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
30 participants
INTERVENTIONAL
2024-08-12
2027-08-30
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
NONE
Study Groups
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FGG before GBR
Free Gingival Graft(FGG) before the guided bone regeneration(GBR)
FGG Before GBR
Free Gingival Graft before the guided bone regeneration,
FGG after GBR
Free Gingival Graft(FGG) after the guided bone regeneration(GBR)
FGG after GBR
Free Gingival Graft after the guided bone regeneration,
Interventions
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FGG Before GBR
Free Gingival Graft before the guided bone regeneration,
FGG after GBR
Free Gingival Graft after the guided bone regeneration,
Eligibility Criteria
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Inclusion Criteria
* No uncontrolled medical conditions or medications that will affect their bone healing.
* Good oral hygiene is defined as a full-mouth plaque score ≤25%11.
* Must be able to read and understand the informed consent document.
* Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth.
* Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan.
* The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required.
* The patient is not pregnant or breastfeeding.
Exclusion Criteria
* Liver or kidney dysfunction/failure.
* Uncontrolled diabetes (HbA1c ≥ 8.5).
* Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure.
* Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications).
* Metabolic bone diseases that affect bone healing such as osteoporosis.
* Pregnant or lactating women (self-reported).
* Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (\> 10 cigarettes) who quit \< 10 ago (self-reported).
* Poor oral hygiene.
* Vertical loss of bone at the edentulous ridge.
* History of periodontal disease.
* The patient is pregnant or breastfeeding
18 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Hussein Basma
Clinical Assistant Professor, Principal Investigator
Locations
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Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 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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UAB-SOD
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-300012407
Identifier Type: -
Identifier Source: org_study_id
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