Customized Titanium Membrane for Growing Jaw Bone Horizontally

Bone Gain Clinical Trial

Official title:

The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02227719
• Other study ID #: HUM00077102
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. They will be randomly placed into one of two treatment groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a control. The decision of which material to use will be made after an implant is placed. Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after which the implants will be surgically uncovered and restored. Outcome analyses will be performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from the implant surgery. Clinical and radiographic parameters will be compared between the two experimental groups. The primary outcome is linear increase of horizontal ridge width from direct measurements.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, age >18

• Overall good, stable health

• A single missing mandibular 1st molar for at least 3 months

Exclusion Criteria:

• Any medical conditions that may contradict implant and bone surgery or influence the outcome (detailed criteria in case report form)

• Pregnancy or lactating mothers

• Current heavy smokers (>10 cigarettes/day) or previous heavy smokers who have quit less than one year

• Unstable or unsuitable oral conditions for implant and bone surgery (detailed criteria in case report form)

Related Conditions & MeSH terms

• Bone Gain

Intervention

Device:
• CTI
CTI is the titanium mesh
• Collagen membrane

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	linear bone gain		4 months after surgery
Secondary	implant marginal bone level		18 months after baseline surgery