Trial Outcomes & Findings for Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults (NCT NCT00658138)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

12 months

Results posted on

2024-10-02

Participant Flow

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

All enrolled participants took part in the study

Participant milestones

Participant milestones
Measure	3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
Overall Study STARTED	61
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT n=61 Participants 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment Italy	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Analysis was based on the number of study teeth available for review at 12 months

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.

Outcome measures

Outcome measures
Measure	Scotchbond SE n=46 restorations 3M ESPE Adper Scotchbond SE	Scotchbond 1XT n=46 restorations 3M ESPE Adper Scotchbond 1XT
Percentage of Restorations Scoring Alpha	100 percentage of Alpha scores	96 percentage of Alpha scores

Adverse Events

3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Giovanni Dondi dall'Orologio

University of Bologna, Italy

Phone: +39 051-2088132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place