Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
28 participants
INTERVENTIONAL
2023-05-26
2027-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Connective tissue graft
Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized
Vertical soft tissue augmentation
Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)
Dermal matrix + EMD
Acellular dermal matrix and enamel matrix derivative
Vertical soft tissue augmentation
Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)
Interventions
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Vertical soft tissue augmentation
Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)
Vertical soft tissue augmentation
Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)
Eligibility Criteria
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Inclusion Criteria
* Periodontally and systemically healthy
* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
* Presence of single functional dental implant in the anterior with a PSTD
* Implants diagnosed as healthy (Berglundh et al., 2018)
Exclusion Criteria
* Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing
* Patients pregnant or attempting to get pregnant (self-reported)
* Untreated periodontitis
* Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018)
* Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded
* History of soft tissue grafting at the implant site within the last 6 months
18 Years
99 Years
ALL
Yes
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
Responsible Party
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Lorenzo Tavelli
Assistant Professor
Principal Investigators
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Lorenzo Tavelli, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Dental Medicine, Boston, USA
Locations
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Harvard School of Dental Medicine
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ITI IMP (22-0600)
Identifier Type: -
Identifier Source: org_study_id
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