Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03753906
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2018-11-21
Brief Title:
Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
Sponsor:
Krishnadevaraya College of Dental Sciences Hospital
Organization:
Krishnadevaraya College of Dental Sciences Hospital
Study Overview
Official Title:
Clinical and Optical Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is a human prospective single centre single blind randomised controlled clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel expander Osmed to gain keratinised tissue around the dentulous area The trial is in accordance to the Consolidated Standards of Reporting Trials CONSORT criteria 2010
Detailed Description:
Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study A detailed thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination All patients were informed about the nature of the study surgical procedure involved potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients
All the patients were implanted with self-inflating hydrogel expander Osmed in subperiosteal positions using the pouch technique in the mandibular anterior region The clinical parameters were recorded at baseline two weeks post expander retrieval three months and six months post-operatively
All the patients were implanted with self-inflating hydrogel expander Osmed in subperiosteal positions using the pouch technique in the mandibular anterior region The clinical parameters were recorded at baseline two weeks post expander retrieval three months and six months post-operatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None