Customized Titanium Membrane for Growing Jaw Bone Horizontally

Study Overview
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Brief Summary
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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.

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

Conditions
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Bone Gain

Intervention / Treatment
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* Device: CTI
* Device: Collagen membrane


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| linear bone gain |  | 4 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant marginal bone level |  | 18 months after baseline surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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after augmentation, procedure