A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management

Status unconfirmed · Not applicable

Conditions studied: Tooth Loss

In brief

A prospective RCT of intact extractions with delayed implant placement comparing extraction socket management effectiveness and office economics of two collagen matrices. Soft tissue wound healing will be assessed out to 4-months post-operative, when implants will be placed.

Key facts

Study ID

NCT03003819

Run by

McGuire Institute

People needed

64

Starts

2016-10-01

Expected to finish

2020-06-01

Last updated by the study team

2020-02-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject indicated for anterior tooth extraction (from premolars forward) intended for implant placement.
• Subjects with essentially intact extraction sockets - bony dehiscences < 1/3 the depth of socket and 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 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 collagen.
• Subjects with acute, suppurative lesions with pain, swelling and apical lesions > 5mm will be excluded, though antibiotic prophylaxis may be employed to reduce infection and provide possible subject reconsideration for inclusion.
• Heavy smokers/tobacco users defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day. For non-heavy smokers, smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day is prohibited for the duration of the study.
• 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.

Where it is running

• Seven Lakes Periodontics — Fenton, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.