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

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

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Augmentation
• Intervention / Treatment: Device: Osmed® hydrogel expander implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival recession depth (GRD)	measured at the mid-buccal aspect of the study tooth from the CEJ to the most apical extension of gingival margin (using UNC-15 probe)	6 months
Vestibular depth (VD)	measured from cemento-enamel junction (CEJ) to the deepest part of vestibular mucosa. Measurements were taken with the UNC-15 probe while exerting a firm facial pull on the lip or cheek at a 90° angle to the surface of the teeth.	6 months
Color and texture match to the surrounding tissue	binary ratings of "equal or not equal to surrounding native tissue" assigned upon clinical examination	6 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Study Director: Dr. Prabhuji MLV, MDS, Krishnadevaraya college of dental sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 23, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 02_D012_71909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No