At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants
In Brief
A clinical study evaluating Osteogenic markers Evaluation, Clinical parameters evaluation, and 4 other interventions for Jaw, Edentulous. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The aim of this study was to compare the release of the osteoprotegerin (OPG), transforming growth factors (TGF-α), osteocalcin (OCN), osteopontin (OPN), and parathyroid hormone (PTH) during osseointegration of dental implants with and without immediate loading. Forty patients were selected and randomly divided into: Group IM - implant and prosthesis placement within 72 hours; and Group NL - implant insertion and no prosthesis placement during 120 days. Peri-implant crevicular fluid (PICF) was collected immediately after implant insertion and with 7, 15, 30, 60, 90, and 120 days after surgery and were evaluated levels of OPG, TGF-α, OCN, OPN and PTH using Luminex assay. Clinical aspects (Sulcus bleeding and peri-implant probing depth) were also assessed. The data were compared using the ANOVA/Tukey and Friedman/Mann-Whitney tests (α=5%).
Study Details
Timeline
Interventions
The collection of peri-implant crevicular fluid (PICF) was performed immediately after implant insertion (Baseline) and after 7, 15, 30, 60, 90 and 120 days. The site to be collected was dried and isolated with sterile gauze. PICF was collected at four sites per implant using absorbent paper strips (Periopaper, Oralflow, Smithtown, New York). The volume of fluid was measured immediately with the aid of Periotron (Oraflow, Smithtown, New York) and conditioned at 400uL of PBS buffer + 0.05% Tween and then frozen at -80°C. The levels of the peri-implant osteogenic markers (OPG, OCN, OPN, TGF-α, and PTH) were determined using the LUMINEX/Magpix system (HBN1A-51K and HCCBP1MAG-58K, Millipore Corporation, Billerica, MA, USA).
The following parameters were assessed: 1. Peri-implant sulcus depth (PISD): distance from the margin of the peri-implant mucosa to the bottom of the peri-implant sulcus; 2. Modified Bleeding on Probing Index: the presence or absence of bleeding after 10 seconds on probing around implants.
The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of UNIP-SP. Surgical areas were anesthetized (2% mepivacaine with 1:100,000 epinephrine) and mucoperiosteal incisions in the alveolar ridge mucosa were made. The surgical sequence follow the protocol described by the implant company supplier of implants (SIN - São Paulo, SP, BR). In all cases, for maxilla rehabilitation, 6 implants were installed, while, for mandible, 5 were used.
The patients in the IM Group received Brånemark protocol prosthesis within 3 days after the implant. The implants were first molded and the models sent for prosthesis confection (LABDENTAL, São Paulo, SP, Brazil). All prosthesis used straight mini-abutments (SIN, São Paulo, SP), that ranged from 1mm to 4mm in height, whose were tightened with 20N of torque, followed by occlusal adjustment and clinical monitoring
Soft tissues sutures were done using absorbable polygalactin 910 suture.
Postoperative care were: amoxicillin 500 mg (8-8 hours/7 days); sodic dipyrone 500mg (6-6 hours/3 days); 0.12% Chlorhexidine mouthwash"