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

Not Applicable

• Conditions: Tooth Loss
• Interventions: Device: Control Collagen Wound Dressing; Device: Test Collagen Matrix

• Registration Number: NCT03003819
• Lead Sponsor: McGuire Institute

Brief Summary

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.

Detailed Description

A prospective, randomized, multi-center, controlled clinical study of intact extractions (bony dehiscences \<1/3 socket apico-coronal and mesial-distal dimension) with delayed implant placement. Study objective: to compare extraction socket management effectiveness and office economics of a frequently used wound dressing (control) with a soft tissue augmentation matrix (test) in 32-64 subjects 18 -75 years of age with intact (bony dehiscence, if present, \< 1/3 socket dimension) extractions intended for dental implant replacement. Following screening subjects will undergo tooth extraction and randomization to either the control or test therapy. After treatment, subjects will be followed until 4- months, the time of implant placement. Primary outcome: soft tissue wound healing measured by (1) gap closure and (2) graft containment at all time points.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-18
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-04
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Collagen Wound Dressing	Control Collagen Wound Dressing	Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds
Test Collagen Matrix	Test Collagen Matrix	Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting

Primary Outcome Measures

Name	Time	Method
Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters	4-months	Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months.

Secondary Outcome Measures

Name	Time	Method
Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months	4-months	Soft tissue thickness is measured using probe "show-thru" (tissue transparency) at baseline and soft tissue biopsy at the implant site immediately prior to implant placement
Socket Soft Tissue Gap Closure - linear measures mesial-distal	4-months	Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.
Inflammation Score (Loe and Sillness)	4-months
Graft Containment as observed by subject and examiner (yes/ no)	4-months
Biomaterial Integrity - 4-point scale	4-months	Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue

Trial Locations

Locations (1)

Seven Lakes Periodontics; 🇺🇸 Fenton, Michigan, United States