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Autogenous Connective Tissue Graft

Geistlich Fibro-Gide® for Gum Recession

N/A
Waitlist Available
Led By Monica P Gibson, BDS,MS(Perio),PhD,FRCD(C)
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after surgery.
Awards & highlights

Study Summary

This trial will evaluate whether a biomaterial can be used to thicken gum tissue prior to orthodontic treatment, and if it can withstand the pressure of orthodontic movement.

Who is the study for?
This trial is for healthy teens aged 13-17 who need their upper jaw expanded and have thin gum tissue. They must have all permanent teeth, a crossbite or narrow maxilla, and at least one tooth with thin gums on certain teeth. Those with previous orthodontic treatment, compromised immune systems, smokers, pregnant or lactating females, active tooth decay or habits affecting the mouth are excluded.Check my eligibility
What is being tested?
The study tests if Geistlich Fibro-Gide®, a biomaterial substitute for gum grafts from the patient's palate can thicken gums before braces to prevent tissue loss during jaw expansion. It compares this new method to traditional surgery by assessing healing, satisfaction, pain levels and gum shape after treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the surgical site, swelling of treated areas in the mouth following surgery to modify gingival phenotype prior to orthodontic procedures. The severity of these side effects will be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after surgery. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gingival margin level in relation to the Cemento Enamel Junction CEJ
Keratinized Tissue Thickness
Keratinized Tissue Width
Secondary outcome measures
Duration of Surgery
Visual Analog Score for Discomfort
Visual Analog Score for Pain
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Test armExperimental Treatment1 Intervention
Geistlich Fibro-Gide ®.
Group II: ControlActive Control1 Intervention
Autogenous Connective Tissue Graft.

Find a Location

Who is running the clinical trial?

Geistlich Pharma AGIndustry Sponsor
41 Previous Clinical Trials
2,076 Total Patients Enrolled
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,778 Total Patients Enrolled
Monica P Gibson, BDS,MS(Perio),PhD,FRCD(C)Principal InvestigatorU of Alberta Co-Director,Perio Graduate Prog,Faculty of Medicine & Dentistry-Dentistry Dept

Media Library

Autogenous Connective Tissue Graft (Autogenous Connective Tissue Graft) Clinical Trial Eligibility Overview. Trial Name: NCT05295771 — N/A
Crossbite Research Study Groups: Control, Test arm
Crossbite Clinical Trial 2023: Autogenous Connective Tissue Graft Highlights & Side Effects. Trial Name: NCT05295771 — N/A
Autogenous Connective Tissue Graft (Autogenous Connective Tissue Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05295771 — N/A

Frequently Asked Questions

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

What key outcomes is this clinical trial hoping to achieve?

"Geistlich Pharma AG, the study sponsor, has outlined Keratinized Tissue Thickness as the primary outcome to be measured over a 24 week period after surgery. Moreover, they have identified secondary outcomes such as Duration of Surgery (from anesthesia to sutures), Visual Analog Score for Discomfort (to assess level of pain) and Wound Healing Index (Huang et al 2005)."

Answered by AI

How many test subjects are involved in this trial?

"Affirmative. Online records on clinicaltrials.gov demonstrate this medical study is actively seeking out applicants, with the initial post dating back to April 1st 2022 and last edited May 10th 2022. To date, 30 individuals are needed for the trial at one particular site."

Answered by AI

Are there any available opportunities for participants to join this trial?

"This research project is still recruiting participants, as indicated by clinicaltrials.gov records showing an initial post date of April 1st 2022 and a most recent update on May 10th 2022."

Answered by AI

Would I be eligible to join this research program?

"This clinical trial is accepting a total of 30 candidates that have crossbite and are within the age range of 13 to 17."

Answered by AI

Is the participation of minors permissible in this trial?

"With eligibility criteria of over 13 years old and below 17, this clinical trial is recruiting participants who fall within that age range."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.
2022. "Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05295771.
~0 spots leftby Apr 2025
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