Clinical trial NCT03753906: Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
Official title: Clinical and Optical Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Augmentation
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Keratinized tissue width (KTW)
timeFrame: 6 months
measure: Keratinized tissue thickness (KTT)
timeFrame: 6 months
measure: Optical scanning for analysis of tissue thickness
timeFrame: 6 months
Secondary outcomes:
measure: Gingival recession depth (GRD)
timeFrame: 6 months
measure: Vestibular depth (VD)
timeFrame: 6 months
measure: Color and texture match to the surrounding tissue
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Krishnadevaraya College of Dental Sciences
name: Dr. Prabhuji MLV, MDS
role: STUDY_DIRECTOR
References: