Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts

Alveolar Bone Loss Clinical Trial

Official title:

Ridge Preservation Following Tooth Extraction Using Mineralized Freeze-Dried Bone Allograft Compared to PUROS Mineralized Bone Allograft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515058
• Other study ID #: 15-0552H
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: December 18, 2017
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: November 2017
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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.

Description:

The study is designed to examine histologic wound healing following ridge preservation using cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). 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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Device:
• PUROS (Ridge Preservation bone grafting surgery)
Ridge preservation bone grafting after tooth extraction
• FDBA (Ridge Preservation bone grafting surgery)
Ridge preservation bone grafting after tooth extraction

Locations

Country	Name	City	State
United States	UT Health Science Center at San Antonio, School of Dentistry	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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Vital Bone Formation (Histological)	histologic determination of % of vital bone formation	3 months after ridge preservation
Secondary	% Residual Graft Material (Histological)	histologic determination of % of residual bone graft material	3 months after ridge preservation