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

A Prospective, Randomized, Controlled, Multi-center Evaluation of Extraction Socket Management Comparing Two Socket Sealing Collagen Matrices

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.

Study Overview

• Status: Unknown
• Conditions: Tooth Loss
• Intervention / Treatment: Device: Control Collagen Wound Dressing; Device: Test Collagen Matrix

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Fenton, Michigan, United States, 48430
      • Recruiting
      • Seven Lakes Periodontics
      • Contact: Diego Velasquez, DDS, MSD; Phone Number: 810-750-3400; Email: Periomichigan@gmail.com
      • Sub-Investigator: Rick Heard, DDS
      • Sub-Investigator: Jim Janakievski, DDS
      • Sub-Investigator: Marc Nevins, DDS
      • Sub-Investigator: Brian Pope, DDS
      • Sub-Investigator: Gregory Toback, DDS
      • Sub-Investigator: Chris Richardson, DMD
      • Principal Investigator: Diego Velasquez, DDS, MSD
      • Sub-Investigator: Don Clem, DDS
      • Sub-Investigator: Michael Pikos, DDS
      • Sub-Investigator: Pamela McClain, DDS
      • Sub-Investigator: Michael McGuire, DDS
      • Sub-Investigator: Craig Misch, DDS, MDS
      • Principal Investigator: Greg Santarelli, DDS
      • Sub-Investigator: Rachel Schallhorn, DDS, MS
      • Sub-Investigator: Eric T Scheyer, DDS, MS
      • Sub-Investigator: Stephen Pickering, DDS, MSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Collagen Wound Dressing; Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds	Device: Control Collagen Wound Dressing; 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.
Active Comparator: Test Collagen Matrix; Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting	Device: Test Collagen Matrix; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socket Soft Tissue Gap Closure - linear measures mesial-distal	Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.	4-months
Graft Containment as observed by subject and examiner (yes/ no)		4-months
Inflammation Score (Loe and Sillness)		4-months
Biomaterial Integrity - 4-point scale	Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue	4-months
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	4-months

Collaborators and Investigators

• Sponsor: McGuire Institute
• Investigators: Study Director: Todd V Scantlebury, BS, The McGuire Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: December 18, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: GPNA0001-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No