Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Completed
• CT.gov ID: NCT02275767
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 3
• Duration (Months): 18
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).

Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Bone Loss	Device: 50% cortical/50% cancellous FDBA; Device: 100% cortical FDBA; Device: 100% cancellous FDBA	N/A

Detailed Description

The study is designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The study is a 3-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).

Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination 50% cortical/50% cancellous FDBA Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)	Device: 50% cortical/50% cancellous FDBA; Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
Active Comparator: 100% cortical FDBA Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)	Device: 100% cortical FDBA; Ridge preservation after tooth extraction using 100% cortical FDBA
Active Comparator: 100% cancellous FDBA Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)	Device: 100% cancellous FDBA; Ridge preservation after tooth extraction using 100% cancellous FDBA

Outcome Measures

Primary Outcome Measures

1. % Vital Bone Formation (Histological) [18-20 weeks after ridge preservation]

   histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery

Secondary Outcome Measures

1. % Residual Graft Material (Histological) [18-20 weeks after ridge preservation]

   histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery

Eligibility Criteria

Criteria

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

Inclusion Criteria: Patients will be included in this study if they qualify the following inclusion criteria:

• Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio

• Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol

• A single rooted tooth that has been identified as requiring extraction

• Desire a dental implant to replace the missing 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.

• 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.

• Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.

• Are nonsmokers or former smokers. Current smokers may only be included if they smoke <10 cigarettes per day

Exclusion Criteria:

• Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio

• Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.

• Patients will are mentally incompetent, prisoners, or pregnant.

• Pregnant women or women intending to become pregnant during the study period.

• Smokers who smoke >10 cigarettes per day

• Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.

• Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health Science Center at San Antonio, School of Dentistry	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Brian L Mealey, DDS, MS, UT Health Science Center at San Antonio, School of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02275767
• Other Study ID Numbers: HSC2014-454H
• First Posted: Oct 27, 2014
• Last Update Posted: May 11, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Alveolar Bone Loss

Study Results

Participant Flow

Arm/Group Title	Combination 50% Cortical/50% Cancellous FDBA	100% Cortical FDBA	100% Cancellous FDBA
Arm/Group Description	Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
Period Title: Overall Study
STARTED	22	22	22
COMPLETED	20	18	19
NOT COMPLETED	2	4	3

Baseline Characteristics

Arm/Group Title	Combination 50% Cortical/50% Cancellous FDBA	100% Cortical FDBA	100% Cancellous FDBA	Total
Arm/Group Description	Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA	Total of all reporting groups
Overall Participants	22	22	22	66
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54.4	52.6	53.7	53.2
Sex: Female, Male (Count of Participants)
Female	14 63.6%	13 59.1%	10 45.5%	37 56.1%
Male	8 36.4%	9 40.9%	12 54.5%	29 43.9%

Outcome Measures

1. Primary Outcome

Title	% Vital Bone Formation (Histological)
Description	histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery
Time Frame	18-20 weeks after ridge preservation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination 50% Cortical/50% Cancellous FDBA	100% Cortical FDBA	100% Cancellous FDBA
Arm/Group Description	Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
Measure Participants	20	18	19
Mean (Standard Deviation) [percentage of total area]	26.4 (13.2)	24.5 (8.6)	28.8 (14.1)

2. Secondary Outcome

Title	% Residual Graft Material (Histological)
Description	histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery
Time Frame	18-20 weeks after ridge preservation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination 50% Cortical/50% Cancellous FDBA	100% Cortical FDBA	100% Cancellous FDBA
Arm/Group Description	Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA	Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
Measure Participants	20	18	19
Mean (Standard Deviation) [percentage of total area]	23.4 (12.5)	28.1 (10.7)	18.8 (8.4)

Adverse Events

Arm/Group Title	Combination 50% Cortical/50% Cancellous FDBA		100% Cortical FDBA		100% Cancellous FDBA
Arm/Group Description	Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA) 50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA		Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA		Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA) 100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA
All Cause Mortality
	Combination 50% Cortical/50% Cancellous FDBA		100% Cortical FDBA		100% Cancellous FDBA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Combination 50% Cortical/50% Cancellous FDBA		100% Cortical FDBA		100% Cancellous FDBA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Combination 50% Cortical/50% Cancellous FDBA		100% Cortical FDBA		100% Cancellous FDBA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.