Minimally Invasive Ridge Augmentation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alveolar Bone Loss, Bone Density Increased

Intervention / Treatment
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* Device: Low Level Laser Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive ridge augmentation with LLLT<br>Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) and low-level laser therapy | Device: Low Level Laser Therapy<br>* Hydroxyapatite bone graft with collagen<br>* Other names: G- Bone (Bone Graft);|
| Active Comparator: Minimally invasive ridge augmentation<br>Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) alone | Device: Low Level Laser Therapy<br>* Hydroxyapatite bone graft with collagen<br>* Other names: G- Bone (Bone Graft);|

What is the study measuring?
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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 |