Customized Titanium Membrane for Growing Jaw Bone Horizontally

December 4, 2023 updated by: Hsun-Liang Chan, University of Michigan

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test: CTI
CTI is titanium mesh
Device: CTI
CTI is the titanium mesh
Active Comparator: Control: Collagen membrane
Collagen membrane is used for ridge augmentation
Device: Collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
linear bone gain
Time Frame: 4 months after surgery
4 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
implant marginal bone level
Time Frame: 18 months after baseline surgery
18 months after baseline surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimated)

August 28, 2014

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00077102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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