Minimally Invasive Ridge Augmentation

December 17, 2019 updated by: Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bone density in Hounsefield's units
Time Frame: 6 months
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
Time Frame: one week
Patient related outcomes during and after the procedure will be recorded
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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