Osseointegration Failure of Dental Implant Due to Infection, Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading
Conditions
Brief summary
2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values\<0.05 were considered statistically significant
Interventions
DEVICEDental Implant
Place a two piece zirconia dental implant on a healed ridge. At baseline, two month and crown placement take fluid samples with adsorbent paper in the per- implant crevicular fluid. At t2 and t3 repeat sample taken
Sponsors
Implantology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.
Exclusion criteria
1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osseointegration | from T0 to T2 - 2 month | measure if the healing process of bone was successful |
| Marginal bone loss | 4 month after T0 | measure bone level from T0 baseline to T3 |
| IL1b concentration | 4 month | Measure IL fluid at T0 and T2 for IL1b characterization |
| IL6 concentration | 4 month | Measure IL fluid at T0 and T2 for IL1b characterization |
| Microbiologic samples | 4 month | Measure crevicular fluid at T0 and T2 for bacteria characterization |
Contacts
Primary ContactElena cervino, DMD
Outcome results
None listed