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Tooth LossNCT03003819

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

A study testing Test Collagen Matrix in people with Tooth Loss, run by McGuire Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Tooth Loss
What is being tested?
Test Collagen Matrix
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
Oct 2016to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Diego Velasquez, DDS, MSD contact

810.750.3500

Periomichigan@gmail.com

United States1 site, 1 recruiting

  • Seven Lakes Periodontics

    Fenton, Michigan, 48430

    Diego Velasquez, DDS, MSD, 810-750-3400, Periomichigan@gmail.com

    Rick Heard, DDS

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Tooth Loss
Being tested
Control Collagen Wound Dressing, Test Collagen Matrix
Medical subject headings
Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control Collagen Wound DressingDevice

    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 MatrixDevice

    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.

Study groups in NCT03003819
Study groupRoleWhat they receive
Control Collagen Wound DressingActive comparatorBovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds
Receives: Device: Control Collagen Wound Dressing
Test Collagen MatrixActive comparatorBilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting
Receives: Device: Test Collagen Matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4-months

Secondary outcomes (5)

  1. Socket Soft Tissue Gap Closure - linear measures mesial-distal

    Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.

    Measured: 4-months

  2. Graft Containment as observed by subject and examiner (yes/ no)

    Measured: 4-months

  3. Inflammation Score (Loe and Sillness)

    Measured: 4-months

  4. Biomaterial Integrity - 4-point scale

    Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue

    Measured: 4-months

  5. 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

    Measured: 4-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionApr 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003819
Sponsor's protocol ID
GPNA0001-2016
Status last verified
Feb 2020
First submitted
18 Dec 2016
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 22145767

  • 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.

    PubMed 15332186

Questions about this trial

What is this clinical trial studying?

A study testing Test Collagen Matrix in people with Tooth Loss, run by McGuire Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Diego Velasquez, DDS, MSD (810.750.3500, Periomichigan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters (time frame: 4-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03003819, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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