Minimally Invasive Ridge Augmentation

NCT04190576 | Completed DMC

• 1 other identifier: 02_D012_80831
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss; Bone Density Increased

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Minimally invasive ridge augmentation with LLLT

EXPERIMENTAL

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

Device: Low Level Laser Therapy

Minimally invasive ridge augmentation

ACTIVE COMPARATOR

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

Device: Low Level Laser Therapy

Interventions

Low Level Laser Therapy DEVICE

Hydroxyapatite bone graft with collagen

Also known as: G- Bone (Bone Graft)

Minimally invasive ridge augmentation; Minimally invasive ridge augmentation with LLLT

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Seibert's class 2 defects
• ASA 3 and 4
• Osteoporosis
• uncontrolled diabetes
• immunosuppression
• radiation therapy and bisphosphonate therapy
• Gingival thickness less than 2 mm

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Osteosclerosis

Interventions

Low-Level Light Therapy; Bone Transplantation

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Osteochondrodysplasias; Bone Diseases, Developmental

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: November 10, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)