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Tissue Matrix
Soft Tissue Augmentation 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 2 ways to increase soft tissue around dental implants: using body tissue vs. artificial material with a special protein.
Who is the study for?
This trial is for adults over 18 with a single functional dental implant in the front of their mouth that needs more gum tissue. They must have good oral hygiene and overall health, with no untreated gum disease around the implant. Smokers or those with certain systemic conditions like diabetes or cancer are excluded.Check my eligibility
What is being tested?
The study compares two methods for adding gum tissue to dental implants where there's not enough: using the patient's own tissue (CTG) versus a combination of donor skin matrix (ADM) and enamel matrix derivative.See study design
What are the potential side effects?
Possible side effects may include discomfort, swelling, bleeding at the graft site, infection risk, and potential rejection or failure of the graft material.
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
Change in Soft tissue dehiscence depth
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: Dermal matrix + EMDExperimental Treatment1 Intervention
Acellular dermal matrix and enamel matrix derivative
Group II: Connective tissue graftActive Control1 Intervention
Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized
Find a Location
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 have untreated gum disease around my dental implant.I have untreated gum disease.I am 18 years old or older.I have a condition like diabetes or HIV that could affect wound healing.I cannot undergo surgery due to health risks.I have had soft tissue grafting at the implant site in the last 6 months.I have healthy gums and no serious health issues.I have one working dental implant in the front with a PSTD.
Research Study Groups:
This trial has the following groups:- Group 1: Dermal matrix + EMD
- Group 2: Connective tissue graft
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.
Does my profile conform to the requirements for participating in this medical experiment?
"This clinical trial has stringent inclusion criteria, which necessitates that applicants have an implant complication and are between 18 to 99 years old. At this time, the study is looking for 28 participants."
Answered by AI
Is enrollment open to persons aged 55 or older for this trial?
"Individuals aged 18 to 99 may apply for this clinical trial. Specifically, there are 1 trials specifically designed for minors and 3 tailored towards those over 65 years old."
Answered by AI
Is there still an opportunity for participants to enrol in this research trial?
"In accordance with clinicaltrials.gov, this trial is not presently recruiting patients; it was first posted on March 1st 2023 and last edited February 14th 2023. However, there are 4 other studies that are proactively seeking participants at the present moment."
Answered by AI
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