RecruitingNot ApplicableNCT06294587

Evaluation of Free Gingival Graft Timing

Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial


Sponsor

University of Alabama at Birmingham

Enrollment

30 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • • 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 Criteria12

  • 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

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Interventions

PROCEDUREFGG Before GBR

Free Gingival Graft before the guided bone regeneration,

PROCEDUREFGG after GBR

Free Gingival Graft after the guided bone regeneration,


Locations(1)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, United States

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NCT06294587


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