NCT01369134

Brief Summary

Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

June 7, 2011

Last Update Submit

September 30, 2024

Conditions

Keywords

self-etch adhesiveselective enamel etchingAdper Easy BondSupreme UltraMolar and premolar teethAdultClass I and II cavities

Outcome Measures

Primary Outcomes (1)

  • Retention of the Restoration

    Bonded filling still in place

    one year

Secondary Outcomes (1)

  • Clinical performance of the study restoration

    one year

Interventions

Bonding composite to restore Class I or Class II cavities

Also known as: self etch adhesive with enamel etch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dental patients

You may qualify if:

  • years or older
  • written informed consent
  • regular dental attender, can return to clinic for study recalls
  • good medical health
  • normal saliva flow
  • has one or two pairs of back teeth that require a Class I or II restoration of appropriate size
  • study teeth that are vital

You may not qualify if:

  • currently in an evaluation of other dental materials
  • an irregular dental attender
  • has unacceptable oral hygiene standards
  • has chronic periodontitis or rampant caries
  • has teeth with signs of periapical pathology
  • has history of pulp problems, and/or needs pulp treatment
  • women who are pregnant or breast-feeding
  • has known allergy to resin composite or latex
  • has serious chronic disease requiring hospitalization
  • has oral soft tissue pathologies
  • takes medications which, in the opinion of the investigator, could interfere with the conduct of the study
  • has current or recent history of alcohol or other substance abuse
  • is an employee of the sponsor or the study site, or members of their immediate family
  • has had any restorative treatment of teeth involved in the study in the last twelve months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Carlos Munoz, DDS

    Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 8, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations