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Mini Distractor in Vertically Deficient Bone

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04381585
Enrollment
10
Registered
2020-05-11
Start date
2019-05-01
Completion date
2021-11-30
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss, Periodontitis

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.

Interventions

DEVICEA MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT

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.

Sponsors

SVS Institute of Dental Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
height of the residual boneFrom 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

MeasureTime frameDescription
Degree of inflammation in gingivaFrom baseline to 2-monthsDegree 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.

Countries

India

Contacts

Primary ContactR V Chandra, MDS;DNB;PHD
viswachandra@hotmail.com9908183071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026