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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive ridge augmentation with LLLT | Experimental | Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) and low-level laser therapy |
|
| Minimally invasive ridge augmentation | Active Comparator | Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Laser Therapy | Device | Hydroxyapatite bone graft with collagen |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krishnadevaraya college of dental sciences | Bangalore | Karnataka | 562157 | India |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D010026 | Osteosclerosis |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D016378 | Tissue Transplantation |
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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.
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|
Patient related outcomes during and after the procedure will be recorded |
| one week |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D064987 |
| Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |