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

NCT02275767 | Completed Results

• 1 other identifier: HSC2014-454H
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• % Vital Bone Formation (Histological)

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

  18-20 weeks after ridge preservation

Secondary Outcomes (1)

• % Residual Graft Material (Histological)

  18-20 weeks after ridge preservation

Study Arms (3)

Combination 50% cortical/50% cancellous FDBA

EXPERIMENTAL

Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)

Device: 50% cortical/50% cancellous FDBA

100% cortical FDBA

ACTIVE COMPARATOR

Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)

Device: 100% cortical FDBA

100% cancellous FDBA

ACTIVE COMPARATOR

Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)

Device: 100% cancellous FDBA

Interventions

50% cortical/50% cancellous FDBA DEVICE

Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA

Combination 50% cortical/50% cancellous FDBA

100% cortical FDBA DEVICE

Ridge preservation after tooth extraction using 100% cortical FDBA

100% cortical FDBA

100% cancellous FDBA DEVICE

Ridge preservation after tooth extraction using 100% cancellous FDBA

100% cancellous FDBA

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
• 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
• Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants

Sponsors & Collaborators

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

Study Sites (1)

UT Health Science Center at San Antonio, School of Dentistry

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Demetter RS, Calahan BG, Mealey BL. Histologic Evaluation of Wound Healing After Ridge Preservation With Cortical, Cancellous, and Combined Cortico-Cancellous Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Sep;88(9):860-868. doi: 10.1902/jop.2017.170155. Epub 2017 Apr 28.

  PMID: 28452622 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Brian L. Mealey DDS, MS
• Organization: Univ of Texas Health Sci Ctr San Antonjio, Dept of Periodontics

mealey@uthscsa.edu

210-567-3567

Study Officials

• Brian L Mealey, DDS, MS

  UT Health Science Center at San Antonio, School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 11, 2016
• Results First Posted: May 11, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)