterthwaite JD. Adhesives for the restoration of non-carious cervical lesions: a systematic review. J Dent. 2012 Jun;40(6):443-52. doi: 10.1016/j.jdent.2012.02.007. Epub 2012 Feb 18. Review. — View Citation

Eliguzeloglu Dalkilic E, Omurlu H. Two-year clinical evaluation of three adhesive systems in non-carious cervical lesions. J Appl Oral Sci. 2012 Mar-Apr;20(2):192-9. — View Citation

Heintze SD, Blunck U, Göhring TN, Rousson V. Marginal adaptation in vitro and clinical outcome of Class V restorations. Dent Mater. 2009 May;25(5):605-20. doi: 10.1016/j.dental.2008.11.004. Epub 2009 Jan 14. — View Citation

Kurokawa H, Miyazaki M, Takamizawa T, Rikuta A, Tsubota K, Uekusa S. One-year clinical evaluation of five single-step self-etch adhesive systems in non-carious cervical lesions. Dent Mater J. 2007 Jan;26(1):14-20. — View Citation

Moosavi H, Kimyai S, Forghani M, Khodadadi R. The clinical effectiveness of various adhesive systems: an 18-month evaluation. Oper Dent. 2013 Mar-Apr;38(2):134-41. doi: 10.2341/12-110-CR. Epub 2012 Aug 23. — View Citation

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. Review. — View Citation

Scotti N, Comba A, Gambino A, Manzon E, Breschi L, Paolino D, Pasqualini D, Berutti E. Influence of operator experience on non-carious cervical lesion restorations: Clinical evaluation with different adhesive systems. Am J Dent. 2016 Feb;29(1):33-8. — View Citation

van Dijken JW. Clinical evaluation of three adhesive systems in class V non-carious lesions. Dent Mater. 2000 Jul;16(4):285-91. — View Citation

Van Landuyt KL, Mine A, De Munck J, Jaecques S, Peumans M, Lambrechts P, Van Meerbeek B. Are one-step adhesives easier to use and better performing? Multifactorial assessment of contemporary one-step self-etching adhesives. J Adhes Dent. 2009 Jun;11(3):175-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary caries	Secondary caries near and/or associated of the dental restorations	one year	No
Primary	Retention rate	retention rate of the dental restorations	one year	No
Secondary	Marginal integrity	marginal integrity of the dental restorations	one year	No
Secondary	Marginal discoloration	Marginal discoloration of the dental restorations	one year	No
Secondary	post-operative sensitivity	dentin post-operative sensitivity	one year	No