Minimally Invasive Ridge Augmentation

Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique With and Without Low Level Laser Therapy: A Comparative Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss; Bone Density Increased
• Intervention / Treatment: Device: Low Level Laser Therapy

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Krishnadevaraya college of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Minimally invasive ridge augmentation with LLLT; Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) and low-level laser therapy	Device: Low Level Laser Therapy; Hydroxyapatite bone graft with collagen; Other Names: G- Bone (Bone Graft)
ACTIVE_COMPARATOR: Minimally invasive ridge augmentation; Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) alone	Device: Low Level Laser Therapy; Hydroxyapatite bone graft with collagen; Other Names: G- Bone (Bone Graft)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	one week

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2017
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (ACTUAL): December 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Diseases, Developmental; Osteochondrodysplasias; Bone Resorption; Alveolar Bone Loss; Osteosclerosis
• Other Study ID Numbers: 02_D012_80831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No