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Geistlich Fibro-Gide® vs Connective Tissue Graft for Dental Implant Soft Tissue Enhancement
Study Summary
This trial compares the two methods for increasing soft tissue around dental implants and finds that Geistlich Fibro-Gide is non-inferior to the connective tissue graft.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I need soft tissue augmentation around a dental implant.I can maintain good oral hygiene around my implant and nearby teeth.I need soft tissue augmentation around an implant that has been in place for at least 6 months.I do not have any infections in the area where surgery is planned.My bone graft or implant has been in place for at least 6 months.You need to have at least 1 millimeter of a specific type of tissue called keratinized tissue width.I can keep my teeth and any implants very clean.My dental work was completed over 4 weeks ago.I have at least 1 mm of gum tissue around my teeth.My dental work has been finished for over 4 weeks.You have thin gums around your dental implant that may require additional soft tissue support.I do not have conditions like uncontrolled diabetes (A1C ≥7%), cancer, HIV, or severe gum disease that could affect healing.I am on medication that may affect wound healing.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using birth control.I have at least 1 mm of gum tissue around my teeth.My dental work has been finished for over 4 weeks.My bone graft or implant has been in place for at least 6 months.I have untreated gum disease that is not mild.I can maintain good oral hygiene, keeping my teeth and implants 80% plaque free.
- Group 1: Control
- Group 2: Test
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this investigation open to those over the age of 55?
"This experiment has an age-related criterion that states participants must be of legal adult age, but not over 80 years old."
Are there opportunities for enrolment in this trial currently?
"This research, which was initially posted to clinicaltrials.gov on August 13th 2018 and last revised December 14th 2021, is currently not looking for participants. However, there are other medical trials that are actively recruiting patients at this time."
How many centers are administering this experiment?
"This research is being administered at Perio Health Professionals in Houston, TX, Santarelli Oral and Facial Surgery in Kenosha, WI, Regenerative Solutions in Fullerton, CA as well five other medical facilities."
What population is eligible to partake in this research trial?
"This trial is seeking 60 individuals aged 18-80 with soft tissue deformations in need of augmentation. Candidates must be able to maintain 80% plaque free surfaces on their implant and adjacent teeth, have had an implant placed at least 6 months prior, display no recession around the body of said implant, and possess a minimum width of 1 mm keratinized tissue (KTw)."
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