Trial Outcomes & Findings for Treatment of Post-Extraction Dehisced Socket - A Case Series Study (NCT NCT02980211)

Last Updated: 2020-02-05

Results Overview

Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Baseline and 20 weeks post-extraction

Results posted on

2020-02-05

Participant milestones
Measure	Tooth Extraction and Graft Dehisced Socket Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Treatment of Post-Extraction Dehisced Socket - A Case Series Study

Baseline characteristics by cohort
Measure	Tooth Extraction and Graft Dehisced Socket n=17 Participants Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	51.82 years STANDARD_DEVIATION 13.61 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

Timeframe: Baseline and 20 weeks post-extraction

Population: Two of the 17 DICOM datasets could not be analyzed due to extensive scattering, therefore the final sample size for this outcome was 15

Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans

Outcome measures
Measure	Tooth Extraction and Graft Dehisced Socket n=15 Participants Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane
Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction	73.26 mm3 Standard Deviation 77.27

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Tooth Extraction and Graft Dehisced Socket n=17 participants at risk Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane
Surgical and medical procedures Premature barrier membrane exfoliation	5.9% 1/17 • Number of events 1 • 24 weeks post-extraction

University of Iowa College of Dentistry

Phone: 3193357241