Histological Comparison of Ridge Preservation Using Mineralized FDBA Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft

Tooth Extraction Clinical Trial

Official title:

Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Mineralized Freeze Dried Bone Allograft Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924390
• Other study ID #: HSC20120278H
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: October 1, 2014
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This entire protocol involves procedures that are standard care. The purpose of the research is to evaluate whether there are any differences in new bone formation following tooth extraction and grafting of the extraction socket with either 100% mineralized FDBA (FDBA) or a combination of 70% mineralized & 30% demineralized FDBA (DFDBA). Both FDBA and DFDBA are commonly used in dentistry for this purpose. Until recently, there has been no human evidence of differences in new bone formation with one material versus another. Recently, DFDBA has been shown to provide a greater percentage of vital bone formation than FDBA. No studies have been done on materials that provide a combination of demineralized and mineralized FDBA for ridge preservation. That is the purpose of this study.

There will be two subject groups in this study. All subjects will require extraction of at least one non-molar tooth, followed by replacement of the missing teeth with dental implants. Each group will have 22 subjects. The primary distinction between groups will be the use of either a combination of 70% mineralized & 30% demineralized FDBA or 100% mineralized FDBA: Group 1 will have 70% mineralized & 30% demineralized FDBA grafted into the extraction socket for ridge preservation. Group 2 will have 100% mineralized FDBA grafted into the extraction socket for ridge preservation. The allocation of subjects into group 1 or 2 will based on numbers drawn from a stack of sealed envelopes. A small flap will be reflected to an extent about 3-4mm beyond the bony walls of the socket. A measuring stent will be placed and measurements of ridge width and ridge height will be taken and recorded to the nearest 0.5mm. Ridge width will be measured using a ridge caliper at a point approximately 4mm apical to the facial and lingual bony crest. Ridge height will also be measured. The tooth will be extracted and the subject will then be randomized by drawing a sealed envelope from the stack. Either 100% mineralized FDBA or a combination of 70% mineralized & 30% demineralized FDBA will be placed in the socket to restore the ridge to appropriate contour. A dense polytetrafluoroethylene (PTFE) membrane will then be placed over the socket orifice extending about 3mm beyond the bony socket walls. A PTFE suture will be placed over the membrane to secure it in place. Primary closure will not be attempted. The patient will be seen 7-10 days after extraction/ridge preservation to assess healing. The subject will be seen again 21-28 days to remove the PTFE membrane and to assess clinical healing.

At the time of implant placement, the measuring stent and caliper will be used to determine the ridge width and ridge height again. The implant site will be prepared using a hollow trephine which allows retention of the bony core. The bone removed from the osteotomy site remaining in the trephine will be prepared for histologic examination and analyzed for new bone growth. The following histologic parameters will be measured: percent vital bone formation; percent residual graft material; and, percent nonmineralized connective tissue/bone marrow. Following initial preparation of the implant site with the trephine, an implant of the appropriate length and diameter will be placed. A healing abutment will then be placed. All subjects will be examined at 7-10 days following implant placement. The study will end at the time of this follow up visit. The patient will then be referred to his/her restorative dentist for final restoration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• single rooted tooth requiring extraction

• 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

• have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket

Exclusion Criteria:

• not meeting inclusion criteria

• active localized or systemic infection other than periodontitis.

• 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.

• sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants (per package insert)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Extraction

Intervention

Device:
• Mineralized freeze-dried bone allograft alone

• Combination of Mineralized and demineralized freeze-dried bone allograft alone

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio (Dental School)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (5)

Beck TM, Mealey BL. Histologic analysis of healing after tooth extraction with ridge preservation using mineralized human bone allograft. J Periodontol. 2010 Dec;81(12):1765-72. doi: 10.1902/jop.2010.100286. Epub 2010 Jul 27. — View Citation

Cook DC, Mealey BL. Histologic comparison of healing following tooth extraction with ridge preservation using two different xenograft protocols. J Periodontol. 2013 May;84(5):585-94. doi: 10.1902/jop.2012.120219. Epub 2012 Jun 9. — View Citation

Eskow AJ, Mealey BL. Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. J Periodontol. 2014 Apr;85(4):514-24. doi: 10.1902/jop.2013.130178. Epub 2013 May 31. — View Citation

Hoang TN, Mealey BL. Histologic comparison of healing after ridge preservation using human demineralized bone matrix putty with one versus two different-sized bone particles. J Periodontol. 2012 Feb;83(2):174-81. doi: 10.1902/jop.2011.110209. Epub 2011 Jun 21. — View Citation

Wood RA, Mealey BL. Histologic comparison of healing after tooth extraction with ridge preservation using mineralized versus demineralized freeze-dried bone allograft. J Periodontol. 2012 Mar;83(3):329-36. doi: 10.1902/jop.2011.110270. Epub 2011 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Ridge Width and Ridge Height	Ridge width and height are measured at time of tooth extraction & grafting, and again 18-20 weeks later at time of implant placement. Changes in ridge height and width are determined.	At time of implant placement, which is 18-20 weeks after grafting of extraction socket	No
Primary	Percent New Vital Bone Formation	Bone core biopsy will be evaluated histologically for percent new vital bone formation	18-20 weeks	No
Secondary	Percent Residual Graft Material and Percent Connective Tissue	Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue	18-20 weeks	No