Dimensional Changes: Randomized Clinical Trial
ConditionGingival Recession
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Gum Graft Placed on Denuded Bone
Procedure/SurgeryThe 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/SurgeryThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Gum Graft Placed on Denuded BoneExperimental treatment 1 intervention
Group B: Gum Graft Placed on Split Thickness Periosteal Bed PreparationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Gingival Thickness as assessed by measurement.
Tissue changes will be assessed in millimeters and percentage.
Time frame
Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: