Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants
1 other identifier
interventional
40
1 country
1
Brief 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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 22, 2013
CompletedFirst Posted
Study publicly available on registry
July 29, 2013
CompletedJuly 29, 2013
July 1, 2013
2.6 years
July 22, 2013
July 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ostegenic markers concentration
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 samples were analyzed individually and the levels were estimated using a 5-parameter polynomial curve in the Xponent® software (Millipore Corporation, Billerica, MA). The concentration values were expressed in pg/ml.
The osteogenic markers were assessed immediatelly after implant installation until 120 days after prothesis instalation
Secondary Outcomes (2)
Peri-implant sulcus depth (PISD)
The PISD was assessed from 30 days after implants installation until 120 days after implant/prothesis installation
Modified Bleeding on Probing Index (MBPI)
The MPBI index was evaluated from 30 days after implants/prothesis installation and at 60, 90 and 120 days.
Study Arms (2)
Immediate loading implants
EXPERIMENTALThe clinical and immunological comparisons compared implants that received Immediate loading prosthesis, i.e., full arch Branemark protocol prosthesis installed within 3 days after surgery, with unloaded implants.
Unloaded Implants
ACTIVE COMPARATORThe variables, immunological and clinical, obtained in immediate loading groups were compared to unloaded implants, i.e., no prosthetic rehabilitation during osseointegration.
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"
Eligibility Criteria
You may qualify if:
- patients with mandibular and/or maxillary edentulous arch indicated for rehabilitation with dental implants
- extractions had to occur at least 4 months prior to treatment
- good oral hygiene (plaque index \< 20%) (Ainamo \& Bay, 1975)
- age between 18-65 years
You may not qualify if:
- presence of systemic disease (including diabetes, arthritis, hypothyroidism, osteoporosis, etc) or use of medication (six months prior to the study) that contraindicated placement or alter implants osseointegration
- use of anti-inflammatory three months before surgery
- patients submitted to bone grafts in the site selected for the implant
- pregnant or breastfeeding women
- smokers or ex-smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry - Paulista University
São Paulo, São Paulo, 04026-002, Brazil
Related Publications (4)
Sato R, Matsuzaka K, Kokubu E, Inoue T. Immediate loading after implant placement following tooth extraction up-regulates cellular activity in the dog mandible. Clin Oral Implants Res. 2011 Dec;22(12):1372-8. doi: 10.1111/j.1600-0501.2010.02118.x. Epub 2011 Mar 8.
PMID: 21382088BACKGROUNDReile H, Birnbock H, Bernhardt G, Spruss T, Schonenberger H. Computerized determination of growth kinetic curves and doubling times from cells in microculture. Anal Biochem. 1990 Jun;187(2):262-7. doi: 10.1016/0003-2697(90)90454-h.
PMID: 2382827BACKGROUNDBranemark PI, Engstrand P, Ohrnell LO, Grondahl K, Nilsson P, Hagberg K, Darle C, Lekholm U. Branemark Novum: a new treatment concept for rehabilitation of the edentulous mandible. Preliminary results from a prospective clinical follow-up study. Clin Implant Dent Relat Res. 1999;1(1):2-16. doi: 10.1111/j.1708-8208.1999.tb00086.x.
PMID: 11359307BACKGROUNDPrati AJ, Casati MZ, Ribeiro FV, Cirano FR, Pastore GP, Pimentel SP, Casarin RC. Release of bone markers in immediately loaded and nonloaded dental implants: a randomized clinical trial. J Dent Res. 2013 Dec;92(12 Suppl):161S-7S. doi: 10.1177/0022034513504951. Epub 2013 Oct 24.
PMID: 24158337DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renato C Casarin, PhD
UNIP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DDS, MSc, PhD, Full Professor
Study Record Dates
First Submitted
July 22, 2013
First Posted
July 29, 2013
Study Start
March 1, 2010
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
July 29, 2013
Record last verified: 2013-07