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Biomaterial
Collagen Matrix + Growth Factor for Implant Complications
N/A
Recruiting
Led By Lorenzo Tavelli, DDS, MS
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 3, 6 and 12 months
Awards & highlights
Study Summary
This trial compares two methods for treating issues around dental implants, CTG or a collagen matrix+growth factor.
Who is the study for?
This trial is for adults over 18 who have good oral hygiene and are in general good health. They should have a single dental implant in the front of their mouth with peri-implant soft tissue dehiscences, which they want to treat.Check my eligibility
What is being tested?
The study compares two treatments for aesthetic issues around dental implants: one uses a collagen matrix with growth factor (rhPDGF-BB), and the other uses tissue from the patient's own body.See study design
What are the potential side effects?
Potential side effects may include discomfort at the graft site, swelling, infection risk, and possible allergic reactions to collagen or rhPDGF-BB.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Soft tissue dehiscence reduction
Secondary outcome measures
3D Volumetric changes
Complete peri-implant soft tissue dehiscence (PSTD) coverage
Mucosal thickness changes
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Collagen matrix + rhPDGF-BBExperimental Treatment1 Intervention
Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB
Group II: Connective tissue graftActive Control1 Intervention
Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized
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Who is running the clinical trial?
Harvard Medical School (HMS and HSDM)Lead Sponsor
195 Previous Clinical Trials
1,316,017 Total Patients Enrolled
1 Trials studying Implant Complication
28 Patients Enrolled for Implant Complication
Lorenzo Tavelli, DDS, MSPrincipal InvestigatorHarvard School of Dental Medicine, Boston, USA
2 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Implant Complication
28 Patients Enrolled for Implant Complication
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I had soft tissue grafting at the implant site with problems in the last 6 months.I cannot undergo surgery due to health risks.My gums and overall health are good.I can take care of my teeth and mouth properly.I have untreated gum disease.I have untreated gum disease around my dental implant.I have a condition like diabetes or HIV that could affect wound healing.
Research Study Groups:
This trial has the following groups:- Group 1: Connective tissue graft
- Group 2: Collagen matrix + rhPDGF-BB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for this clinical trial?
"According to the clinicaltrials.gov website, this research trial is actively seeking participants and has not been altered since its initial posting on April 1st 2023."
Answered by AI
How many participants is the clinical trial limited to?
"Affirmative. Clinicaltrials.gov contains information affirming that this clinical trial is actively seeking patients, having been first posted on January 4th 2023 and last amended the same day. The aim of the study is to recruit 28 participants from a single location."
Answered by AI
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