Mini Distractor in Vertically Deficient Bone

NCT04381585 | Unknown

• 1 other identifier: SVSIDS/PERIO/4/2019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontitis; Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Degree of inflammation in gingiva

  From baseline to 2-months

Study Arms (1)

Distraction osteogenesis using mini distractor

EXPERIMENTAL

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.

Device: A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT

Interventions

A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT DEVICE

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.

Distraction osteogenesis using mini distractor

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Medically compromised patients
• Subjects who underwent radiotherapy or chemotherapy
• Smokers and
• Radiographic presence of less than 5mm of anterior maxillary and mandibular bone height

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

Svs Institute of Dental Science

Hyderabad, Telangana, 509002, India

RECRUITING

MeSH Terms

Conditions

Periodontitis; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Central Study Contacts

R V Chandra, MDS;DNB;PHD

CONTACT

9908183071; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 11, 2020
• Study Start: May 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2021
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

IN (1)