Atrophied Posterior Maxillary RidgeNCT02577289
Open Sinus Lift Technique With Simultaneous Implantation Using Platelet Rich Fibrin (PRF) Versus Nano-crystalline Hydroxyapatite
A study testing Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite) and Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF) in people with Atrophied Posterior Maxillary Ridge, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of bone quantity in open sinus lift technique with space maintaining using platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline hydroxyapatite with simultaneous placing of implants. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophied Posterior Maxillary Ridge
- What is being tested?
- Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite) and Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Dec 2017
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients should be seeking for implant supported prosthesis in posterior maxilla bilaterally
- All patients should have atrophied posterior maxillary ridge with the maximum height of the alveolar bone is from 3 mm to 5 mm
Who cannot join
- Ongoing steroid therapy;
- Uncontrolled diabetes;
- Recent cardiovascular diseases;
- Inflammation of the maxillary sinus;
- Previous radiant therapy for neoplastic pathologies
- Patient who have had previous failed sinus augmentation, or exhibited pathological finding or had a history of maxillary sinus disease or operations or whose medical condition might increase surgical risk of the research protocol were excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral and dental medicine
Cairo, Cairo Governorate, 11553
waleed M. Nour El din, BDS, +2-01001448723, waleed_nour@live.com
Hesham Abdel Hakm, Profeesor, +2-01156096060, surgery@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Bone Quantity in Open Sinus Lift Technique With Simultaneous Implantation Using Platelet Rich Fibrin (PRF) Versus Nano-crystalline Hydroxyapatite as Sole Grafting Material in Patients With Atrophied Posterior Maxillary Ridge
Evaluation of bone quantity in open sinus lift technique with space maintaining using platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline hydroxyapatite with simultaneous placing of implants.
Read the detailed description
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation using platelet rich fibrin (PRF) versus Nano-crystalline Hydroxyapatite as sole grafting material in patients with atrophied posterior maxillary ridge which provides a new modality for treatment of patients with atrophied posterior maxillary ridge with least cost and a much easier way using platelet rich fibrin (PRF) as substitution to bone graft
- Conditions
- Atrophied Posterior Maxillary Ridge
- Being tested
- Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite), Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)
- Keywords
- simultaneous implantation, Dental implant, Open sinus Lifting, PRF, platelet rich fibrin (PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)Procedure or surgery
- The sinus cavity will be augmented with bone graft ( Nano crystalline hydroxyapatite)
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)Procedure or surgery
platelet rich fibrin (PRF) as sole grafting material in created space (PRF)
| Study group | Role | What they receive |
|---|---|---|
| Control group ( Hydroxyappetite) | Active comparator | Patients will undergo open sinus lift using nano crystalline hydroxyapatite as augmentation material and placing implants simultaneously then evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite) Receives: Procedure: Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite) |
| Test group (PRF) | Experimental | Patients will undergo open sinus lift using PRF as sole augmentation material and placing implants simultaneously then Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF) Receives: Procedure: Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of new bone formation the sinus cavity using CBCT
the amount of new bone formation of PRF in comparison with Nano-crystalline hydroxyappetite in millimeters using cone beam computed tomography (CBCT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Atrophied Posterior Maxillary RidgeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, waleed Mohamed Mohamed Mahmoud nour el din, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577289
- Sponsor's protocol ID
- open_sinus_augmentation
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jemt T, Lekholm U. Implant treatment in edentulous maxillae: a 5-year follow-up report on patients with different degrees of jaw resorption. Int J Oral Maxillofac Implants. 1995 May-Jun;10(3):303-11.
PubMed 7615326Raghoebar GM, Batenburg RH, Timmenga NM, Vissink A, Reintsema H. Morbidity and complications of bone grafting of the floor of the maxillary sinus for the placement of endosseous implants. Mund Kiefer Gesichtschir. 1999 May;3 Suppl 1:S65-9. doi: 10.1007/PL00014520.
PubMed 10414086Misch CE. Implant design considerations for the posterior regions of the mouth. Implant Dent. 1999;8(4):376-86. doi: 10.1097/00008505-199904000-00008.
PubMed 10709483Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
PubMed 15726851Sohn DS, Lee JS, Ahn MR, Shin HI. New bone formation in the maxillary sinus without bone grafts. Implant Dent. 2008 Sep;17(3):321-31. doi: 10.1097/ID.0b013e318182f01b.
PubMed 18784532Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part III: leucocyte activation: a new feature for platelet concentrates? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e51-5. doi: 10.1016/j.tripleo.2005.07.010.
PubMed 16504851Sakka S, Coulthard P. Bone quality: a reality for the process of osseointegration. Implant Dent. 2009 Dec;18(6):480-5. doi: 10.1097/ID.0b013e3181bb840d.
PubMed 20009601Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
PubMed 16504849Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
PubMed 16504850Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
PubMed 16504852Cho JS, Ko YN, Koo HY, Kang YC. Synthesis of nano-sized biphasic calcium phosphate ceramics with spherical shape by flame spray pyrolysis. J Mater Sci Mater Med. 2010 Apr;21(4):1143-9. doi: 10.1007/s10856-009-3980-1. Epub 2010 Jan 6.
PubMed 20052521Ferraz MP, Monteiro FJ, Manuel CM. Hydroxyapatite nanoparticles: A review of preparation methodologies. J Appl Biomater Biomech. 2004 May-Aug;2(2):74-80.
PubMed 2080344020. Best SM, Porter AE, Thian ES, Huang J: Bioceramics: Past, present and for the future. J Eur Ceram Soc 28: 1319, 2008.
Bohner M, Baumgart F. Theoretical model to determine the effects of geometrical factors on the resorption of calcium phosphate bone substitutes. Biomaterials. 2004 Aug;25(17):3569-82. doi: 10.1016/j.biomaterials.2003.10.032.
PubMed 15020131von Doernberg MC, von Rechenberg B, Bohner M, Grunenfelder S, van Lenthe GH, Muller R, Gasser B, Mathys R, Baroud G, Auer J. In vivo behavior of calcium phosphate scaffolds with four different pore sizes. Biomaterials. 2006 Oct;27(30):5186-98. doi: 10.1016/j.biomaterials.2006.05.051. Epub 2006 Jun 21.
PubMed 16790273
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Quantity in Open Sinus Lift Technique With Simultaneous Implantation Using Platelet Rich Fibrin (PRF) Versus Nano-crystalline Hydroxyapatite as Sole Grafting Material in Patients With Atrophied Posterior Maxillary Ridge
- ClinicalTrials.gov ID
- NCT02577289
- Acronym / sponsor ID
- open_sinus_augmentation
- Conditions
- Atrophied Posterior Maxillary Ridge
- Keywords
- simultaneous implantation, Dental implant, Open sinus Lifting, PRF, platelet rich fibrin (PRF)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Oct 2015 (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.
Evaluation of bone quantity in open sinus lift technique with space maintaining using platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline hydroxyapatite with simultaneous placing of implants.
Detailed description
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation using platelet rich fibrin (PRF) versus Nano-crystalline Hydroxyapatite as sole grafting material in patients with atrophied posterior maxillary ridge which provides a new modality for treatment of patients with atrophied posterior maxillary ridge with least cost and a much easier way using platelet rich fibrin (PRF) as substitution to bone graft
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group ( Hydroxyappetite) | Active comparator | Procedure: Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)Patients will undergo open sinus lift using nano crystalline hydroxyapatite as augmentation material and placing implants simultaneously then evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite) |
| Test group (PRF) | Experimental | Procedure: Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)Patients will undergo open sinus lift using PRF as sole augmentation material and placing implants simultaneously then Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients should be seeking for implant supported prosthesis in posterior maxilla bilaterally
- All patients should have atrophied posterior maxillary ridge with the maximum height of the alveolar bone is from 3 mm to 5 mm
Key exclusion criteria (6 listed)
- Ongoing steroid therapy;
- Uncontrolled diabetes;
- Recent cardiovascular diseases;
- Inflammation of the maxillary sinus;
- Previous radiant therapy for neoplastic pathologies
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 |
|---|---|---|
| Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)• The sinus cavity will be augmented with bone graft ( Nano crystalline hydroxyapatite) | Procedure or surgery | Control group ( Hydroxyappetite) |
| Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)platelet rich fibrin (PRF) as sole grafting material in created space (PRF) | Procedure or surgery | Test group (PRF) |
Primary outcome
The amount of new bone formation the sinus cavity using CBCT
Time frame: 6 months
the amount of new bone formation of PRF in comparison with Nano-crystalline hydroxyappetite in millimeters using cone beam computed tomography (CBCT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Background: PubMed 7615326Jemt T, Lekholm U. Implant treatment in edentulous maxillae: a 5-year follow-up report on patients with different degrees of jaw resorption. Int J Oral Maxillofac Implants. 1995 May-Jun;10(3):303-11.
- Background: PubMed 10414086Raghoebar GM, Batenburg RH, Timmenga NM, Vissink A, Reintsema H. Morbidity and complications of bone grafting of the floor of the maxillary sinus for the placement of endosseous implants. Mund Kiefer Gesichtschir. 1999 May;3 Suppl 1:S65-9. doi: 10.1007/PL00014520.
- Background: PubMed 10709483Misch CE. Implant design considerations for the posterior regions of the mouth. Implant Dent. 1999;8(4):376-86. doi: 10.1097/00008505-199904000-00008.
- Background: PubMed 15726851Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
- Background: PubMed 18784532Sohn DS, Lee JS, Ahn MR, Shin HI. New bone formation in the maxillary sinus without bone grafts. Implant Dent. 2008 Sep;17(3):321-31. doi: 10.1097/ID.0b013e318182f01b.
- Background: PubMed 16504851Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part III: leucocyte activation: a new feature for platelet concentrates? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e51-5. doi: 10.1016/j.tripleo.2005.07.010.
- Background: PubMed 20009601Sakka S, Coulthard P. Bone quality: a reality for the process of osseointegration. Implant Dent. 2009 Dec;18(6):480-5. doi: 10.1097/ID.0b013e3181bb840d.
- Background: PubMed 16504849Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
- Background: PubMed 16504850Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
- Background: PubMed 16504852Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
- Background: PubMed 20052521Cho JS, Ko YN, Koo HY, Kang YC. Synthesis of nano-sized biphasic calcium phosphate ceramics with spherical shape by flame spray pyrolysis. J Mater Sci Mater Med. 2010 Apr;21(4):1143-9. doi: 10.1007/s10856-009-3980-1. Epub 2010 Jan 6.
- Background: PubMed 20803440Ferraz MP, Monteiro FJ, Manuel CM. Hydroxyapatite nanoparticles: A review of preparation methodologies. J Appl Biomater Biomech. 2004 May-Aug;2(2):74-80.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite) and Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF) in people with Atrophied Posterior Maxillary Ridge, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Oct 2015. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed M. Nour El Din, BDS (+2-01001448723, waleed_nour@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of new bone formation the sinus cavity using CBCT (time frame: 6 months). 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 NCT02577289, which also lists 26 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 16 Oct 2015.