Alveolar Mucosa, Ridge Augmentation
Conditions
Keywords
Ridge Augmentation, Attached mucosa, Dental implants
Brief summary
This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.
Detailed description
This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft. The primary objective is to assess the influence of the tissue graft timing on the outcomes of the guided bone regeneration. The secondary goal is to compare the complications that may arise following the two procedures before implant placement.
Interventions
PROCEDUREFGG Before GBR
Free Gingival Graft before the guided bone regeneration,
PROCEDUREFGG after GBR
Free Gingival Graft after the guided bone regeneration,
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • At least 18 years old * 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
* Active infectious diseases. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric outcome assessment | Baseline to 12 months | The volumetric outcomes of interest will be volume change in mm3 (Vol) and the mean distance between the surface/mean thickness of the reconstructed volume in mm. |
| Buccal soft tissue profile | Baseline to 12 months | The assessment involves measuring the profile of the buccal soft tissue from the implant shoulder. |
Countries
United States
Contacts
CONTACTHussein Basma, DDS, MS
CONTACTSarah Startley, DMD
Outcome results
None listed