Periosteal Inhibition Technique for Ridge Preservation A Prospective Study

NCT03763617 | Completed DMC

• 1 other identifier: PI2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ridge Deficency

Keywords

Socket preservation

Outcome Measures

Primary Outcomes (3)

• Ridge widths

  Bucco-lingual ridge dimensions at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction intra-op and 4 months post-extraction, using a acrylic template for repeatable measurements.

  0 hour and 4 months

• Change in Ridge widths on the buccal and lingual aspects

  Buccal and lingual ridge dimension change at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction and 4 months post-extraction, using a acrylic template for repeatable measurements.

  0 hour and 4 months

• Change in Ridge heights

  Change in Ridge bone heights at messiah and distal interproximal, mid-buccal and mid-lingual aspects.

  0 hour and 4 months

Secondary Outcomes (2)

• Bone plate thickness

  0 hour

• Keratinized mucosa

  0 hour and 4 months

Other Outcomes (1)

• Complications

  1 month, 2 months, 3 months and 4 months

Study Arms (2)

Test group

ACTIVE COMPARATOR

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.

Device: d-ptfe membrane

Control group

NO INTERVENTION

The extraction socket will be left to heal naturally without a socket preservation intervention.

Interventions

d-ptfe membrane DEVICE

Socket preservation using d-ptfe membrane to inhibit the formation of osteoclasts

Test group

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Dentaire et d'implantologie Dr.Vinh Nguyen: lead
• Goethe University: collaborator

Study Sites (1)

Clinique Dentaire et d'implantology Dr. Vinh Nguyen

Brossard, Quebec, J4W2T4, Canada

Location

Related Publications (27)

• 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.

  PMID: 12956475 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.

  PMID: 22211303 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.

  PMID: 27788625 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.

  PMID: 15691354 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.

  PMID: 27458031 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.

  PMID: 27712001 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.

  PMID: 26132885 BACKGROUND

• Hakeda Y, Kumegawa M. [Osteoclasts in bone metabolism]. Kaibogaku Zasshi. 1991 Aug;66(4):215-25. Japanese.

  PMID: 1759556 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.

  PMID: 2788471 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.

  PMID: 8727757 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.

  PMID: 7541665 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.

  PMID: 3946557 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.

  PMID: 18672984 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.

  PMID: 27740650 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.

  PMID: 12931761 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.

  PMID: 18088709 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.

  PMID: 16515093 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.

  PMID: 12969370 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.

  PMID: 16161750 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.

  PMID: 10914806 BACKGROUND

• Nappi JF, Lehman JA Jr. The effects of Surgicel on bone formation. Cleft Palate J. 1980 Oct;17(4):291-6.

  PMID: 6934043 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.

  PMID: 21167039 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.

  PMID: 15882225 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.

  PMID: 19922492 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.

  PMID: 27273298 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.

  PMID: 26130259 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.

  PMID: 24158340 BACKGROUND

Study Officials

• Vinh Giap Nguyen, DDS, MSc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2018
• First Posted: December 4, 2018
• Study Start: September 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 15, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

CA (1)