CATER: Comprehensive Alveolar and Tooth Esthetic Replacement

Phase 3

Completed

Conditions: Dental Implant Failure Nos

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

Registration Number: NCT04082143

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implant with prophylactic allograft	Allograft mucosal enhancement with dental implant	-
Implant without prophylactic allograft	No allograft mucosal enhancement at time of dental implant placement	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning	12 months post implant surgery	Volume of the alveolar ridge (percentage change of the volume) as measured by 3D Intraoral scanning

Secondary Outcome Measures

Name	Time	Method
Percentage of Implant Survival	12 months post implant surgery	Implant survival at 12 months post implant surgery. Percentage of implants surviving after 12 months of placement
Marginal Bone Levels (MBLs)	12 months post implant surgery	Marginal bone levels (in millimeters) as measured by radiographic translucency. Bone levels between implant/abutment interface and crest of the bone were measured at time of implant placement and at 12 months later. The negative sign in the results below indicates that there was bone loss in both groups.
Vertical Tissue Change as Measured by 3D Intraoral Scanning	12 months post surgery	This measurement is for the vertical position of the gingival margin change based on superimposed 3D intraoral scans