Trial Outcomes & Findings for Implant Placement With Simultaneous Gum Grafting (NCT NCT01431144)

NCT ID: NCT01431144

Last Updated: 2017-02-01

Results Overview

Soft tissue thickness at the facial osseous crest.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-02-01

Participant Flow

27 patients were entered, 13 for the test allograft group and 14 for the positive control connective tissue autograft group

There were no exclusions prior to assignment or treatment.

Participant milestones

Measure	Connective Tissue Allograft A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.	Connective Tissue Autograft A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
Overall Study STARTED	13	14
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Connective Tissue Allograft A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.	Connective Tissue Autograft A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
Overall Study Implant mobility and removal	2	0

Baseline Characteristics

Implant Placement With Simultaneous Gum Grafting

Baseline characteristics by cohort

Measure	Connective Tissue Allograft n=13 Participants A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.	Connective Tissue Autograft n=14 Participants A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 21 • n=5 Participants	57 years STANDARD_DEVIATION 10 • n=7 Participants	52 years STANDARD_DEVIATION 16 • n=5 Participants
Gender Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Soft tissue thickness at the facial osseous crest.

Outcome measures

Measure	Connective Tissue Allograft n=11 Participants A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.	Connective Tissue Autograft n=14 Participants A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
Soft Tissue Thickness Over the Implant	0.6 mm Standard Deviation 1.2	0.4 mm Standard Deviation 0.7

Adverse Events

Connective Tissue Allograft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Connective Tissue Autograft

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

Henry Greenwell, Principal Investigator

University of Louisville

Phone: 502-852-6928

Email: henry.greenwell@louisville.edu

Results disclosure agreements

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