Mini Distractor in Vertically Deficient Bone

Not Applicable

• Conditions: Periodontitis; Alveolar Bone Loss
• Interventions: Device: A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT

• Registration Number: NCT04381585
• Lead Sponsor: SVS Institute of Dental Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-11
• Primary Completion: 2020-10
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Distraction osteogenesis using mini distractor	A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT	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.

Primary Outcome Measures

Name	Time	Method
height of the residual bone	From baseline to 6months.	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.

Secondary Outcome Measures

Name	Time	Method
Degree of inflammation in gingiva	From baseline to 2-months	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.

Trial Locations

Locations (1)

Svs Institute of Dental Science; 🇮🇳 Hyderabad, Telangana, India