A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management
Primary Purpose
Tooth Loss
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Collagen Wound Dressing
Test Collagen Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss
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.
Sites / Locations
- Seven Lakes PeriodonticsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control Collagen Wound Dressing
Test Collagen Matrix
Arm Description
Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds
Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting
Outcomes
Primary Outcome Measures
Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters
Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months.
Secondary Outcome Measures
Socket Soft Tissue Gap Closure - linear measures mesial-distal
Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.
Graft Containment as observed by subject and examiner (yes/ no)
Inflammation Score (Loe and Sillness)
Biomaterial Integrity - 4-point scale
Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue
Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03003819
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGuire Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Collagen Wound Dressing
Arm Type
Active Comparator
Arm Description
Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds
Arm Title
Test Collagen Matrix
Arm Type
Active Comparator
Arm Description
Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting
Intervention Type
Device
Intervention Name(s)
Control Collagen Wound Dressing
Intervention Description
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
Intervention Type
Device
Intervention Name(s)
Test Collagen Matrix
Intervention Description
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
Primary Outcome Measure Information:
Title
Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters
Description
Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months.
Time Frame
4-months
Secondary Outcome Measure Information:
Title
Socket Soft Tissue Gap Closure - linear measures mesial-distal
Description
Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.
Time Frame
4-months
Title
Graft Containment as observed by subject and examiner (yes/ no)
Time Frame
4-months
Title
Inflammation Score (Loe and Sillness)
Time Frame
4-months
Title
Biomaterial Integrity - 4-point scale
Description
Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue
Time Frame
4-months
Title
Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months
Description
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
Time Frame
4-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Velasquez, DDS, MSD
Phone
810.750.3500
Email
Periomichigan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd V Scantlebury, BS
Organizational Affiliation
The McGuire Institute
Official's Role
Study Director
Facility Information:
Facility Name
Seven Lakes Periodontics
City
Fenton
State/Province
Michigan
ZIP/Postal Code
48430
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Velasquez, DDS, MSD
Phone
810-750-3400
Email
Periomichigan@gmail.com
First Name & Middle Initial & Last Name & Degree
Rick Heard, DDS
First Name & Middle Initial & Last Name & Degree
Jim Janakievski, DDS
First Name & Middle Initial & Last Name & Degree
Marc Nevins, DDS
First Name & Middle Initial & Last Name & Degree
Brian Pope, DDS
First Name & Middle Initial & Last Name & Degree
Gregory Toback, DDS
First Name & Middle Initial & Last Name & Degree
Chris Richardson, DMD
First Name & Middle Initial & Last Name & Degree
Diego Velasquez, DDS, MSD
First Name & Middle Initial & Last Name & Degree
Don Clem, DDS
First Name & Middle Initial & Last Name & Degree
Michael Pikos, DDS
First Name & Middle Initial & Last Name & Degree
Pamela McClain, DDS
First Name & Middle Initial & Last Name & Degree
Michael McGuire, DDS
First Name & Middle Initial & Last Name & Degree
Craig Misch, DDS, MDS
First Name & Middle Initial & Last Name & Degree
Greg Santarelli, DDS
First Name & Middle Initial & Last Name & Degree
Rachel Schallhorn, DDS, MS
First Name & Middle Initial & Last Name & Degree
Eric T Scheyer, DDS, MS
First Name & Middle Initial & Last Name & Degree
Stephen Pickering, DDS, MSD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22145767
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.
Results Reference
background
PubMed Identifier
15332186
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. Erratum In: J Oral Maxillofac Surg. 2005 Jan;63(1):158.
Results Reference
background
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A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management
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