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

Minimally Invasive Ridge Augmentation

Sponsors

Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Source 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.

Overall Status Completed
Start Date November 10, 2017
Completion Date November 30, 2019
Primary Completion Date November 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Gain in Alveolar ridge width in millimeters 6 months
Secondary Outcome
Measure Time Frame
Change in Bone density in Hounsefield's units 6 months
Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling one week
Enrollment 20
Condition
Intervention

Intervention type: Device

Intervention name: Low Level Laser Therapy

Description: Hydroxyapatite bone graft with collagen

Other name: G- Bone (Bone Graft)

Eligibility

Criteria:

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

Gender: All

Minimum age: 21 Years

Maximum age: 60 Years

Healthy volunteers: Accepts Healthy Volunteers

Location
facility Krishnadevaraya college of dental sciences
Location Countries

India

Verification Date

December 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Krishnadevaraya College of Dental Sciences & Hospital

Investigator full name: Dr Prabhuji MLV

Investigator title: PROFFESSOR

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Minimally invasive ridge augmentation with LLLT

Arm group type: Experimental

Description: Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) and low-level laser therapy

Arm group label: Minimally invasive ridge augmentation

Arm group type: Active Comparator

Description: Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) alone

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Two groups were made one test and control. The control group were treated with MINIMALLY INVASIVE RIDGE AUGMENTATION technique alone and the test group were treated with adjunctive low-level laser therapy for bone regeneration.

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov