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

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Completed
• CT.gov ID: NCT01924390
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Extraction	Device: Mineralized freeze-dried bone allograft alone; Device: Combination of Mineralized and demineralized freeze-dried bone allograft alone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mineralized FDBA alone Socket grafting with mineralized freeze-dried bone allograft alone	Device: Mineralized freeze-dried bone allograft alone
Experimental: Combination of mineralized and deminieralized FDBA Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone	Device: Combination of Mineralized and demineralized freeze-dried bone allograft alone

Outcome Measures

Primary Outcome Measures

1. Percent New Vital Bone Formation [18-20 weeks]

   Bone core biopsy will be evaluated histologically for percent new vital bone formation

Secondary Outcome Measures

1. Percent Residual Graft Material and Percent Connective Tissue [18-20 weeks]

   Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue

Other Outcome Measures

1. Change in Ridge Width and Ridge Height [At time of implant placement, which is 18-20 weeks after grafting of extraction socket]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at San Antonio (Dental School)	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Brian L Mealey, Graduate Program Director, Dept of Periodontics, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT01924390
• Other Study ID Numbers: HSC20120278H
• First Posted: Aug 16, 2013
• Last Update Posted: Oct 6, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Brian L Mealey, Graduate Program Director, Dept of Periodontics, The University of Texas Health Science Center at San Antonio: Tooth extraction

Study Results

Participant Flow

Arm/Group Title	Mineralized FDBA Alone	Combination of Mineralized and Demineralized FDBA
Arm/Group Description	Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Period Title: Overall Study
STARTED	22	22
COMPLETED	21	21
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Mineralized FDBA Alone	Combination of Mineralized and Demineralized FDBA	Total
Arm/Group Description	Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone	Total of all reporting groups
Overall Participants	22	22	44
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	51	53	52
Sex: Female, Male (Count of Participants)
Female	13 59.1%	15 68.2%	28 63.6%
Male	9 40.9%	7 31.8%	16 36.4%

Outcome Measures

1. Primary Outcome

Title	Percent New Vital Bone Formation
Description	Bone core biopsy will be evaluated histologically for percent new vital bone formation
Time Frame	18-20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mineralized FDBA Alone	Combination of Mineralized and Demineralized FDBA
Arm/Group Description	Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Measure Participants	21	21
Mean (Standard Deviation) [percentage of vital bone]	24.7 (16.0)	36.2 (11.9)

2. Secondary Outcome

Title	Percent Residual Graft Material and Percent Connective Tissue
Description	Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue
Time Frame	18-20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mineralized FDBA Alone	Combination of Mineralized and Demineralized FDBA
Arm/Group Description	Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Measure Participants	21	21
Mean (Standard Deviation) [percentage of residual graft]	27.0 (13.6)	18.2 (12.4)

3. Other Pre-specified Outcome

Title	Change in Ridge Width and Ridge Height
Description	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.
Time Frame	At time of implant placement, which is 18-20 weeks after grafting of extraction socket

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mineralized FDBA Alone	Combination of Mineralized and Demineralized FDBA
Arm/Group Description	Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone	Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
Measure Participants	21	21
Mean (Standard Deviation) [change in ridge width (loss of width mm)]	1.63 (1.18)	1.19 (1.36)

Adverse Events

Arm/Group Title	Mineralized FDBA Alone		Combination of Mineralized and Demineralized FDBA
Arm/Group Description	Socket grafting with mineralized freeze-dried bone allograft alone Mineralized freeze-dried bone allograft alone		Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone Combination of Mineralized and demineralized freeze-dried bone allograft alone
All Cause Mortality
	Mineralized FDBA Alone		Combination of Mineralized and Demineralized FDBA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mineralized FDBA Alone		Combination of Mineralized and Demineralized FDBA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Mineralized FDBA Alone		Combination of Mineralized and Demineralized FDBA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.