Trial Outcomes & Findings for Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements (NCT NCT00591942)

NCT ID: NCT00591942

Last Updated: 2018-03-08

Results Overview

Scores reported are subjects reporting any pain (yes/no)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations
• Results posted on: 2018-03-08

Participant Flow

Subjects needing a dental crown or dental bridge

Unit of analysis: Crowns

Participant milestones

Measure	VivaGlass Cement Cross over design, two crowns per subject, one crown cemented with VivaGlass/subject	Multilink Cement Cross over design, two crowns per subject, one crown cemented with Multilink/subject
Overall Study STARTED	36 36	36 36
Overall Study COMPLETED	36 36	36 36
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements

Baseline characteristics by cohort

Measure	Group 1 n=36 Participants Note only one group is listed since EACH subject received TWO crowns. AS cross-over design, ONE crown had the VivaGlass cement and the second crown (in the same subject) had the Multi-link cement.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations

Scores reported are subjects reporting any pain (yes/no)

Outcome measures

Measure	Ivoclar Vivaglass CEM IC Cement n=36 crowns Ivoclar Vivaglass CEM IC cement for ceramic crowns and 3-unit dental bridge	Ivoclar/Vivadent Composite Resin Cement n=36 crowns Ivoclar/Vivadent Composite Resin Cement for ceramic crowns and 3-unit dental bridge
Incidence of Post-operative Pain (Yes/no) 0 Hour	1 participants	0 participants
Incidence of Post-operative Pain (Yes/no) 24 hours	1 participants	2 participants
Incidence of Post-operative Pain (Yes/no) 7 days	3 participants	5 participants
Incidence of Post-operative Pain (Yes/no) 6 month	4 participants	3 participants
Incidence of Post-operative Pain (Yes/no) 12 months	2 participants	3 participants
Incidence of Post-operative Pain (Yes/no) 18 months	3 participants	3 participants
Incidence of Post-operative Pain (Yes/no) 24 months	3 participants	3 participants

Adverse Events

Ivoclar Vivaglass CEM IC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ivoclar/Vivadent Composite Resin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ivoclar Vivaglass CEM IC n=36 participants at risk Ivoclar Vivaglass CEM IC cement for ceramic crowns and 3-unit dental bridge	Ivoclar/Vivadent Composite Resin n=36 participants at risk Ivoclar/Vivadent Composite Resin Cement for ceramic crowns and 3-unit dental bridge
General disorders Crown Fracture	2.8% 1/36 • Number of events 1 • 0 to 24 months side effects of the dental procedures from transient pain to intervention. All patient and clinician reported side effects was recorded.	0.00% 0/36 • 0 to 24 months side effects of the dental procedures from transient pain to intervention. All patient and clinician reported side effects was recorded.

Additional Information

Dr. Clark Stanford

University of Iowa

Phone: 319-335-7381

Email: Clark-Stanford@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place