Periosteal Inhibition Technique for Ridge Preservation A Prospective Study
NCT ID: NCT03763617
Last Updated: 2018-12-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-12-15
Study Completion Date
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The efficacy of the Periosteal Inhibition technique for socket preservation is studies against a control group in which the extraction sockets are allowed to heal without a socket preservation procedure.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Alveolar Ridge Preservation: Biologically-oriented Alveolar Ridge Preservation Vs Modified Periosteal Inhibition
NCT06784232
Alveolar Ridge Preservation
Alveolar Bone Loss
ACTIVE_NOT_RECRUITING
Peri-Implant Soft and Hard Tissue Stability Following Socket Preservation
NCT05005377
Alveolar Ridge Augmentation
Bone Transplantation
COMPLETED
NA
Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft
NCT03043885
Alveolar Ridge Preservation
COMPLETED
NA
Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft
NCT05107141
Alveolar Ridge Preservation
COMPLETED
NA
Bone Healing in Immediate Dental Implants
NCT04650763
Alveolar Bone Loss
Platelet Rich Plasma
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Socket preservation procedures have been shown to significantly reduce the loss of ridge dimension of an extraction socket. These procedures involve filling the empty socket with a bone graft material, which, serves as scaffold to limit horizontal and vertical ridge alterations. In order to contain the graft material, an occlusive barrier such as an autogenous soft tissue graft, resorbable or non-resorbable membrane, is often required. As yet, no one socket preservation technique has been proven superior to another, and none have proven totally effective in preserving ridge morphology. A net reduction of 1.5 mm in ridge width and 0.5 mm in ridge height is often observed after socket preservation procedures, which may necessitate additional hard or soft tissue augmentation to fully restore the ridge dimension.
In an animal histologic study in 2005, Araujo and Lindhe demonstrated that trauma and loss of periodontal ligament triggered an osteoclastic activity causing loss of bundle bone and modeling of the cortical bone plate. Osteoclasts are multi-nucleated cells that are responsible for bone resorption and are found on the outer layer of bone, beneath the periosteum. Osteoclasts are thought to be derived from pluripotent hematopoietic stem cells. When stimulated, these mononuclear precursors, the smallest of which is 9.5 microns in diameter, proliferate and attach to the bone surface to be resorbed, and only then fuse to form large mature multinucleated osteoclasts.
High-density polytetrafluoroethylene (d-ptfe) membranes have been used in socket preservation procedures as an occlusive barrier to contain the bone graft material.Polytetrafluoroethylene, a stable polymer and highly biocompatible, has a membrane porosity of less than 0.3 microns. It is impervious to bacteria and thus is recommended for a socket preservation technique, where a membrane is intentionally exposed.
In the present study, a high-density polytetrafluoroethylene (d-ptfe) membrane is placed between the periosteum and the buccal bone plate of an extraction socket where it will stay for a duration of 4 months, the time needed for the completion of bone forming within the socket. The goal of the non-resorbable d-ptfe membrane is to prevent the migration of precursor cells to the bone surface and thus their fusion to form osteoclast. The authors hypothesize that the passage of the precursor cells from the periosteum to the bone surface is inhibited by the small-diameter pores in the non-resorbable d-ptfe membrane. Osteolytic activity on the outer surface of the socket is thereby prevented as the precursor cells cannot form osteoclasts. The author coins the term "Periosteal Inhibition technique" for this socket preservation procedure.The study will compare dimension changes between extraction socket treated using the Periosteal Inhibition technique and those allowed to heal without a socket preservation procedure.
In an animal histologic study in 2005, Araujo and Lindhe demonstrated that trauma and loss of periodontal ligament triggered an osteoclastic activity causing loss of bundle bone and modeling of the cortical bone plate. Osteoclasts are multi-nucleated cells that are responsible for bone resorption and are found on the outer layer of bone, beneath the periosteum. Osteoclasts are thought to be derived from pluripotent hematopoietic stem cells. When stimulated, these mononuclear precursors, the smallest of which is 9.5 microns in diameter, proliferate and attach to the bone surface to be resorbed, and only then fuse to form large mature multinucleated osteoclasts.
High-density polytetrafluoroethylene (d-ptfe) membranes have been used in socket preservation procedures as an occlusive barrier to contain the bone graft material.Polytetrafluoroethylene, a stable polymer and highly biocompatible, has a membrane porosity of less than 0.3 microns. It is impervious to bacteria and thus is recommended for a socket preservation technique, where a membrane is intentionally exposed.
In the present study, a high-density polytetrafluoroethylene (d-ptfe) membrane is placed between the periosteum and the buccal bone plate of an extraction socket where it will stay for a duration of 4 months, the time needed for the completion of bone forming within the socket. The goal of the non-resorbable d-ptfe membrane is to prevent the migration of precursor cells to the bone surface and thus their fusion to form osteoclast. The authors hypothesize that the passage of the precursor cells from the periosteum to the bone surface is inhibited by the small-diameter pores in the non-resorbable d-ptfe membrane. Osteolytic activity on the outer surface of the socket is thereby prevented as the precursor cells cannot form osteoclasts. The author coins the term "Periosteal Inhibition technique" for this socket preservation procedure.The study will compare dimension changes between extraction socket treated using the Periosteal Inhibition technique and those allowed to heal without a socket preservation procedure.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Ridge Deficency
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A d-ptfe membrane is placed between the buccal bone and periosteum of an extraction socket to prevent the precursors of the bone resorbing cells (osteoclasts) from adhering to the bone surface.
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test group
A d-ptfe membrane will be placed between the buccal bone and periosteum of an extraction socket during a 4 months healing time before it is surgically removed.
Group Type
ACTIVE_COMPARATOR
d-ptfe membrane
Intervention Type
DEVICE
Socket preservation using d-ptfe membrane to inhibit the formation of osteoclasts
Control group
The extraction socket will be left to heal naturally without a socket preservation intervention.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
d-ptfe membrane
Socket preservation using d-ptfe membrane to inhibit the formation of osteoclasts
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 22 years of age
* Systemically healthy
* An extraction of one non-salvageable molar or premolar tooth is indicated. Adjacent teeth must be present to support the measuring template.
* Demonstrated ability to maintain goodoral hygiene
* Willingness and ability to commit to follow-up
* Able to understand study procedure and provide signed informed consent.
* Systemically healthy
* An extraction of one non-salvageable molar or premolar tooth is indicated. Adjacent teeth must be present to support the measuring template.
* Demonstrated ability to maintain goodoral hygiene
* Willingness and ability to commit to follow-up
* Able to understand study procedure and provide signed informed consent.
Exclusion Criteria
* Extensive damaged buccal or lingual bone plate
* Extreme alveolar ridge atrophy
* Extensive vertical bone loss
* Active infection at the extraction site
* Uncontrolled periodontal disease.
* Recent febrile illness (within 6 months) that precludes or delays participation
* Severe renal or liver diseases
* History of radiotherapy of the head and neck region
* Chemotherapy for treatment of malignant tumors at the time of the study.
* Immuno-compromised patients
* Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years.
* Use of disallowed concomitant medications.
* Pregnancy or intending to conceive during the course of the Study.
* Extreme alveolar ridge atrophy
* Extensive vertical bone loss
* Active infection at the extraction site
* Uncontrolled periodontal disease.
* Recent febrile illness (within 6 months) that precludes or delays participation
* Severe renal or liver diseases
* History of radiotherapy of the head and neck region
* Chemotherapy for treatment of malignant tumors at the time of the study.
* Immuno-compromised patients
* Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years.
* Use of disallowed concomitant medications.
* Pregnancy or intending to conceive during the course of the Study.
Minimum Eligible Age
22 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Goethe University
OTHER
Sponsor Role
collaborator
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vinh Giap Nguyen, DDS
Principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vinh Giap Nguyen, DDS, MSc
Role: PRINCIPAL_INVESTIGATOR
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
Reference Type
BACKGROUND
Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
Reference Type
BACKGROUND
Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.
Reference Type
BACKGROUND
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
Reference Type
BACKGROUND
MacBeth N, Trullenque-Eriksson A, Donos N, Mardas N. Hard and soft tissue changes following alveolar ridge preservation: a systematic review. Clin Oral Implants Res. 2017 Aug;28(8):982-1004. doi: 10.1111/clr.12911. Epub 2016 Jul 26.
Reference Type
BACKGROUND
Iocca O, Farcomeni A, Pardinas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104-114. doi: 10.1111/jcpe.12633. Epub 2016 Dec 5.
Reference Type
BACKGROUND
Willenbacher M, Al-Nawas B, Berres M, Kammerer PW, Schiegnitz E. The Effects of Alveolar Ridge Preservation: A Meta-Analysis. Clin Implant Dent Relat Res. 2016 Dec;18(6):1248-1268. doi: 10.1111/cid.12364. Epub 2015 Jul 1.
Reference Type
BACKGROUND
Hakeda Y, Kumegawa M. [Osteoclasts in bone metabolism]. Kaibogaku Zasshi. 1991 Aug;66(4):215-25. Japanese.
Reference Type
BACKGROUND
Hagenaars CE, van der Kraan AA, Kawilarang-de Haas EW, Visser JW, Nijweide PJ. Osteoclast formation from cloned pluripotent hemopoietic stem cells. Bone Miner. 1989 May;6(2):179-89. doi: 10.1016/0169-6009(89)90049-4.
Reference Type
BACKGROUND
Buckwalter JA, Glimcher MJ, Cooper RR, Recker R. Bone biology. I: Structure, blood supply, cells, matrix, and mineralization. Instr Course Lect. 1996;45:371-86. No abstract available.
Reference Type
BACKGROUND
Wagner JE, Collins D, Fuller S, Schain LR, Berson AE, Almici C, Hall MA, Chen KE, Okarma TB, Lebkowski JS. Isolation of small, primitive human hematopoietic stem cells: distribution of cell surface cytokine receptors and growth in SCID-Hu mice. Blood. 1995 Jul 15;86(2):512-23.
Reference Type
BACKGROUND
Baron R, Neff L, Tran Van P, Nefussi JR, Vignery A. Kinetic and cytochemical identification of osteoclast precursors and their differentiation into multinucleated osteoclasts. Am J Pathol. 1986 Feb;122(2):363-78.
Reference Type
BACKGROUND
Hoffmann O, Bartee BK, Beaumont C, Kasaj A, Deli G, Zafiropoulos GG. Alveolar bone preservation in extraction sockets using non-resorbable dPTFE membranes: a retrospective non-randomized study. J Periodontol. 2008 Aug;79(8):1355-69. doi: 10.1902/jop.2008.070502.
Reference Type
BACKGROUND
Laurito D, Cugnetto R, Lollobrigida M, Guerra F, Vestri A, Gianno F, Bosco S, Lamazza L, De Biase A. Socket Preservation with d-PTFE Membrane: Histologic Analysis of the Newly Formed Matrix at Membrane Removal. Int J Periodontics Restorative Dent. 2016 Nov/Dec;36(6):877-883. doi: 10.11607/prd.2114.
Reference Type
BACKGROUND
Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
Reference Type
BACKGROUND
Camargo PM, Lekovic V, Carnio J, Kenney EB. Alveolar bone preservation following tooth extraction: a perspective of clinical trials utilizing osseous grafting and guided bone regeneration. Oral Maxillofac Surg Clin North Am. 2004 Feb;16(1):9-18, v. doi: 10.1016/j.coms.2003.10.004.
Reference Type
BACKGROUND
Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
Reference Type
BACKGROUND
Serino G, Biancu S, Iezzi G, Piattelli A. Ridge preservation following tooth extraction using a polylactide and polyglycolide sponge as space filler: a clinical and histological study in humans. Clin Oral Implants Res. 2003 Oct;14(5):651-8. doi: 10.1034/j.1600-0501.2003.00970.x.
Reference Type
BACKGROUND
Guarnieri R, Aldini NN, Pecora G, Fini M, Giardino R. Medial-grade calcium sulfate hemihydrate (surgiplaster) in healing of a human extraction socket--histologic observation at 3 months: a case report. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):636-41.
Reference Type
BACKGROUND
Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets. Part 1: histomorphometric evaluations at 9 months. J Periodontol. 2000 Jun;71(6):1015-23. doi: 10.1902/jop.2000.71.6.1015.
Reference Type
BACKGROUND
Nappi JF, Lehman JA Jr. The effects of Surgicel on bone formation. Cleft Palate J. 1980 Oct;17(4):291-6.
Reference Type
BACKGROUND
Armstrong JK, Han B, Kuwahara K, Yang Z, Magyar CE, Dry SM, Atti E, Tetradis S, Fisher TC. The effect of three hemostatic agents on early bone healing in an animal model. BMC Surg. 2010 Dec 17;10:37. doi: 10.1186/1471-2482-10-37.
Reference Type
BACKGROUND
Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.
Reference Type
BACKGROUND
Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18.
Reference Type
BACKGROUND
Sanz M, Lindhe J, Alcaraz J, Sanz-Sanchez I, Cecchinato D. The effect of placing a bone replacement graft in the gap at immediately placed implants: a randomized clinical trial. Clin Oral Implants Res. 2017 Aug;28(8):902-910. doi: 10.1111/clr.12896. Epub 2016 Jun 7.
Reference Type
BACKGROUND
Chappuis V, Engel O, Shahim K, Reyes M, Katsaros C, Buser D. Soft Tissue Alterations in Esthetic Postextraction Sites: A 3-Dimensional Analysis. J Dent Res. 2015 Sep;94(9 Suppl):187S-93S. doi: 10.1177/0022034515592869. Epub 2015 Jun 30.
Reference Type
BACKGROUND
Chappuis V, Engel O, Reyes M, Shahim K, Nolte LP, Buser D. Ridge alterations post-extraction in the esthetic zone: a 3D analysis with CBCT. J Dent Res. 2013 Dec;92(12 Suppl):195S-201S. doi: 10.1177/0022034513506713. Epub 2013 Oct 24.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Assessment of Platelet Rich Fibrin Efficiency on Healing Delay and on Jawbone Osteochemonecrosis Provoked by Bisphosphonates
NCT01526915
COMPLETED
NA
3D Printed Scaffold Device for Ridge Preservation After Tooth Extraction
NCT03735199
COMPLETED
NA
Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects
NCT03715374
COMPLETED
NA
Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane
NCT01900964
COMPLETED
NA
Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes
NCT06334159
RECRUITING
NA
Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery
NCT01796119
COMPLETED
NA
Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites
NCT03215667
TERMINATED
NA
Impact of PTFE-d Barrier Intentionally Exposed to Bucal Environment in Guided Bone Regeneration to Ridge Preservation
NCT04329351
UNKNOWN
NA
Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft
NCT02707536
COMPLETED
NA
Alveolar Ridge Preservation Following Tooth Extraction.
NCT05505084
ACTIVE_NOT_RECRUITING
Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft
NCT06879171
NOT_YET_RECRUITING
NA
Regenerative Therapy of Periodontal Bone Defects
NCT03435653
UNKNOWN
NA
Horizontal Ridge Augmentation With or Without Autogenous Block Grafts
NCT03432702
COMPLETED
NA
Composite Plug Vs D-PTFE Membrane in Socket Preservation
NCT06315413
RECRUITING
NA
One Stage Ridge Splitting Using 2 Different Techniques in Maxilla
NCT06891261
RECRUITING
NA
Alveolar Ridge Preservation With Cortico-cancellous Porcine Bone
NCT06970184
ACTIVE_NOT_RECRUITING
Management of the Fresh Extraction Socket in the Aesthetic Area
NCT04367766
RECRUITING
NA
Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
NCT04299750
UNKNOWN
NA
E-PRF vs Collagen Membranes in Ridge Preservation
NCT07281053
COMPLETED
NA
Comparison of The Post-Extraction Dimensional Alterations Following Ridge Preservation Using Autogenous Partially and Completely Demineralized Dentin Grafts Versus Autogenous Whole-tooth Graft
NCT05766137
UNKNOWN
NA
Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures
NCT02602223
COMPLETED
PHASE2
Leukocyte-platelet Rich Fibrin for Alveolar Ridge Preservation
NCT05572242
UNKNOWN
NA
Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth
NCT05188196
RECRUITING
NA
Computer Guided Versus Conventional Augmentation Using Bone Ring
NCT03049137
UNKNOWN
NA