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Mini Distractor in Vertically Deficient Bone

Primary Purpose

Periodontitis, Alveolar Bone Loss

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT
Sponsored by
SVS Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Svs Institute of Dental ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Distraction osteogenesis using mini distractor

Arm 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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 29, 2020
Last Updated
May 5, 2020
Sponsor
SVS Institute of Dental Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04381585
Brief Title
Mini Distractor in Vertically Deficient Bone
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Alveolar Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distraction osteogenesis using mini distractor
Arm Type
Experimental
Arm 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 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.
Intervention Type
Device
Intervention Name(s)
A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT
Intervention Description
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.
Primary Outcome Measure Information:
Title
height of the residual bone
Description
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.
Time Frame
From baseline to 6months.
Secondary Outcome Measure Information:
Title
Degree of inflammation in gingiva
Description
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.
Time Frame
From baseline to 2-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R V Chandra, MDS;DNB;PHD
Phone
9908183071
Email
viswachandra@hotmail.com
Facility Information:
Facility Name
Svs Institute of Dental Science
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R V Chandra, MDS;DNB;PHD
Phone
9908183071
Email
viswachandra@hotmail.com

12. IPD Sharing Statement

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Mini Distractor in Vertically Deficient Bone

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