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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Ability to perform good oral hygiene
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3, 6 and 12 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial compares two methods for treating issues around dental implants, CTG or a collagen matrix+growth factor.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are 18 years old or older.
Select...
You are able to take care of your teeth and gums by brushing and flossing regularly.
Select...
You do not have any gum disease or other health problems that could affect your participation in the study.
Select...
You have a dental implant in the front part of your mouth that has a problem, and your overall oral health is good with low levels of plaque and bleeding during dental exams.
Select...
Your dental implants must be healthy and have flat gums around them.
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
Find a Location
Who is running the clinical trial?
Harvard Medical School (HMS and HSDM)Lead Sponsor
189 Previous Clinical Trials
1,316,345 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older.You are able to take care of your teeth and gums by brushing and flossing regularly.Your dental implants must be healthy and have flat gums around them.You do not have any gum disease or other health problems that could affect your participation in the study.You have a dental implant in the front part of your mouth that has a problem, and your overall oral health is good with low levels of plaque and bleeding during dental exams.
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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