To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratin… (NCT03338686) | Clinical Trial Compass
CompletedNot Applicable
To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
United States14 participantsStarted 2016-01-07
Plain-language summary
This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa.
To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
Who can participate
Age range
18 Years – 99 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
. English speaking
. At least 18 years old
. Must be a patient of the UAB Dental School, able to read and understand informed consent document
. One or more adjacent dental implants having \<2mm in width of keratinized mucosa or attached mucosa \<1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type
. No crestal bone loss or minimal bone resorption not extending apical to first implant thread
. Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s)
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
The Increase in Keratinized Mucosa (in mm) Between the Two Grafts
. Implants requiring soft tissue grafting after placement (\>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration
Exclusion criteria
. Non-English speaking
. Less than 18 years old
. Smokers/tobacco users (\>10 cigarettes/day)
. Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
. Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
. Presence of soft tissue recession exposing threads at implant site
. Presence of bony dehiscence at implant site (s)\_ at time of surgery
. Previous soft tissue grafting at the implant site (s)