36-Month Clinical Evaluation of a Universal Adhesive
1 other identifier
interventional
35
1 country
1
Brief Summary
The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2018
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedMay 6, 2019
May 1, 2019
3 years
April 17, 2019
May 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Marginal adaptation
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
From baseline to 36 month
Marginal staining
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction
From baseline to 36 month
Retention
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material
From baseline to 36 month
Postoperative sensitivity
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity
From baseline to 36 month
Seconder caries
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries present. Charlie: Caries present
From baseline to 36 month
Study Arms (3)
Scotchbond universal adhesive (etch-and-rinse)
EXPERIMENTALAcid etch (enamel\&dentin)+adhesive agent Intervention: Device: Adhesive agent
Scotchbond universal adhesive (selective-etch)
EXPERIMENTALAcid etch (only enamel)+adhesive agent Intervention: Device: Adhesive agent
Scotchbond universal adhesive (self-etch)
EXPERIMENTALAdhesive agent Intervention: Device: Adhesive agent
Interventions
Adhesive system
Eligibility Criteria
You may qualify if:
- over 18 years old
- good oral hygiene
- available for recall
- at least 20 teeth under occlusion
- the presence of at least three non-carious cervical lesions
You may not qualify if:
- poor oral hygiene
- bruxism habits
- severe or chronic periodontitis
- If the teeth selected for study, were nonvital, or had any restorations on other surfaces were not included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
Related Publications (3)
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: 26231300BACKGROUNDHanabusa M, Mine A, Kuboki T, Momoi Y, Van Ende A, Van Meerbeek B, De Munck J. Bonding effectiveness of a new 'multi-mode' adhesive to enamel and dentine. J Dent. 2012 Jun;40(6):475-84. doi: 10.1016/j.jdent.2012.02.012. Epub 2012 Feb 28.
PMID: 22381614BACKGROUNDPerdigao J, Kose C, Mena-Serrano AP, De Paula EA, Tay LY, Reis A, Loguercio AD. A new universal simplified adhesive: 18-month clinical evaluation. Oper Dent. 2014 Mar-Apr;39(2):113-27. doi: 10.2341/13-045-C. Epub 2013 Jun 26.
PMID: 23802645BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pricipal Investigator, DDS, PhD
Study Record Dates
First Submitted
April 17, 2019
First Posted
May 1, 2019
Study Start
September 2, 2015
Primary Completion
September 2, 2018
Study Completion
September 2, 2018
Last Updated
May 6, 2019
Record last verified: 2019-05