An RCT Comparing Xenograft and Allograft for Ridge Preservation

NCT02330523 | Completed Results

• 1 other identifier: 13530232
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Six Months

Secondary Outcomes (2)

• New Bone Plus Graft Content at 6-months

  Six Months

• Wound Closure at 4-weeks

  4-weeks

Study Arms (2)

allograft + x-link collagen membrane

ACTIVE COMPARATOR

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

xenograft + non-x-link collagen

ACTIVE COMPARATOR

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

Interventions

allograft + x-link collagen membrane DEVICE

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.

allograft + x-link collagen membrane

xenograft + non-x-link collagen DEVICE

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.

xenograft + non-x-link collagen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGuire Institute: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

Perio Health Professionals

Houston, Texas, 77063, United States

Location

Related Publications (1)

• 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.

  PMID: 22680300 BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Interventions

Transplantation, Homologous; Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: E. Todd Scheyer DDS, MS
• Organization: The McGuire Institute

etsperio@swbell.net

713-783-544

Study Officials

• Eric T Scheyer, DDS, MS

  The McGuire Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 5, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 18, 2016
• Results First Posted: February 18, 2016

Record last verified: 2015-12

Locations

US (1)