CATER: Comprehensive Alveolar and Tooth Esthetic Replacement
United States39 participantsStarted 2019-08-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning