Minimally Invasive Ridge Augmentation

Not Applicable

Completed

• Conditions: Bone Density Increased; Alveolar Bone Loss

• Registration Number: NCT04190576
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-11-10
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gain in Alveolar ridge width in millimeters	6 months	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

Secondary Outcome Measures

Name	Time	Method
Change in Bone density in Hounsefield's units	6 months	Change in Bone density in Hounsefield units will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months
Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling	one week	Patient related outcomes during and after the procedure will be recorded

Trial Locations

Locations (1)

Krishnadevaraya college of dental sciences; 🇮🇳 Bangalore, Karnataka, India