Trial Outcomes & Findings for Comparative Study of Implant Surfaces to Enhance Stabilization in Patients With Type 2 Diabetes (NCT NCT01142297)

NCT ID: NCT01142297

Last Updated: 2018-01-03

Results Overview

resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2018-01-03

Participant Flow

Participant milestones

Measure	Dental Implant standard SLA surface and chemically-modified surface implant
Overall Study STARTED	24
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study of Implant Surfaces to Enhance Stabilization in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Dental Implant n=24 Participants standard SLA surface and chemically modified surface dental implant : standard SLA surface and modified dental implant : chemically modified surface
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.

Outcome measures

Measure	SLA Minimum ISQ HbA1c<9.5 n=24 Participants standard SLA surface dental implant : standard SLA surface	Modified SLA Minimum ISQ HbA1c<9.5 n=24 Participants chemically modified surface modified dental implant : chemically modified surface
Implant Stability Quotient (ISQ)	61.9 units on a scale Standard Error 5.6	61.3 units on a scale Standard Error 3.2

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Dental Implant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modified Dental Implant

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

Thomas W. Oates

University of Texas Health Science Center at San Antonio

Phone: 210-567-3590

Email: oates@uthscsa.edu

Results disclosure agreements

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