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Soft Tissue Replacement

Geistlich Fibro-Gide® vs Connective Tissue Graft for Dental Implant Soft Tissue Enhancement

N/A
Waitlist Available
Led By Donald S Clem III, DDS
Research Sponsored by Geistlich Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who, can achieve good oral hygiene (80% plaque free surfaces on the implant and maintain 80% plaque free surfaces on teeth adjacent to treatment sites).
All implants must be at least 6 months post bone graft/implant placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2,4,12 weeks, 6 months, 1,3,5 years
Awards & highlights

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.

Who is the study for?
This trial is for individuals with good oral hygiene needing soft tissue augmentation around dental implants that have been in place for at least 6 months. Participants should not be on medications affecting wound healing, have untreated severe gum disease, uncontrolled diabetes, or a history of frequent nicotine use.Check my eligibility
What is being tested?
The study compares Geistlich Fibro-Gide®, an alternative to connective tissue grafts (CTG), for increasing soft tissue volume around dental implants. It's a double-blind test where patients are randomly assigned to receive either the new material or traditional CTG.See study design
What are the potential side effects?
While specific side effects aren't listed, typical risks may include swelling, discomfort at the implant site, bleeding, infection risk post-surgery and potential allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can maintain good oral hygiene around my implant and nearby teeth.
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My bone graft or implant has been in place for at least 6 months.
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I can keep my teeth and any implants very clean.
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I have at least 1 mm of gum tissue around my teeth.
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My dental work has been finished for over 4 weeks.
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I have at least 1 mm of gum tissue around my teeth.
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I can maintain good oral hygiene, keeping my teeth and implants 80% plaque free.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2,4,12 weeks, 6 months, 1,3,5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2,4,12 weeks, 6 months, 1,3,5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in gingival soft tissue volume assessed with 3D scanning
Secondary outcome measures
All Adverse Events, serious and non serious
Change in gingival soft tissue contour
Concomitant medication
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TestExperimental Treatment1 Intervention
Soft tissue flap + Geistlich Fibro-Gide®
Group II: ControlActive Control1 Intervention
Soft tissue flap + Connective Tissue Graft

Find a Location

Who is running the clinical trial?

Medelis Inc.Industry Sponsor
6 Previous Clinical Trials
446 Total Patients Enrolled
Geistlich Pharma AGLead Sponsor
41 Previous Clinical Trials
2,126 Total Patients Enrolled
Donald S Clem III, DDSPrincipal InvestigatorRegenative Solutions

Media Library

Soft tissue flap + Connective Tissue Graft (Soft Tissue Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04703738 — N/A
Soft Tissue Injury Research Study Groups: Control, Test
Soft Tissue Injury Clinical Trial 2023: Soft tissue flap + Connective Tissue Graft Highlights & Side Effects. Trial Name: NCT04703738 — N/A
Soft tissue flap + Connective Tissue Graft (Soft Tissue Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04703738 — N/A
Soft Tissue Injury Patient Testimony for trial: Trial Name: NCT04703738 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New Jersey
Virginia
Other
How old are they?
65+
18 - 65
What site did they apply to?
Perio Health Professionals
Periodontal and Dental Implant Surgical Specialist
Regenerative Solutions
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m tired of being unhappy with the condition of my mouth and being uncomfortable with dentures that no longer fit and prevent me from eating properly.
PatientReceived 2+ prior treatments
~9 spots leftby Mar 2025