Mini Distractor in Vertically Deficient Bone

Study Overview
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Brief Summary
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ADO is a bone regeneration technique, introduced by Chin and Toth in 1996 based in a biological process used for regenerate and consolidate bone between two bone segments obtained after osteotomy.These segments have been gradually separated by the process of distraction. ADO can be performed both horizontally (AHDO) and vertically (AVDO).

Detailed Description
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Distraction osteogenesis (DO) can be used to regenerate missing hard and soft tissue, Distraction osteogenesis relies on the body's ability to generate bone as two segments of bone are distracted apart. The osteotomies are created and the distraction device is placed. Typically, there is a latency phase of one week were a ﬁbrovascular bridge is formed in the osteotomy site. This provides a template to generate new bone as the segments are distracted apart during the activation phase. Once the desired distraction has occurred, the device is left in place for a period of time. Once consolidation (typically 2 to 6 months) has occurred, the distraction device can be removed and implants can be placed. Chiapasco compared GBR to DO and found that both are equally effective in alveolar bone augmentation for implant placement and further stated that the long-term prognosis of vertical bone gain in DO is more predictable.

Official Title
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Efficacy of Distraction Osteogenesis in Vertically Deficient Anterior Maxillary and Mandibular Bone by Using Mini Distractor With a Submerged Activation Component. A Clinical and Radiographical Study

Conditions
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Periodontitis, Alveolar Bone Loss

Intervention / Treatment
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* Device: A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acquired alveolar defects (Post extraction, Traumatic avulsion of teeth, Periodontal disease, After tumor resection), congenital alveolar defects, vertically deficient edentulous ridge in maxillary or mandibular anterior region with Allen Type A moderate vertical ridge deficiency (3-6mm) Exclusion Criteria Medically compromised patients Subjects who underwent radiotherapy or chemotherapy Smokers and Radiographic presence of less than 5mm of anterior maxillary and mandibular bone height

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distraction osteogenesis using mini distractor<br>A mini distractor will be used to move bone. Distraction osteogenesis originally developed for the severe craniofacial malformations has been adapted to correct vertical defects of the oral bone to improve bone volume for dental procedures. However, the design of the distractor has not evolved to adapt to a much smaller surgical site such as bone ridge in the oral cavity which necessitates a smaller screw. are bulky, cumbersome to place, and cause significant discomfort to the patient. has an extraoral component jutting out of the mouth to which a key (blue object) is attached to turn the screw to move bone fragments. Our Solution and the Innovation is to remove the extra-oral component by reducing the size and permitting an atraumatic placement of the screw under the gingiva (gum) thereby lessening irritation for the patient. | Device: A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT<br>* Mini distractor is used to regenerate alveolar bone which is resorbed due various reasons. The distractor uses a winch-like submucosal activation component which is buried in the tissue; Flicking the winch turns the screw which moves the segment upwards in the direction of black arrow increasing height.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height of the residual bone | In radiographs, height of the residual bone will be taken as preoperative height. The gain in height of bone will be estimated after 6-months as postoperative bone height. | From baseline to 6months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of inflammation in gingiva | Degree of inflammation: degree of inflammation around the orthodontic implant was recorded by using the modified gingival index; 0 = normal gingiva; 1 = mild inflammation- slight change in color, slight edema, no bleeding on tissue manipulation. 2 = moderate inflammation- redness, edema and bleeding on tissue manipulation 3 = severe inflammation- marked redness and edema with ulceration and tendency for spontaneous bleeding. | From baseline to 2-months |