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Trial record 1 of 17 for:    CATER
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CATER: Comprehensive Alveolar and Tooth Esthetic Replacement (CATER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082143
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Lyndon F Cooper, University of Illinois at Chicago

Brief Summary:

The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.

On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum graft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.

Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic at 1 year after implant placement for implant evaluation. At this final study appointment, x-rays and a 3D intraoral scan will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be assessed via bleeding upon probing and completion of a brief questionnaire, respectively.


Condition or disease Intervention/treatment Phase
Dental Implant Failure Nos Device: Allograft mucosal enhancement with dental implant Device: No allograft mucosal enhancement at time of dental implant placement Phase 3

Detailed Description:

An alveolar ridge is the part of the jawbone which immediately surrounds and anchors the tooth socket ("alveolus"). Similar to any bone or muscle atrophying when not used, the alveolar ridge will shrink ("resorb") following tooth extraction. The volume of an alveolar ridge can be measured by both 3 Dimensional ("3D") intraoral scan and radiography, and is used clinically as a metric of oral health.

A dental implant is a medical-grade titanium screw placed into healed alveolar bone or a tooth socket following tooth extraction. It replaces the tooth root and supports the crown, or "dental cap"; an artificial tooth generally made with porcelain or surgical grade metals.

Implant success requires both sufficient bone alveolar volume and sufficient mucosal tissue to protect against biofilm-mediated inflammation, assure functional comfort and contribute to dental implant esthetics. Following dental implant placement, the alveolar ridge resorbs approximately 0.5 to 1.0 mm during the first year. Healed ridges are also often volumetrically deficient, losing up to 30% of their horizontal volume following tooth extraction.

To remedy this, peri-implant mucosal grafting has been proposed and is currently part of dental implant therapy. Both autogenous grafts (mucosal connective tissue from the roof of the patient's own mouth or "palate") and allogeneic grafts (collagen-rich grafts derived from a genetically non-identical human donor) are used for these purposes, but there is controversy regarding the effectiveness of supplemental graft use during implant treatment.

The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.

On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum allograft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.

Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic about 1 year after implant placement for assessment of the implant evaluation. At this final study appointment, x-rays, a 3D intraoral scan and intraoral photographs of the implant will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be measured via bleeding upon probing and completion of a brief questionnaire, respectively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subjects will be randomized to one of two groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CATER: Comprehensive Alveolar and Tooth Esthetic Replacement
Actual Study Start Date : August 25, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Arm Intervention/treatment
Experimental: Implant with prophylactic allograft Device: Allograft mucosal enhancement with dental implant
implant placement with allograft mucosal enhancement

Active Comparator: Implant without prophylactic allograft Device: No allograft mucosal enhancement at time of dental implant placement
implant placement without allograft mucosal enhancement




Primary Outcome Measures :
  1. Volume of alveolar ridge [ Time Frame: 12 months post implant surgery ]
    Volume of the alveolar ridge (in millimeters) as measured by 3D Intraoral scanning


Secondary Outcome Measures :
  1. Implant survival [ Time Frame: 12 months post implant surgery ]
    Implant survival at 12 months post implant surgery

  2. Marginal Bone Levels (MBLs) [ Time Frame: 12 months post implant surgery ]
    Marginal bone levels (in millimeters) as measured by radiographic translucency

  3. Bleeding upon probing [ Time Frame: 12 months post implant surgery ]
    Bleeding upon probing in millimeters as measured by dental probe


Other Outcome Measures:
  1. Patient Satisfaction [ Time Frame: 12 months post implant surgery ]
    Patient satisfaction with implant therapy as measured by the Oral Health Impact Profile



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Willing and able to provide informed consent
  • In need of one implant to replace a missing tooth
  • At least 20 teeth in good repair and occlusion
  • Sufficient bone volume for dental implant placement without required bone augmentation
  • Site development (soft and/or bone tissue) performed at least 5 months before implant placement, when required

Exclusion Criteria:

  • Current smoker
  • Implant cannot be placed without bone graft
  • Unable to pay for crown
  • Untreated rampant caries and/or uncontrolled periodontitis
  • Absence of adjacent (mesial and/or distal) natural tooth
  • Uncontrolled diabetes
  • Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • use of bisphosphonates
  • History of radiation in the head and neck region
  • Unable or unwilling to return for follow-up visits
  • Unrealistic esthetic or functional demands
  • Unlikely to be able to comply with study procedures
  • Unwilling or unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082143


Contacts
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Contact: Susan Ferguson, MS (312) 996-7226 DentCRC@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago College of Dentistry Recruiting
Chicago, Illinois, United States, 60611
Contact: Susan Ferguson, MS    312-996-7226    DentCRC@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Dentsply Sirona Implants
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Responsible Party: Lyndon F Cooper, Associate Dean of Research, Chair-Dept. of Oral Biology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04082143    
Other Study ID Numbers: 2019-0255
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No