Mini Distractor in Vertically Deficient Bone

SVS Institute of Dental Sciences

Status: Unknown

Conditions: Periodontitis; Alveolar Bone Loss

Treatments: Device: A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT

Study type: Interventional

Funder types: Other

Identifiers

NCT04381585

SVSIDS/PERIO/4/2019

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Distraction osteogenesis using mini distractor

Experimental group

Description:

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 1. has not evolved to adapt to a much smaller surgical site such as bone ridge in the oral cavity which necessitates a smaller screw. 2. are bulky, cumbersome to place, and cause significant discomfort to the patient. 3. 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.

Treatment:

Device: A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT