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Procedure

Buccal Graft + Collagen Matrix vs. Free Gingival Graft for Dental Surgery (FGGvsBSG+CM Trial)

N/A
Recruiting
Led By Lorenzo Tavelli, DDS, MS, PhD
Research Sponsored by Harvard Medical School (HMS and HSDM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months
Awards & highlights

FGGvsBSG+CM Trial Summary

This trial compares two methods of tissue grafting at dental implants to improve gum width and adherence.

Who is the study for?
This trial is for adults over 18 who are healthy both in their gums and overall health, with good oral hygiene. They must have at least one dental implant needing more gum tissue around it and enough healthy gum on other teeth to provide graft material.Check my eligibility
What is being tested?
The study compares two methods of increasing the amount of tough skin-like tissue around dental implants: a traditional free gingival graft (FGG) versus a buccal strip graft combined with a collagen matrix (BSG + CM).See study design
What are the potential side effects?
Possible side effects may include discomfort, swelling, bleeding at the site of surgery or donor site, infection risk, and potential failure of the graft to integrate properly.

FGGvsBSG+CM Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sites showing KM≥ 2 mm and AM≥ 1 mm
Secondary outcome measures
AM gain
Esthetic assessment
KM width gain
+6 more

FGGvsBSG+CM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Buccal Strip Graft + Collagen matrix (bSG + CM)Experimental Treatment1 Intervention
Strip graft obtained from the buccal mucosa of a site showing abundant keratinized gingiva, combined with a collagen matrix. The bSG + CM graft is stabilized/sutured to the recipient site (implant).
Group II: Free gingival graft (FGG)Active Control1 Intervention
Conventional free gingival graft, involving the harvesting of an epithelialized graft from the hard palate, which is then stabilized/sutured to the recipient site (implant).

Find a Location

Who is running the clinical trial?

Harvard Medical School (HMS and HSDM)Lead Sponsor
195 Previous Clinical Trials
1,316,013 Total Patients Enrolled
1 Trials studying Surgery
400 Patients Enrolled for Surgery
Osteology FoundationOTHER
11 Previous Clinical Trials
522 Total Patients Enrolled
Lorenzo Tavelli, DDS, MS, PhDPrincipal InvestigatorHarvard School of Dental Medicine, Boston, USA

Media Library

Buccal Strip Graft with a collagen matrix (bSG + CM) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05844475 — N/A
Surgery Research Study Groups: Free gingival graft (FGG), Buccal Strip Graft + Collagen matrix (bSG + CM)
Surgery Clinical Trial 2023: Buccal Strip Graft with a collagen matrix (bSG + CM) Highlights & Side Effects. Trial Name: NCT05844475 — N/A
Buccal Strip Graft with a collagen matrix (bSG + CM) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844475 — N/A

Frequently Asked Questions

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

Does the research initiative currently accept new participants?

"Per the clinicaltrials.gov listing, this medical trial is still recruiting participants. It was first posted on April 13th 2023 and was most recently edited a few weeks later on April 25th."

Answered by AI

How many participants have been included in the evaluation of this experiment?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this research is actively looking for volunteers. The trial was initially published on April 13th 2023 and has been most recently edited as of April 25th 2023. This particular study requires 32 individuals from 1 medical centre to participate."

Answered by AI

Who else is applying?

What site did they apply to?
Harvard School of Dental Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I want dental implants.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites
Lorenzo Tavelli 2023. "Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844475.
~19 spots leftby Dec 2025
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