Minimally Invasive Ridge Augmentation

N/ACompletedNCT04190576

Krishnadevaraya College of Dental Sciences & Hospital20 enrolled

Overview

The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a minimally invasive ridge augmentation technique with and without low level laser therapy. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Twenty 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, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. All the patients were treated with subperiosteal minimally invasive aesthetic ridge augmentation technique. the test group of ten were given low level laser therapy as an adjunct. The clinical and radiographic parameters were recorded at baseline and six months postoperatively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alveolar Bone Loss Bone Density Increased

Interventions

Low Level Laser TherapyDEVICE

Hydroxyapatite bone graft with collagen

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Single or multiple edentulous sites with Seibert's class 1 defects corresponding to colognes 1 and 2 * ASA 1 and 2 * Patients with an esthetic concern * Good oral hygiene Exclusion Criteria: * Seibert's class 2 defects * ASA 3 and 4 * Osteoporosis * uncontrolled diabetes * immunosuppression * radiation therapy and bisphosphonate therapy * Gingival thickness less than 2 mm

Locations (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

Gain in Alveolar ridge width in millimeters

gain in alveolar ridge width at the agumented site in millimeters will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months

Time frame: 6 months

Secondary Outcomes

Change in Bone density in Hounsefield's units

Change in Bone density in Hounsefield units will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months

Time frame: 6 months

Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling

Patient related outcomes during and after the procedure will be recorded

Time frame: one week

Data from ClinicalTrials.gov

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