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OpenTrials
Completed

NCT Number: NCT02330523

An RCT Comparing Xenograft and Allograft for Ridge Preservation

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perio Health Professionals

Houston, Texas, 77063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

McGuire Institute

Industry

Collaborators

  • Geistlich Pharma AG

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2015
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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