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Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults

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ClinicalTrials.gov Identifier: NCT00658138
Recruitment Status : Completed
First Posted : April 14, 2008
Results First Posted : March 26, 2012
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
3M

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dental Caries
Interventions Device: 3M ESPE Adper Scotchbond SE
Device: 3M ESPE Adper Scotchbond 1XT
Enrollment 61
Recruitment Details 61 subjects were recruited from 70 patients with a total of 134 study teeth. Recruitment was from December 2008 to April 2009. Subjects were recruited from patients attending PI's clinic
Pre-assignment Details All enrolled participants took part in the study
Arm/Group Title 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT
Hide Arm/Group Description 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
Period Title: Overall Study
Started 61
Completed 40
Not Completed 21
Arm/Group Title 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT
Hide Arm/Group Description 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
<=18 years
0
   0.0%
Between 18 and 65 years
61
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
34
  55.7%
Male
27
  44.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 61 participants
61
1.Primary Outcome
Title Percentage of Restorations Scoring Alpha
Hide Description Restorations were scored Alpha, Bravo or Charlie for retention, post-operative sensitivity, anatomic form, margin integrity, color match, stain resistance, and secondary caries. Alpha score = 'excellent' Bravo = 'acceptable' Charlie = 'unsatisfactory'. Total Alpha scores were evaluated for the primary outcome.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the number of study teeth available for review at 12 months
Arm/Group Title Scotchbond SE Scotchbond 1XT
Hide Arm/Group Description:
3M ESPE Adper Scotchbond SE
3M ESPE Adper Scotchbond 1XT
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
46 46
Measure Type: Number
Unit of Measure: percentage of Alpha scores
100 96
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Scotchbond SE, Scotchbond 1XT
Comments Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.
Type of Statistical Test Non-Inferiority or Equivalence
Comments No power calculation done - pilot study
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Scotchbond SE, Scotchbond 1XT
Comments Null hypothesis is adhesives are not different in clinical performance at one year
Type of Statistical Test Non-Inferiority or Equivalence
Comments No power calculation done - pilot study
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame One year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT
Hide Arm/Group Description 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
All-Cause Mortality
3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT
Affected / at Risk (%)
Total   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT
Affected / at Risk (%)
Total   0/61 (0.00%) 
Main limitation of study was small sample size and short duratrion. Study was a pilot of one year's duration.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Giovanni Dondi dall'Orologio
Organization: University of Bologna, Italy
Phone: +39 051-2088132
EMail: gdondi@alma.unibo.it
Layout table for additonal information
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00658138     History of Changes
Other Study ID Numbers: CR-07-020
First Submitted: April 8, 2008
First Posted: April 14, 2008
Results First Submitted: December 29, 2011
Results First Posted: March 26, 2012
Last Update Posted: March 26, 2012