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

Krishnadevaraya College of Dental Sciences & Hospital

Status: Completed

Conditions: Soft Tissue Augmentation

Treatments: Device: Osmed® hydrogel expander implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03753906

02_D012_71909

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Osmed® hydrogel expander implantation

Experimental group

Description:

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

Treatment:

Device: Osmed® hydrogel expander implantation