Clinical trial NCT03003819: A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management
Official title: A Prospective, Randomized, Controlled, Multi-center Evaluation of Extraction Socket Management Comparing Two Socket Sealing Collagen Matrices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters
timeFrame: 4-months
Secondary outcomes:
measure: Socket Soft Tissue Gap Closure - linear measures mesial-distal
timeFrame: 4-months
measure: Graft Containment as observed by subject and examiner (yes/ no)
timeFrame: 4-months
measure: Inflammation Score (Loe and Sillness)
timeFrame: 4-months
measure: Biomaterial Integrity - 4-point scale
timeFrame: 4-months
measure: Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months
timeFrame: 4-months
Other outcomes:
Locations:
city: Fenton
country: United States
facility: Seven Lakes Periodontics
state: Michigan
Study officials:
affiliation: The McGuire Institute
name: Todd V Scantlebury, BS
role: STUDY_DIRECTOR
References:
citation: Thoma DS, Sancho-Puchades M, Ettlin DA, Hammerle CH, Jung RE. Impact of a collagen matrix on early healing, aesthetics and patient morbidity in oral mucosal wounds - a randomized study in humans. J Clin Periodontol. 2012 Feb;39(2):157-65. doi: 10.1111/j.1600-051X.2011.01823.x. Epub 2011 Dec 6.
citation: Sclar AG. Strategies for management of single-tooth extraction sites in aesthetic implant therapy. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):90-105. doi: 10.1016/j.joms.2004.06.041.