Graft LossNCT03412838

Factors Influencing Bone Block Allograft Resorption

A study testing graft surgery in people with Graft Loss, run by Universidad Complutense de Madrid.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Graft Loss
What is being tested?: graft surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: No sites listed yet
Study dates: Jan 2011to Jun 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Twenty eight totally and partially edentulous patients referred for dental implant therapy from January 2011 to September 2015 were enrolled in the study. All patients had insufficient bucco-lingual (BL) alveolar bone width (<4 mm) that prevented placement of regular size implants

Who cannot join

Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study. In addition, patients who were pregnant, or patients with diseases affecting bone, such as Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.

About this study

Official title: Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial

Read the detailed description

Introduction: A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.

Materials and methods: Twenty-eight patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study. Patients received freeze dried bone allograft (FDBA) blocks of either allogeneic cancellous or cortico-cancellous bone obtained from the iliac crest. The aforementioned groups were compared in regards to bone resorption using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site were also analyzed.

Conditions: Graft Loss
Being tested: graft surgery
Keywords: Bone block allograft, Bone density, Graft resorption, PRP, RCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

graft surgeryProcedure or surgery
A graft surgery using bone allogenic blocks that are screwed over the atrophic sites of the maxilla to obtain bone augmentation to support dental implants

Study groups in NCT03412838
Study group	Role	What they receive
Cortico-Cancellous	Active comparator	Graft surgery with cortico-cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement Receives: Procedure: graft surgery
Cancellous	Active comparator	Graft surgery with cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement Receives: Procedure: graft surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Bone Augmentation
A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.
Measured: 0 months

Secondary outcomes (1)

Percentage of bone resorption
A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jun 2015

First posted26 Jan 2018
Study startJan 2011
Primary completionJan 2011
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (52)Papers the sponsor has linked to this study.
Other trials for Graft LossStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Twenty-eight patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (\<4 mm) were included in the study. Patients received freeze dried bone allograft (FDBA) blocks of either allogeneic cancellous or cortico-cancellous bone obtained from the iliac crest. Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the cortico-cancellous group (CC), and cancellous group (C).
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03412838
Sponsor's protocol ID: P-15/566
Status last verified: Jan 2018
First submitted: 14 Jan 2018
Last updated: 26 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fu JH, Wang HL. Horizontal bone augmentation: the decision tree. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):429-36.
PubMed 21837309
Nevins M, Mellonig JT. The advantages of localized ridge augmentation prior to implant placement: a staged event. Int J Periodontics Restorative Dent. 1994 Apr;14(2):96-111.
PubMed 7928133
Lundgren S, Sjostrom M, Nystrom E, Sennerby L. Strategies in reconstruction of the atrophic maxilla with autogenous bone grafts and endosseous implants. Periodontol 2000. 2008;47:143-61. doi: 10.1111/j.1600-0757.2008.00265.x. No abstract available.
PubMed 18412579
Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
PubMed 15839587
Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76.
PubMed 9425757
McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.
PubMed 17335361
Zmolek JC, Dorr LD. Revision total hip arthroplasty. The use of solid allograft. J Arthroplasty. 1993 Aug;8(4):361-70. doi: 10.1016/s0883-5403(06)80034-3.
PubMed 8409987
Haddad FS, Spangehl MJ, Masri BA, Garbuz DS, Duncan CP. Circumferential allograft replacement of the proximal femur. A critical analysis. Clin Orthop Relat Res. 2000 Feb;(371):98-107. doi: 10.1097/00003086-200002000-00011.
PubMed 10693554
Chiapasco M, Colletti G, Coggiola A, Di Martino G, Anello T, Romeo E. Clinical outcome of the use of fresh frozen allogeneic bone grafts for the reconstruction of severely resorbed alveolar ridges: preliminary results of a prospective study. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):450-60. doi: 10.11607/jomi.3763.
PubMed 25830406
Barone A, Varanini P, Orlando B, Tonelli P, Covani U. Deep-frozen allogeneic onlay bone grafts for reconstruction of atrophic maxillary alveolar ridges: a preliminary study. J Oral Maxillofac Surg. 2009 Jun;67(6):1300-6. doi: 10.1016/j.joms.2008.12.043.
PubMed 19446220
Peleg M, Sawatari Y, Marx RN, Santoro J, Cohen J, Bejarano P, Malinin T. Use of corticocancellous allogeneic bone blocks for augmentation of alveolar bone defects. Int J Oral Maxillofac Implants. 2010 Jan-Feb;25(1):153-62.
PubMed 20209198
Waasdorp J, Reynolds MA. Allogeneic bone onlay grafts for alveolar ridge augmentation: a systematic review. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):525-31.
PubMed 20556251
Ehrler DM, Vaccaro AR. The use of allograft bone in lumbar spine surgery. Clin Orthop Relat Res. 2000 Feb;(371):38-45. doi: 10.1097/00003086-200002000-00005.
PubMed 10693548
Contar CM, Sarot JR, Bordini J Jr, Galvao GH, Nicolau GV, Machado MA. Maxillary ridge augmentation with fresh-frozen bone allografts. J Oral Maxillofac Surg. 2009 Jun;67(6):1280-5. doi: 10.1016/j.joms.2008.11.010.
PubMed 19446217
Acocella A, Bertolai R, Ellis E 3rd, Nissan J, Sacco R. Maxillary alveolar ridge reconstruction with monocortical fresh-frozen bone blocks: a clinical, histological and histomorphometric study. J Craniomaxillofac Surg. 2012 Sep;40(6):525-33. doi: 10.1016/j.jcms.2011.09.004. Epub 2011 Nov 9.
PubMed 22075326

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
Active, not recruiting
Sleeved vs. Sleeveless Guides for Immediate Implant Placement
Tooth Loss, Maxillary Premolar Area

All Graft Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03412838
Acronym / sponsor ID: P-15/566
Conditions: Graft Loss
Keywords: Bone block allograft, Bone density, Graft resorption, PRP, RCT
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Universidad Complutense de MadridUniversity, hospital or other
Study start: Jan 2011
Primary completion: Jan 2011 (actual)
Study completion: Jun 2015 (actual)
First posted: 26 Jan 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Twenty-eight patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study. Patients received freeze dried bone allograft (FDBA) blocks of either allogeneic cancellous or cortico-cancellous bone obtained from the iliac crest. Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the cortico-cancellous group (CC), and cancellous group (C).

Arm	Type	Receives
Cortico-Cancellous	Active comparator	Procedure: graft surgeryGraft surgery with cortico-cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
Cancellous	Active comparator	Procedure: graft surgeryGraft surgery with cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Twenty eight totally and partially edentulous patients referred for dental implant therapy from January 2011 to September 2015 were enrolled in the study. All patients had insufficient bucco-lingual (BL) alveolar bone width (<4 mm) that prevented placement of regular size implants

Key exclusion criteria (1 listed)

Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study. In addition, patients who were pregnant, or patients with diseases affecting bone, such as Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.

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
graft surgeryA graft surgery using bone allogenic blocks that are screwed over the atrophic sites of the maxilla to obtain bone augmentation to support dental implants	Procedure or surgery	Cancellous, Cortico-Cancellous

Primary outcome

Percentage of Bone Augmentation
Time frame: 0 months
A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.

1 secondary outcome

Percentage of bone resorption
Time frame: 4 months

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 26 Jan 2018.
Background: PubMed 21837309Fu JH, Wang HL. Horizontal bone augmentation: the decision tree. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):429-36.
Background: PubMed 7928133Nevins M, Mellonig JT. The advantages of localized ridge augmentation prior to implant placement: a staged event. Int J Periodontics Restorative Dent. 1994 Apr;14(2):96-111.
Background: PubMed 18412579Lundgren S, Sjostrom M, Nystrom E, Sennerby L. Strategies in reconstruction of the atrophic maxilla with autogenous bone grafts and endosseous implants. Periodontol 2000. 2008;47:143-61. doi: 10.1111/j.1600-0757.2008.00265.x. No abstract available.
Background: PubMed 15839587Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
Background: PubMed 9425757Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76.
Background: PubMed 17335361McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.
Background: PubMed 8409987Zmolek JC, Dorr LD. Revision total hip arthroplasty. The use of solid allograft. J Arthroplasty. 1993 Aug;8(4):361-70. doi: 10.1016/s0883-5403(06)80034-3.
Background: PubMed 10693554Haddad FS, Spangehl MJ, Masri BA, Garbuz DS, Duncan CP. Circumferential allograft replacement of the proximal femur. A critical analysis. Clin Orthop Relat Res. 2000 Feb;(371):98-107. doi: 10.1097/00003086-200002000-00011.
Background: PubMed 25830406Chiapasco M, Colletti G, Coggiola A, Di Martino G, Anello T, Romeo E. Clinical outcome of the use of fresh frozen allogeneic bone grafts for the reconstruction of severely resorbed alveolar ridges: preliminary results of a prospective study. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):450-60. doi: 10.11607/jomi.3763.
Background: PubMed 19446220Barone A, Varanini P, Orlando B, Tonelli P, Covani U. Deep-frozen allogeneic onlay bone grafts for reconstruction of atrophic maxillary alveolar ridges: a preliminary study. J Oral Maxillofac Surg. 2009 Jun;67(6):1300-6. doi: 10.1016/j.joms.2008.12.043.
Background: PubMed 20209198Peleg M, Sawatari Y, Marx RN, Santoro J, Cohen J, Bejarano P, Malinin T. Use of corticocancellous allogeneic bone blocks for augmentation of alveolar bone defects. Int J Oral Maxillofac Implants. 2010 Jan-Feb;25(1):153-62.
Background: PubMed 20556251Waasdorp J, Reynolds MA. Allogeneic bone onlay grafts for alveolar ridge augmentation: a systematic review. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):525-31.
Individual participant dataSharing planned: No

Related trials for Graft Loss

Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
Active, not recruiting
Sleeved vs. Sleeveless Guides for Immediate Implant Placement
Tooth Loss, Maxillary Premolar Area

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.

Jesus Torres principal investigator

Universidad Complutense de Madrid

Questions about this trial

What is this clinical trial studying?

A study testing graft surgery in people with Graft Loss, run by Universidad Complutense de Madrid.

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 1 inclusion and 1 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Percentage of Bone Augmentation (time frame: 0 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 NCT03412838, which also lists 52 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 26 Jan 2018.