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

NCT03753906 | Completed FDA Device

• 1 other identifier: 02_D012_71909
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Soft Tissue Augmentation

Outcome Measures

Primary Outcomes (3)

• Keratinized tissue width (KTW)

  measured from the most apical gingival margin to the mucogingival junction (MGJ), with the MGJ location determined using the visual method (Schiller's potassium iodide solution).

  6 months

• Keratinized tissue thickness (KTT)

  measured at the mid-buccal aspect of the study tooth just below the marginal gingiva using an endodontic file.

  6 months

• Optical scanning for analysis of tissue thickness

  alginate impressions were made at the baseline prior to expander placement, immediately after the removal of expander and 6 months post-augmentation. The prepared casts were assessed for soft tissue changes by optical scan using 3D camera (Intellidenta AG, Basel, Switzerland). The obtained digital images of the casts reflecting the different treatment time were then superimposed and matched in one common coordinate system. The buccal surfaces of the study teeth were used as a reference point for the superimposition of different images. Subsequently, a defined area of interest at each site were measured and the difference in the linear distance between the time points were calculated.

  6 months

Secondary Outcomes (3)

• Gingival recession depth (GRD)

  6 months

• Vestibular depth (VD)

  6 months

• Color and texture match to the surrounding tissue

  6 months

Study Arms (1)

Osmed® hydrogel expander implantation

EXPERIMENTAL

Implantation of Osmed® hydrogel expander was done in subperiosteal positions using the pouch technique in the mandibular anterior region.

Device: Osmed® hydrogel expander implantation

Interventions

Osmed® hydrogel expander implantation DEVICE

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.

Osmed® hydrogel expander implantation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients willing to participate in the study
• Patients above 18 years of age
• Systemically healthy patients
• Patients exhibiting keratinized tissue width \< 2 mm
• Patients manifesting Miller's Class I or Class II recession
• Patients who demonstrate good plaque control ( PI \< 10% ) and showing good compliance
• Uncompromised adjacent teeth with healthy gingival conditions

You may not qualify if:

• Untreated periodontal disease, caries
• Insufficient oral hygiene
• Thin biotype ( \< 0.8 mm )
• Use of tobacco
• Previous radiation therapy
• Patients with known systemic diseases and conditions as uncontrolled diabetes mellitus or haemorrhagic disorders
• Pregnant and lactating women
• Non-compliant patients

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Officials

• Dr. Prabhuji MLV, MDS

  Krishnadevaraya College of Dental Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All the patients were implanted with self-inflating hydrogel expander in subperiosteal positions using the pouch technique in the mandibular anterior region.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: November 5, 2016
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02