Recruiting

Socket Sealing Collagen

Sponsor:

McGuire Institute

Code:

NCT03003819

Conditions

Tooth Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Control Collagen Wound Dressing

Test Collagen Matrix

Study Details

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

Study ID

NCT03003819

Start date

Oct, 2016

Status verified date

Feb, 2020

Completion date

Jun, 2020

Anticipated

Primary completion date

Apr, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Collagen Wound Dressing

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

active comparator: Test Collagen Matrix

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

Interventions

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.

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.

Primary outcome measure

  • Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters [ Time Frame: 4-months ]

Central Contacts and Locations

Central contacts

Diego Velasquez, DDS, MSD

810.750.3500Periomichigan@gmail.com

Locations

Seven Lakes Periodontics

Recruiting

Fenton, Michigan, United States, 48430

Contacts

Diego Velasquez, DDS, MSD

810-750-3400Periomichigan@gmail.com

Principal Investigator:

Diego Velasquez, DDS, MSD

More Information

Sponsor

McGuire Institute

Last update posted

Feb 20, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGuire Institute on 2020-02-20.