Jaw, EdentulousNCT01909999
Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants
A study testing Osteogenic markers Evaluation, Clinical parameters evaluation and Implant instalation in people with Jaw, Edentulous, run by Renato Correa Viana Casarin at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Osteogenic markers Evaluation, Clinical parameters evaluation and Implant instalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Dentistry - Paulista University
São Paulo, São Paulo, 04026-002
About this study
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%).
Read the detailed description
This was a prospective, parallel and controlled clinical-laboratory trial. The population evaluated in this study was selected at the Graduate Clinic in Dental Implantology - UNIP-SP.
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
- Jaw, Edentulous
- Being tested
- Osteogenic markers Evaluation, Clinical parameters evaluation, Implant instalation, Prosthesis installation, Suture
- Keywords
- Dental Implants, Osseointegration, Immediate Dental Implant Loading, Bone formation
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteogenic markers EvaluationProcedure or surgery
Also called Osteoprotegerin, Osteopontin, Osteocalcin, PTH
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 evaluationProcedure or surgery
Also called Peri-implant probing depth, Bleeding index
The following parameters were assessed:
- Peri-implant sulcus depth (PISD): distance from the margin of the peri-implant mucosa to the bottom of the peri-implant sulcus;
- Modified Bleeding on Probing Index: the presence or absence of bleeding after 10 seconds on probing around implants.
Implant instalationProcedure or surgery
Also called Dental implants, Jaws rehabilitation
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 installationProcedure or surgery
Also called Brånemark protocol, Full arch rehabilitation, Implant supported prosthesis
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
SutureProcedure or surgery
Soft tissues sutures were done using absorbable polygalactin 910 suture.
Post-operative careDrug
Postoperative care were: amoxicillin 500 mg (8-8 hours/7 days); sodic dipyrone 500mg (6-6 hours/3 days); 0.12% Chlorhexidine mouthwash"
| Study group | Role | What they receive |
|---|---|---|
| Immediate loading implants | Experimental | 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. Receives: Procedure: Osteogenic markers Evaluation; Procedure: Clinical parameters evaluation; Procedure: Implant instalation; Procedure: Prosthesis installation; Procedure: Suture; Drug: Post-operative care |
| Unloaded Implants | Active comparator | The variables, immunological and clinical, obtained in immediate loading groups were compared to unloaded implants, i.e., no prosthetic rehabilitation during osseointegration. Receives: Procedure: Osteogenic markers Evaluation; Procedure: Clinical parameters evaluation; Procedure: Implant instalation; Procedure: Suture; Drug: Post-operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 parameter is part of the clinical examination done at implants included in this research. PISD was performed using a plastic probe (Colorvue, Hu-Friedy, Chicago, USA) by a single examiner (AJP), at the 2 most anterior implants in the protocol. For its determination 4 regions per implant - mesial-buccal (MB), mesial-lingual (ML), disto-buccal (DB) and disto-lingual (DL) regions - were used. The calibration of the examiner was performed on 2 different days, at least 24 hours apart, by peri-implant examination (peri-implant probing depth) in 10 non-participating subjects. The intraclass correlation index for this variable was 85%.
The Peri-implant sulcus depth (PISD) was defined as: distance from the margin of the peri-implant mucosa to the bottom of the peri-implant sulcus;
Measured: The PISD was assessed from 30 days after implants installation until 120 days after implant/prothesis installation
Modified Bleeding on Probing Index (MBPI)
The same examiner performing PISD did the Modified Bleeding on Probing Index, determined as the presence or absence of bleeding after 10 seconds on probing around implants.
Measured: The MPBI index was evaluated from 30 days after implants/prothesis installation and at 60, 90 and 120 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startMar 2010
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renato Correa Viana Casarin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Renato Correa Viana Casarin, Paulista University
- Investigators
- Renato C Casarin, PhD, Principal investigator, UNIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909999
- Sponsor's protocol ID
- AJP2012
- Status last verified
- Jul 2013
- First submitted
- 22 Jul 2013
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21382088Reile 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.
PubMed 2382827Branemark 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.
PubMed 11359307Prati 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.
PubMed 24158337
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants
- ClinicalTrials.gov ID
- NCT01909999
- Acronym / sponsor ID
- AJP2012
- Conditions
- Jaw, Edentulous
- Keywords
- Dental Implants, Osseointegration, Immediate Dental Implant Loading, Bone formation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Renato Correa Viana CasarinUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Detailed description
This was a prospective, parallel and controlled clinical-laboratory trial. The population evaluated in this study was selected at the Graduate Clinic in Dental Implantology - UNIP-SP.
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%.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate loading implants | Experimental | Procedure: Osteogenic markers Evaluation, Procedure: Clinical parameters evaluation, Procedure: Implant instalation, Procedure: Prosthesis installation, Procedure: Suture, Drug: Post-operative careThe 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 comparator | Procedure: Osteogenic markers Evaluation, Procedure: Clinical parameters evaluation, Procedure: Implant instalation, Procedure: Suture, Drug: Post-operative careThe variables, immunological and clinical, obtained in immediate loading groups were compared to unloaded implants, i.e., no prosthetic rehabilitation during osseointegration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteogenic markers EvaluationAlso: Osteoprotegerin, Osteopontin, Osteocalcin, PTHThe 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). | Procedure or surgery | Immediate loading implants, Unloaded Implants |
| Clinical parameters evaluationAlso: Peri-implant probing depth, Bleeding indexThe 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. | Procedure or surgery | Immediate loading implants, Unloaded Implants |
| Implant instalationAlso: Dental implants, Jaws rehabilitationThe 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. | Procedure or surgery | Immediate loading implants, Unloaded Implants |
| Prosthesis installationAlso: Brånemark protocol, Full arch rehabilitation, Implant supported prosthesisThe 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 | Procedure or surgery | Immediate loading implants |
| SutureSoft tissues sutures were done using absorbable polygalactin 910 suture. | Procedure or surgery | Immediate loading implants, Unloaded Implants |
| Post-operative carePostoperative care were: amoxicillin 500 mg (8-8 hours/7 days); sodic dipyrone 500mg (6-6 hours/3 days); 0.12% Chlorhexidine mouthwash" | Drug | Immediate loading implants, Unloaded Implants |
Primary outcome
Ostegenic markers concentration
Time frame: The osteogenic markers were assessed immediatelly after implant installation until 120 days after prothesis instalation
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.
2 secondary outcomes
Peri-implant sulcus depth (PISD)
Time frame: The PISD was assessed from 30 days after implants installation until 120 days after implant/prothesis installation
Modified Bleeding on Probing Index (MBPI)
Time frame: The MPBI index was evaluated from 30 days after implants/prothesis installation and at 60, 90 and 120 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
- Background: PubMed 21382088Sato 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.
- Background: PubMed 2382827Reile 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.
- Background: PubMed 11359307Branemark 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.
- Derived from this study: PubMed 24158337Prati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato C Casarin, PhD principal investigator
UNIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteogenic markers Evaluation, Clinical parameters evaluation and Implant instalation in people with Jaw, Edentulous, run by Renato Correa Viana Casarin at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ostegenic markers concentration (time frame: The osteogenic markers were assessed immediatelly after implant installation until 120 days after prothesis instalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01909999, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.