Customized Titanium Membrane for Growing Jaw Bone Horizontally

NCT02227719 | Withdrawn Phase 4

• 1 other identifier: HUM00077102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Gain

Keywords

after augmentation; procedure

Outcome Measures

Primary Outcomes (1)

• linear bone gain

  4 months after surgery

Secondary Outcomes (1)

• implant marginal bone level

  18 months after baseline surgery

Study Arms (2)

Test: CTI

EXPERIMENTAL

CTI is titanium mesh

Device: CTI

Control: Collagen membrane

ACTIVE COMPARATOR

Collagen membrane is used for ridge augmentation

Device: Collagen membrane

Interventions

CTI DEVICE

CTI is the titanium mesh

Test: CTI

Collagen membrane DEVICE

Control: Collagen membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

US (1)