Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants
NCT ID: NCT01909999
Last Updated: 2013-07-29
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2010-03-31
2012-12-31
Brief Summary
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Detailed Description
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The selected patients were randomly allocated (by a computer generated list) into:
Group IM - (n = 20) - patients who received placement of implants and prosthesis within a period of 3 days, characterizing immediate loading implants protocol; Group NL - (n = 20) - patients who received single-stage dental implants with no placement of dental prostheses within a period of 4 months, characterizing non-loading 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. Soft-tissue was sutured with simple interrupted sutures 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 (12-12 hours/10 days).
The patients in the IM Group received Brånemark full arch prosthesis within 3 days after the implant. All prosthesis used straight mini-abutments (SIN, São Paulo, SP) and received occlusal adjustment and a monthly clinical monitoring (including modified bleeding on probing and peri-implant probing depth).
Evaluation of osteogenic markers 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.
Statistical Analysis The null hypothesis considered in the study was the absence of difference in the peri-implant osteogenic markers concentration between the different loading protocols. For data analysis, the statistical program was used (SAS release 9.1, 2003, SAS Institute Inc., Cary, NC, USA). The demographic and clinical data were compared between the groups using Student's t-test (age), and Fisher's Exact test (gender and site of implants). The data on the levels of osteogenic markers were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. Thus, the nonparametric tests - Friedman for intragroup and Mann-Whitney for intergroup analysis, were performed. All the analysis considered α=5%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Immediate loading implants
The 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.
Implant instalation
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.
Prosthesis installation
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
Suture
Soft tissues sutures were done using absorbable polygalactin 910 suture.
Post-operative care
Postoperative care were: amoxicillin 500 mg (8-8 hours/7 days); sodic dipyrone 500mg (6-6 hours/3 days); 0.12% Chlorhexidine mouthwash"
Osteogenic markers Evaluation
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).
Clinical parameters evaluation
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.
Unloaded Implants
The variables, immunological and clinical, obtained in immediate loading groups were compared to unloaded implants, i.e., no prosthetic rehabilitation during osseointegration.
Implant instalation
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.
Suture
Soft tissues sutures were done using absorbable polygalactin 910 suture.
Post-operative care
Postoperative care were: amoxicillin 500 mg (8-8 hours/7 days); sodic dipyrone 500mg (6-6 hours/3 days); 0.12% Chlorhexidine mouthwash"
Osteogenic markers Evaluation
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).
Clinical parameters evaluation
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.
Interventions
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Implant instalation
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.
Prosthesis installation
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
Suture
Soft tissues sutures were done using absorbable polygalactin 910 suture.
Post-operative care
Postoperative care were: amoxicillin 500 mg (8-8 hours/7 days); sodic dipyrone 500mg (6-6 hours/3 days); 0.12% Chlorhexidine mouthwash"
Osteogenic markers Evaluation
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).
Clinical parameters evaluation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Renato Correa Viana Casarin
OTHER
Responsible Party
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Renato Correa Viana Casarin
DDS, MSc, PhD, Full Professor
Principal Investigators
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Renato C Casarin, PhD
Role: PRINCIPAL_INVESTIGATOR
UNIP
Locations
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Faculty of Dentistry - Paulista University
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Reile 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.
Branemark 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.
Prati 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.
Other Identifiers
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AJP2012
Identifier Type: -
Identifier Source: org_study_id
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