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An RCT Comparing Xenograft and Allograft for Ridge Preservation

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ClinicalTrials.gov Identifier: NCT02330523
Recruitment Status : Completed
First Posted : January 5, 2015
Results First Posted : February 18, 2016
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
McGuire Institute

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.

Condition or disease Intervention/treatment Phase
Tooth Loss Device: allograft + x-link collagen membrane Device: xenograft + non-x-link collagen Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: allograft + x-link collagen membrane
Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Device: allograft + x-link collagen membrane
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.

Active Comparator: xenograft + non-x-link collagen
Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Device: xenograft + non-x-link collagen
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 Measures :
  1. Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months [ Time Frame: Six 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 :
  1. New Bone Plus Graft Content at 6-months [ Time Frame: Six 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.

  2. Wound Closure at 4-weeks [ Time Frame: 4-weeks ]
    Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects 18 to 70-yrs of age
  2. Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing)
  3. 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
  4. Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
  5. Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

  1. Subjects with a history of any tobacco use within the last six months.
  2. 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.
  3. Subjects taking intramuscular or intravenous bisphosphonates.
  4. Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic.
  5. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
  6. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
  7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330523


Locations
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United States, Texas
Perio Health Professionals
Houston, Texas, United States, 77063
Sponsors and Collaborators
McGuire Institute
Geistlich Pharma AG
Investigators
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Principal Investigator: Eric T Scheyer, DDS, MS The McGuire Institute

Publications:
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Responsible Party: McGuire Institute
ClinicalTrials.gov Identifier: NCT02330523     History of Changes
Other Study ID Numbers: 13530232
First Posted: January 5, 2015    Key Record Dates
Results First Posted: February 18, 2016
Last Update Posted: February 18, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases