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Biomaterial

Prosthetic-surgical approach + graft substitute for Implant Complication

Harvard School of Dental Medicine, Boston, MA

Prosthetic-surgical approach + graft substitute +1 moreN/ARecruitingLed by Lorenzo Tavelli, DDS, MSResearch 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

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 below

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You are 18 years old or older.

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You are able to take care of your teeth and gums by brushing and flossing regularly.

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You do not have any gum disease or other health problems that could affect your participation in the study.

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 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

Soft tissue dehiscence reduction

Secondary outcome measures

3D Volumetric changes

Complete peri-implant soft tissue dehiscence (PSTD) coverage

Mucosal thickness changes

+3 more

Awards & 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

0 / 5Eligibility criteria met

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

Media Library

Collagen Matrix (Biomaterial) Clinical Trial Eligibility Overview. Trial Name: NCT05576922 — N/A

Implant Complication Research Study Groups: Connective tissue graft, Collagen matrix + rhPDGF-BB

Implant Complication Clinical Trial 2023: Collagen Matrix Highlights & Side Effects. Trial Name: NCT05576922 — N/A

Collagen Matrix (Biomaterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05576922 — N/A

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

Recent research and studies

clinicaltrials.govStudy

Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences

Lorenzo Tavelli 2023. "Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05576922.