Trial Outcomes & Findings for Longitudinal Study of Dental Implant Therapy in HIV Positive Patients (NCT NCT01211288)

Last Updated: 2020-06-02

Results Overview

Dental implant supported restorations functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

Baseline to 12 months after implant restoration complete

Results posted on

2020-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	HIV Negative Group This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Overall Study STARTED	21	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	HIV Negative Group This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV Negative Group n=21 Participants This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group n=20 Participants This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants	20 Participants n=4 Participants	37 Participants n=27 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	5 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	15 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants	0 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	11 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	9 Participants n=4 Participants	21 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	21 participants n=93 Participants	20 participants n=4 Participants	41 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months after implant restoration complete

Population: Unable to do follow up on 3 participants - two participants from HIV negative group and one participant from HIV positive group, and one implant failure from HIV positive group

Dental implant supported restorations functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.

Outcome measures

Outcome measures
Measure	HIV Negative Group n=28 implants This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group n=26 implants This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects	28 implants	25 implants

PRIMARY outcome

Timeframe: Baseline to 24 months after implant restoration complete

Population: Unable to do follow up on 7 participants, three participants from HIV negative group and four participants from HIV positive group

Dental Implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.

Outcome measures

Outcome measures
Measure	HIV Negative Group n=27 implants This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group n=20 implants This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects	27 implants	20 implants

PRIMARY outcome

Timeframe: Baseline to 36 months after implant restoration complete

Population: Unable to do follow up on 11 participants, five participants from HIV negative group and six participants from HIV positive group

Dental implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.

Outcome measures

Outcome measures
Measure	HIV Negative Group n=25 implants This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group n=17 implants This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects	25 implants	17 implants

SECONDARY outcome

Timeframe: 12 months after implant restoration

Population: Unable to do follow up on three participants, two from HIV negative group and one from HIV positive group

Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs.

Outcome measures

Outcome measures
Measure	HIV Negative Group n=28 implants This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group n=25 implants This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects	0.34 millmeters Standard Deviation 0.58	0.35 millmeters Standard Deviation 0.71

SECONDARY outcome

Timeframe: 24 months after implant restoration

Population: Unable to do follow up on 7 participants, three from HIV negative group and four from HIV positive group

Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs.

Outcome measures

Outcome measures
Measure	HIV Negative Group n=27 implants This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group n=20 implants This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects	0.39 millmeters Standard Deviation 0.49	0.33 millmeters Standard Deviation 0.61

SECONDARY outcome

Timeframe: 36 months after implant restoration

Population: Unable to do follow up on 11 participants, five from HIV negative group and six from HIV positive group

Radiographic examination of implant osseointegration and bone loss by using traditional periapical and /or bitewing radiographs.

Outcome measures

Outcome measures
Measure	HIV Negative Group n=25 implants This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System	HIV Positive Group n=17 implants This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects	0.44 millmeters Standard Deviation 0.52	0.48 millmeters Standard Deviation 0.95

Adverse Events

HIV Negative Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV Positive Group

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

Dr. Toni Tien Neumeier

University of Alabama at Birmingham

Phone: 205-934-5459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place