CATER: Comprehensive Alveolar and Tooth Esthetic Replacement

NCT04082143 | Completed Phase 3 Results FDA Device

• 1 other identifier: 2019-0255
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Failure Nos

Outcome Measures

Primary Outcomes (1)

• Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning

  Volume of the alveolar ridge (percentage change of the volume) as measured by 3D Intraoral scanning

  12 months post implant surgery

Secondary Outcomes (3)

• Percentage of Implant Survival

  12 months post implant surgery

• Marginal Bone Levels (MBLs)

  12 months post implant surgery

• Vertical Tissue Change as Measured by 3D Intraoral Scanning

  12 months post surgery

Other Outcomes (1)

• Patient Satisfaction

  12 months post implant surgery

Study Arms (2)

Implant with prophylactic allograft

EXPERIMENTAL

Implant placement will be performed with simultaneous placement of the allograft.

Device: Allograft mucosal enhancement with dental implant

Implant without prophylactic allograft

ACTIVE COMPARATOR

Implant placement will be performed without a graft

Device: No allograft mucosal enhancement at time of dental implant placement

Interventions

Allograft mucosal enhancement with dental implant DEVICE

implant placement with allograft mucosal enhancement

Implant with prophylactic allograft

No allograft mucosal enhancement at time of dental implant placement DEVICE

implant placement without allograft mucosal enhancement

Implant without prophylactic allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (1)

University of Illinois at Chicago College of Dentistry

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Lyndon Cooper, Dean
• Organization: Virginia Commonwealth University

cooperlf@vcu.edu

(804) 828-7235

Study Officials

• Sandra Al-Tarawneh

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: subjects will be randomized to one of two groups

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: August 25, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 20, 2022
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)