Mini Distractor in Vertically Deficient Bone

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04381585
• Other study ID #: SVSIDS/PERIO/4/2019
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 2021

Study information

• Verified date: May 2020
• Source: SVS Institute of Dental Sciences
• Contact: R V Chandra, MDS;DNB;PHD
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontitis

Intervention

Device:
• A 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.

Locations

Country	Name	City	State
India	Svs Institute of Dental Science	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From baseline to 2-months