Customized Titanium Membrane for Growing Jaw Bone Horizontally
Status and phase
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Details and patient eligibility
About
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.
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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