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

NCT03003819 | Unknown

• 1 other identifier: GPNA0001-2016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Socket Soft Tissue Gap Closure - linear measures mesial-distal

  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

  4-months

• Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months

  4-months

Study Arms (2)

Control Collagen Wound Dressing

ACTIVE COMPARATOR

Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds

Device: Control Collagen Wound Dressing

Test Collagen Matrix

ACTIVE COMPARATOR

Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting

Device: Test Collagen Matrix

Interventions

Control Collagen Wound Dressing DEVICE

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.

Control Collagen Wound Dressing

Test Collagen Matrix DEVICE

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.

Test Collagen Matrix

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• McGuire Institute: lead

Study Sites (1)

Seven Lakes Periodontics

Fenton, Michigan, 48430, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 22145767 BACKGROUND

• 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.

  PMID: 15332186 BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Todd V Scantlebury, BS

  The McGuire Institute

  STUDY DIRECTOR

Central Study Contacts

Diego Velasquez, DDS, MSD

CONTACT

810.750.3500; Periomichigan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: December 28, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)