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

NCT03753906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-03-01

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Krishnadevaraya College of Dental Sciences & Hospital

    lead OTHER

Principal Investigators

  • Dr. Prabhuji MLV, MDS · Krishnadevaraya College of Dental Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-05
Primary Completion
2018-07-31
Completion
2019-01-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753906 on ClinicalTrials.gov