Clinical Evaluation of Different Universal Adhesive Systems in Non-carious Cervical Lesions.

NCT04707898 | Unknown

• 1 other identifier: 2019/37-Rev/2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the performance of universal adhesives containing different-solvent-based in the restoration of non-carious cervical lesions (NCCLs).

Conditions

Non-carious Cervical Lesions

Keywords

universal adhesive, non-carious lesions, randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• FDI World Dental Federation criteria

  Retention and marginal adaptation

  24-months

Study Arms (2)

Group Single Bond Universal

EXPERIMENTAL

Single Bond Universal adhesive system with selective-etch approach following the manufacturer's instruction

Device: Single Bond Universal

Group G-Premio Bond

EXPERIMENTAL

G-Premio Bond Adhesive System with selective-etch approach following the manufacturer's instruction

Device: G-Premio Bond

Interventions

Single Bond Universal DEVICE

Adhesive system

Group Single Bond Universal

G-Premio Bond DEVICE

Adhesive system

Group G-Premio Bond

Eligibility Criteria

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

You may qualify if:

• Participant age should be 18-65 years.
• Good general health condition
• Good oral hygiene
• Should have at least 4 noncarious cervical lesion
• Must not have rampant caries
• At least 20 teeth in occlusion

You may not qualify if:

• Serious medical problems, allergies to product ingredients
• Poor oral hygiene
• Severe periodontal problems
• Caries or restorative treatment on teeth included in the study
• Parafunctional behavior
• Abutment of tested teeth to a removable prosthesis.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Istanbul Okan University Faculty of Dentistry

Istanbul, Tuzla, 34959, Turkey (Türkiye)

Location

Related Publications (7)

• Van Landuyt KL, Peumans M, Fieuws S, De Munck J, Cardoso MV, Ermis RB, Lambrechts P, Van Meerbeek B. A randomized controlled clinical trial of a HEMA-free all-in-one adhesive in non-carious cervical lesions at 1 year. J Dent. 2008 Oct;36(10):847-55. doi: 10.1016/j.jdent.2008.06.005. Epub 2008 Jul 25.

  PMID: 18656295 BACKGROUND

• Ermis RB, Van Landuyt KL, Cardoso MV, De Munck J, Van Meerbeek B, Peumans M. Clinical effectiveness of a one-step self-etch adhesive in non-carious cervical lesions at 2 years. Clin Oral Investig. 2012 Jun;16(3):889-97. doi: 10.1007/s00784-011-0565-4. Epub 2011 May 21.

  PMID: 21603966 BACKGROUND

• 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 BACKGROUND

• Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.

  PMID: 26231300 BACKGROUND

• Hafer M, Jentsch H, Haak R, Schneider H. A three-year clinical evaluation of a one-step self-etch and a two-step etch-and-rinse adhesive in non-carious cervical lesions. J Dent. 2015 Mar;43(3):350-61. doi: 10.1016/j.jdent.2014.12.009. Epub 2014 Dec 23.

  PMID: 25541248 BACKGROUND

• Szesz A, Parreiras S, Reis A, Loguercio A. Selective enamel etching in cervical lesions for self-etch adhesives: A systematic review and meta-analysis. J Dent. 2016 Oct;53:1-11. doi: 10.1016/j.jdent.2016.05.009. Epub 2016 Jul 2.

  PMID: 27381814 BACKGROUND

• Yurdaguven GY, Dogruer I, Cam M, Ulukapi H, Aykor AA. Clinical evaluation of different solvent type and HEMA-content of universal adhesive systems in non-carious cervical lesions: a two-year double-blind split-mouth randomized clinical trial. BMC Oral Health. 2025 Oct 22;25(1):1661. doi: 10.1186/s12903-025-07081-0.

  PMID: 41126209 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof.

Model Details: A randomized controlled clinical trial

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 13, 2021
• Study Start: October 15, 2020
• Primary Completion: October 15, 2022
• Study Completion: November 15, 2022
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)