Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 5, 2016

Primary Completion Date

July 31, 2018

Study Completion Date

January 31, 2019

Conditions
Soft Tissue Augmentation
Interventions
DEVICE

Osmed® hydrogel expander implantation

Under local anaesthesia, a small vertical incision, adapted to the diameter of the Osmed® sself-inflating hydrogel expander, was made with #15 scalpel blade at the mesial line angle of the adjacent tooth which started below the gingival margin extending from the keratinized tissue above the MGJ to the non-keratinized tissue beyond the MGJ. A minimally invasive preparation of a subperiosteal pouch was performed with KPA tunnelling knife. Size of the pouch was controlled with the specific surgical template to ensure the device easily fits into the prepared pouch without tension. Expanders were secured in the correct position with a bone fixation screw, at the flat end, which does not possess an expansion capability. The wound was closed with 3-0 silk suture using simple interrupted sutures.

All Listed Sponsors
lead

Krishnadevaraya College of Dental Sciences & Hospital

OTHER

NCT03753906 - Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region | Biotech Hunter | Biotech Hunter