Customized Titanium Membrane for Growing Jaw Bone Horizontally

Phase 4

Withdrawn

• Conditions: Bone Gain
• Interventions: Device: Collagen membrane; Device: CTI

• Registration Number: NCT02227719
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-28
• Study Start: 2015-09
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female, age >18
• Overall good, stable health
• A single missing mandibular 1st molar for at least 3 months

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Collagen membrane	Collagen membrane	Collagen membrane is used for ridge augmentation
Test: CTI	CTI	CTI is titanium mesh

Primary Outcome Measures

Name	Time	Method
linear bone gain	4 months after surgery

Secondary Outcome Measures

Name	Time	Method
implant marginal bone level	18 months after baseline surgery

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States