Dimensional Changes: Randomized Clinical Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorUniversity of Iowa

About this trial

The goal of this clinical trial is to evaluate the dimensional changes in the short and long-term in patients with thin gum tissues who have gum grafts placed on either denuded bone or gum grafts placed on a bone with some tissues remaining.

The main question this study aims to answer is:

\- Does the placement of free-epithelized gingival grafts (gum grafts) on full thickness bed preparation (having all of the tissue removed from the bone) lead to similar clinical, digital, and patient-related outcomes and measurements over a period of 12 months versus split thickness bed preparation (where a small layer of tissue is left over the bone) in patients with thin gum tissue phenotypes (gum tissue is generally less than 1.5 millimeters) who are in need of soft tissue augmentation procedures?

Participants will be asked to attend 8 visits, which include: (i) screening visit, (ii) prophylaxis visit, (iii) random assignment to Group A or Group B along with surgery and digital data collection, (iv) 2-week post-operative visit, (v) 6-week post-operative visit, (vi) 3-month follow-up visit, (vii) 6-month follow-up visit, (viii) 12-month follow-up visit. Also, Group A will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). Group B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). Researchers will compare Group A and Group B to see if there is a difference in clinical, digital, and patient-related outcomes and measurements over a period of 12 months.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gum Graft Placed on Denuded Bone
  • Gum Graft Placed on Split Thickness Periosteal Bed Preparation

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators