Dimensional Changes: Randomized Clinical Trial

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT05684068
Status
Not Yet Recruiting

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Conditions

  • Gingival Recession

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • Gum Graft Placed on Denuded Bone — PROCEDURE
    The provider will administer local anesthesia into the subject's gum in order to numb both the subject's donor and recipient areas for gum grafts. Next, the provider will use a surgical blade to dissect the gum graft from the subject's donor site. At the subject's recipient gum recession defect site, the provider will remove all of the subject's tissue, so that the bone is fully exposed before placing a gum graft from the donor site. Afterward, the provider will place sutures in the subject's recipient site in order to promote healing/re-growth.
  • Gum Graft Placed on Split Thickness Periosteal Bed Preparation — PROCEDURE
    The provider will administer local anesthesia into the subject's gum in order to numb both the subject's donor and recipient areas for gum grafts. Next, the provider will use a surgical blade to dissect the gum graft from the subject's donor site. At the subject's recipient gum recession defect site, the provider will dissect some of the tissue at the subject's recipient site but still keep a small layer of tissue at the subject's recipient site before placing a gum graft from the donor site. Afterward, the provider will place sutures in the subject's recipient site in order to promote healing/re-growth.

Study Details

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.

Key Dates

Start date
Aug 31, 2028
Status verified
Aug 2025
Primary completion
Jul 31, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gum Graft Placed on Denuded Bone
    Subjects in this arm 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).
  • Active Comparator: Gum Graft Placed on Split Thickness Periosteal Bed Preparation
    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).

Primary Outcome Measure

Change from Baseline in Gingival Thickness as assessed by measurement. [ Time Frame: Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa College of Dentistry and Dental ClinicsIowa CityIowa52242
Carlos Garaicoa Pazmino, DDS, MS
[email protected]
(319) 467-4315

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By research site
University of Iowa College of Dentistry and Dental Clinics· Iowa City, IA

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