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

• ClinicalTrials.gov Identifier: NCT03753906
• Recruitment Status: Completed
• First Posted: November 27, 2018
• Last Update Posted: March 1, 2019
• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Information provided by (Responsible Party): Krishnadevaraya College of Dental Sciences & Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Soft Tissue Augmentation	Device: Osmed® hydrogel expander implantation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All the patients were implanted with self-inflating hydrogel expander in subperiosteal positions using the pouch technique in the mandibular anterior region.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Optical Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
• Actual Study Start Date: November 5, 2016
• Actual Primary Completion Date: July 2018
• Actual Study Completion Date: January 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Keratinized tissue width (KTW) [ Time Frame: 6 months ]
   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).
2. Keratinized tissue thickness (KTT) [ Time Frame: 6 months ]
   measured at the mid-buccal aspect of the study tooth just below the marginal gingiva using an endodontic file.
3. Optical scanning for analysis of tissue thickness [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. Gingival recession depth (GRD) [ Time Frame: 6 months ]
   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)
2. Vestibular depth (VD) [ Time Frame: 6 months ]
   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.
3. Color and texture match to the surrounding tissue [ Time Frame: 6 months ]
   binary ratings of "equal or not equal to surrounding native tissue" assigned upon clinical examination

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Krishnadevaraya College of Dental Sciences & Hospital

Investigators

• Study Director: Dr. Prabhuji MLV, MDS; Krishnadevaraya College of Dental Sciences

More Information

• Responsible Party: Krishnadevaraya College of Dental Sciences & Hospital
• ClinicalTrials.gov Identifier: NCT03753906
• Other Study ID Numbers: 02_D012_71909
• First Posted: November 27, 2018
• Last Update Posted: March 1, 2019
• Last Verified: February 2019

• 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