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An RCT Comparing Xenograft and Allograft for Ridge Preservation

Primary Purpose

Tooth Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

allograft + x-link collagen membrane

xenograft + non-x-link collagen

About this trial

This is an interventional treatment trial for Tooth Loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects 18 to 70-yrs of age
Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing)
Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket
Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

Subjects with a history of any tobacco use within the last six months.
Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
Subjects taking intramuscular or intravenous bisphosphonates.
Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic.
Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Sites / Locations

Perio Health Professionals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

allograft + x-link collagen membrane

xenograft + non-x-link collagen

Arm Description

Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.

Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.

Outcomes

Primary Outcome Measures

Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months

The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.

Secondary Outcome Measures

New Bone Plus Graft Content at 6-months

New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the "new healing" area.

Wound Closure at 4-weeks

Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.

Full Information

NCT ID

NCT02330523

First Posted

December 31, 2014

Last Updated

January 21, 2016

Sponsor

McGuire Institute

Collaborators

Geistlich Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT02330523

Brief Title

An RCT Comparing Xenograft and Allograft for Ridge Preservation

Official Title

A Prospective, Randomized, Controlled, Multi-center Study With Direct Measure and Histological Evaluation Comparing Xenograft and Allograft for Posterior Buccal Dehiscence Extraction Site Ridge Preservation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McGuire Institute

Collaborators

Geistlich Pharma AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.

Detailed Description

Buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (GBR) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. Many bone augmentation biomaterials are employed to accomplish GBR, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given GBR biomaterial might be more efficacious. To this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients. The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

allograft + x-link collagen membrane

Arm Type

Active Comparator

Arm Description

Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.

Arm Title

xenograft + non-x-link collagen

Arm Type

Active Comparator

Arm Description

Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.

Intervention Type

Device

Intervention Name(s)

allograft + x-link collagen membrane

Intervention Description

Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Allograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. X-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.

Intervention Type

Device

Intervention Name(s)

xenograft + non-x-link collagen

Intervention Description

Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Xenograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. Non-x-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.

Primary Outcome Measure Information:

Title

Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months

Description

The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.

Time Frame

Six Months

Secondary Outcome Measure Information:

Title

New Bone Plus Graft Content at 6-months

Description

Time Frame

Six Months

Title

Wound Closure at 4-weeks

Description

Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.

Time Frame

4-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects 18 to 70-yrs of age Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing) Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF). Subjects must be able and willing to follow study procedures and instructions. Exclusion Criteria: Subjects with a history of any tobacco use within the last six months. Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. Subjects taking intramuscular or intravenous bisphosphonates. Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental). Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric T Scheyer, DDS, MS

Organizational Affiliation

The McGuire Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Perio Health Professionals

City

Houston

State/Province

Texas

ZIP/Postal Code

77063

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22680300

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.

Results Reference

background

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An RCT Comparing Xenograft and Allograft for Ridge Preservation

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