Gum Graft Procedures for Thin Gum Tissues

This study is looking at two different ways to perform gum grafts for people with thin gum tissues (gingival recession). Researchers want to see if placing a gum graft on "denuded bone" (where all tissue is removed from the bone) leads to similar results as placing it on a "split thickness periosteal bed preparation" (where a small layer of tissue is left over the bone). The main goal is to measure changes in gum thickness over 12 months. You might be able to join if you are 18-95 years old, have inactive gum disease, and thin gum tissue. The current recruitment status is unclear.

Study design
This is a randomized clinical trial planning to enroll 50 participants. It compares two different gum graft procedures.
What's involved
You would receive local anesthesia and undergo a gum graft procedure. Your gum thickness will be measured at baseline, 3, 6, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your gum thickness will be measured for up to 12 months after the procedure.

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NCT05684068

Dimensional Changes: Randomized Clinical Trial

Not Yet Recruiting
NAAges 18–95InterventionalTreatment
University of Iowa
~50 participants
Updated 2025-08-19 on ClinicalTrials.gov
What's tested:Gum Graft Placed on Denuded BoneGum Graft Placed on Split Thickness Periosteal Bed Preparation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Gingival Thickness as assessed by measurement.
Measured over Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months)
Gingival Recession
1 sites across 1 states
Iowa1
  • Carlos Garaicoa, DDS, MS · PRINCIPAL_INVESTIGATOR · University of Iowa College of Dentistry

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Eligibility criteria

Inclusion

Patients 18-95 years of age
Inactive periodontal disease
Lack of, or an insufficient (less than 2 millimeters) band of keratinized tissue width on the buccal site (closest to the cheek)
Shallow vestibule depth (the space between the soft tissue (lips and cheeks), and the teeth and gums)
Thin gingival phenotype (less than 1.5mm of gum tissue depth).
Aberrant frenum attachment in need of free-epithelized gingival grafts.
At least one RT1, 2, or 3 (Cairo's classification) gingival recession defect on the mandibular anterior sextant (Teeth #22-27).
Non-smokers or past smokers (those who have stopped at minimum 6 months ago).
Patient willing and able to follow instruction related to the study procedures.

Exclusion

Previous soft tissue augmentation procedures at the area of interest.
Current smokers (Light smokers meaning less than 10 cigarettes/day, heavy smokers meaning more than 10 cigarettes/day, or social smokers)
Uncontrolled systemic disease (uncontrolled diabetes defined by blood sugar HbA1c greater than 7%)
Any active local or systemic infections
Any diseases or medications that may compromise normal wound healing
Currently receiving chemotherapy or radiotherapy or a history of radiotherapy in head and neck area.
Severe hematologic (blood) disorders
Pregnancy or nursing mother
Patients undergoing orthodontic therapy
Patients taking antibiotics in the past 3 months
  • Change from Baseline in Gingival Thickness as assessed by measurement.Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months)

    Tissue changes will be assessed in millimeters and percentage.