Minimally Invasive Ridge Augmentation
Primary Purpose
Alveolar Bone Loss, Bone Density Increased
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Low Level Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
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
Sites / Locations
- Krishnadevaraya college of dental sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Minimally invasive ridge augmentation with LLLT
Minimally invasive ridge augmentation
Arm Description
Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) and low-level laser therapy
Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) alone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04190576
First Posted
December 5, 2019
Last Updated
December 17, 2019
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04190576
Brief Title
Minimally Invasive Ridge Augmentation
Official Title
Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique With and Without Low Level Laser Therapy: A Comparative Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Bone Density Increased
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minimally invasive ridge augmentation with LLLT
Arm Type
Experimental
Arm Description
Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) and low-level laser therapy
Arm Title
Minimally invasive ridge augmentation
Arm Type
Active Comparator
Arm Description
Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) alone
Intervention Type
Device
Intervention Name(s)
Low Level Laser Therapy
Other Intervention Name(s)
G- Bone (Bone Graft)
Intervention Description
Hydroxyapatite bone graft with collagen
Primary Outcome Measure Information:
Title
Gain in Alveolar ridge width in millimeters
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Bone density in Hounsefield's units
Description
Change in Bone density in Hounsefield units will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months
Time Frame
6 months
Title
Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling
Description
Patient related outcomes during and after the procedure will be recorded
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Minimally Invasive Ridge Augmentation
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