CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
PTFE application +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05982353
NCT05982353Phase 1Completed

Effect of Using a Hemostatic Gelatin Sponge Versus a Dense Polytetrafluorethylene Membrane for Socket Sealing Following Immediate Implant Placement. A Randomized Clinical Trial

Cairo University·interventional·Posted Aug 8, 2023·Updated Feb 7, 2024

In Brief

A Phase 1 clinical trial evaluating PTFE application and Gelatin sponge for Dental Implant Failed and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Digital panoramas will be made to assess the implant sites. The included patients are assigned to their respective groups randomly. After implant submerging in the study group 2 layers of hemostatic resorbable gelatin sponge is fixed in the implant site; while with the control group PTFE is fixed. After 3 weeks the PTFE was removed while the gelatin sponge should be resorbed. 3 months later the implants are to be assessed for stability and a reverse torque test was used to confirm osseointegration during uncovering. Follow-up appointments at 1,3 weeks and 1,2 \& 3 months were planned.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedAug 8, 2023
Enrollment StartJun 1, 2022
Primary CompletionJun 1, 2023
Study CompletionOct 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 2.9 years ago

Interventions

PTFE applicationdevice

Polytetrafluoroethylene membrane used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup

Gelatin spongedevice

gelatin sponge used over immediate implants intraoperatively. Healing and osseointegration with the exposed membrane is assessed at the end of followup