Ridge Preservation Using FDBA and a Collagen Wound Dressing in Molar Sites

NCT03191448 | Completed

• 1 other identifier: HSC20150708H
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

Currently, it is not known what the dimensional changes might be following a molar site extraction which has been grafted with FDBA and covered with a collagen wound dressing. The purpose of the proposed study is to examine the clinical healing following ridge preservation using freeze dried bone allograft (FDBA) with a collagen wound dressing barrier (CollaPlug®) in a molar extraction site. I

Conditions

Tooth Extraction

Outcome Measures

Primary Outcomes (1)

• Radiographic bone width changes (in mm)

  Following extraction and ridge preservation the alveolar bone around the extraction socket will remodel and some resorption is expected. Alveolar ridge width change (in mm) at the extraction site will be recorded by means of Cone Beam Computed Tomography (CBCT)

  3 months

Secondary Outcomes (1)

• Radiographic bone height changes (in mm)

  3 months

Study Arms (1)

Ridge preservation in molar sites

EXPERIMENTAL

Patient who will need a single molar site extracted as part of their treatment will be screened and consented for this research study. Ridge preservation will be performed in single molar extraction site. The site will be grafted with freezed dried bone allograft (FDBA) and covered with a collagen wound dressing (Collaplug). This is already part of clinical standard care using FDA approved products in an FDA approved fashion. The study aims at documenting the clinical outcome of such accepted procedure more precisely and compare it existing data using other materials.

Procedure: Ridge preservation; Device: FDBA; Device: Collagen wound dressing

Interventions

Ridge preservation PROCEDURE

Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously.

Also known as: Socket preservation, Socket grafting

Ridge preservation in molar sites

FDBA DEVICE

Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug)

Ridge preservation in molar sites

Collagen wound dressing DEVICE

Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug)

Ridge preservation in molar sites

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One molar tooth that has been identified by dental faculty as requiring a single tooth extraction
• A dental implant is indicated and treatment planned to replace the missing molar tooth
• Have adequate restorative space for a dental implant-retained restoration
• Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.

You may not qualify if:

• Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
• Pregnant women or women intending to become pregnant during the study period.
• Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
• Active localized or systemic infection other than periodontitis.
• Untreated periodontal diseases
• Inadequate bone dimensions or restorative space dimensions to place a dental implant
• Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases.
• Positive medical history of endocarditis following oral or dental surgery.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Related Publications (15)

• 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

• Araujo MG, Lindhe J. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog. Clin Oral Implants Res. 2009 May;20(5):433-40. doi: 10.1111/j.1600-0501.2009.01705.x.

  PMID: 19522974 BACKGROUND

• Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.

  PMID: 18672985 BACKGROUND

• Braut V, Bornstein MM, Lauber R, Buser D. Bone dimensions in the posterior mandible: a retrospective radiographic study using cone beam computed tomography. Part 1--analysis of dentate sites. Int J Periodontics Restorative Dent. 2012 Apr;32(2):175-84.

  PMID: 22292147 BACKGROUND

• Brownfield LA, Weltman RL. Ridge preservation with or without an osteoinductive allograft: a clinical, radiographic, micro-computed tomography, and histologic study evaluating dimensional changes and new bone formation of the alveolar ridge. J Periodontol. 2012 May;83(5):581-9. doi: 10.1902/jop.2011.110365. Epub 2011 Sep 26.

  PMID: 21942791 BACKGROUND

• Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.

  PMID: 19885449 BACKGROUND

• Ferrus J, Cecchinato D, Pjetursson EB, Lang NP, Sanz M, Lindhe J. Factors influencing ridge alterations following immediate implant placement into extraction sockets. Clin Oral Implants Res. 2010 Jan;21(1):22-9. doi: 10.1111/j.1600-0501.2009.01825.x. Epub 2009 Nov 13.

  PMID: 19912273 BACKGROUND

• Huynh-Ba G, Pjetursson BE, Sanz M, Cecchinato D, Ferrus J, Lindhe J, Lang NP. Analysis of the socket bone wall dimensions in the upper maxilla in relation to immediate implant placement. Clin Oral Implants Res. 2010 Jan;21(1):37-42. doi: 10.1111/j.1600-0501.2009.01870.x.

  PMID: 20070745 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

• 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

• Oghli AA, Steveling H. Ridge preservation following tooth extraction: a comparison between atraumatic extraction and socket seal surgery. Quintessence Int. 2010 Jul-Aug;41(7):605-9.

  PMID: 20614049 BACKGROUND

• Spray JR, Black CG, Morris HF, Ochi S. The influence of bone thickness on facial marginal bone response: stage 1 placement through stage 2 uncovering. Ann Periodontol. 2000 Dec;5(1):119-28. doi: 10.1902/annals.2000.5.1.119.

  PMID: 11885170 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

• Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.

  PMID: 19929956 BACKGROUND

• Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x.

  PMID: 22211304 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Clinical

Model Details: This study will document the use of standard care treatment using FDA approved material used in an FDA approved fashion.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: November 11, 2015
• Primary Completion: April 6, 2018
• Study Completion: April 6, 2018
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share