Tooth Extraction
Conditions
Keywords
ridge preservation, tooth extraction, collagen membrane, cone-beam computed tomography
Brief summary
The resorption of alveolar ridge after tooth extraction develop difficulty in restoring the extraction area with implant or bridge. Therefore, try to preserve the alveolar ridge width and height at extraction socket and gaining its bone volume in maximal is worth for clinical investigation. There are several method to deal with alveolar ridge preservation (ARP), the most popular way for its approach, the trend is toward to minimally invasive treatment. Alveolar ridge preservation which is done with open-healed wound without primary closure is the key for minimally invasive approach. This three-armed randomized clinical trial would like to determine the effect of applying ribose cross-linked collagen membrane without primary flap closure in molar extraction sockets for alveolar ridge preservation. The procedure is for implant site development. Three groups were designed as test group1 was grafted with freeze dried bone allograft (FDBA) and covered by ribose cross-linked collagen membrane (OSSIX® PLUS). In test group2 sockets filled with collagen plug(Teruplug®) and sockets healed naturally as control group. Cone-beam computed tomography(CBCT) scans are obtained immediately and 4 months after ARP as the primary outcome and secondary outcome. A biopsy from implant site and histomorphometric analysis will be done as well. The change of marginal bone level and the width/height of keratinized mucosa are measured.
Interventions
PROCEDUREmembrane guided regeneration
after tooth extraction, the socket was filled with membrane and graft (FDBA)
PROCEDUREcollagen plug
after tooth extraction, the socket was filled with collagen plug
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age\>20 * according to periapical film, the bone defect over bucco-lingual and mesio-distal direction less than 50% * patient agreed to undergo implant therapy after tooth extraction
Exclusion criteria
* systemic diseases which will affect wound healing (ex. Diebetes) * heavy smoker (10 cigarette/day) * patient who underwent oral-maxillary surgery or who diagnosed with oral cancer * patient who is pregnant or who is breast-feeding * patient who is allergic to Lidocaine * patient who cannot cooperate the study design
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| alveolar ridge width and height in three plane | four months after surgery | mesure with CBCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gingival thickness | four months after surgery | measure with CBCT and clinical observation |
Countries
Taiwan
Contacts
Primary ContactChen-Ying Wang, PHD
Backup ContactChen-Ying Wang, PHD
Outcome results
None listed