Implant Therapy Clinical Trial
— Implant_boneOfficial title:
Preservation of Alveolar Crestal Bone From Implant Placement to Implant Exposure Using Autologous Alveolar Bone-Marrow Derived Mesenchymal Stem Cells (aBM-MSCs)
Verified date | October 2018 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Systemically healthy volunteers with no active periodontal disease are recruited from referrals to the Dept. of Preventive Dentistry, Periodontology and Biology of Implants, Aristotle Univ of Thessaloniki for implant therapy. After signing a consent form, participants will be randomized into two treatment groups. Group-A (NA=10) will receive crestal placement of implants following a two-stage protocol in combination with a biocomplex comprising autologous alveolar bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with autologous fibrin glue. In Group-B (NB=10) implants are placed on the alveolar crest following a two-stage protocol and the manufacturer's guidelines. Intra-surgical clinical and radiographic assessments are performed at the time of implant placement (T0) and at the two-stage surgery (T1). Changes in mucosa thickness, width of keratinized tissues, marginal bone and bone thickness at the surgical site will be determined at T0-T1. Groups will be further divided into two subgroups based on mucosal thickness of the surgical site at T0 [thin mucosa (≤2.5mm) for Groups-AI/-BI; thick mucosa (>2.5mm) for Groups-AII/-BII]. A linear mixed model for repeated measures will be used for data analyses to determine changes in the dimensions of the peri-implant soft and hard tissues, around two stage-implants placed either conventionally, or in combination with the biocomplex.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: • systemically healthy volunteers Exclusion Criteria: - poorly controlled systemic disease - heavy smoking (>20cigs/day) - bisphosphonate medication - anti-inflammatory drugs - bone metabolic diseases or disorders that compromise wound healing - immunosuppressive therapy or radiation - alcohol intake - drug abuse over the past year - significant concurrent illness - pregnancy/lactation - active periodontal disease and compromised oral hygiene (PI =25%) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Aristotle University Of Thessaloniki |
Bakopoulou A, Leyhausen G, Volk J, Koidis P, Geurtsen W. Comparative characterization of STRO-1(neg)/CD146(pos) and STRO-1(pos)/CD146(pos) apical papilla stem cells enriched with flow cytometry. Arch Oral Biol. 2013 Oct;58(10):1556-68. doi: 10.1016/j.archoralbio.2013.06.018. Epub 2013 Jul 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A reduction in the marginal bone levels | Intra-surgical clinical data: Changes in the vertical distance from the implant shoulder to the alveolar crest in mm | baseline (implant placement) to 4 months (implant exposure) | |
Secondary | Radiographic changes in the marginal bone levels | Radiographic data: linear measurements (mm) on standardised x-rays regarding vertical changes in the marginal bone levels from implant shoulder to the alveolar crest | baseline (implant placement) to 4 months (implant exposure) | |
Secondary | Reduction in the thickness of the buccal/lingual bone | Clinical data: Changes in the thickness of the bone plates in the buccal/lingual aspects of the implant | baseline (implant placement) to 4 months (implant exposure) | |
Secondary | Changes in the alveolar mucosa | Changes in the thickness of mucosa at the top of the alveolar ridge and at 2- and 4mm apically of the implant shoulder | baseline (implant placement) to 4 months (implant exposure) | |
Secondary | Changes in the width of keratised mucosa | Changes in the width of keratinised mucosa in mm at the surgical site | baseline (implant placement) to 4 months (implant exposure) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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