Clinical trial NCT05684068: Dimensional Changes: Randomized Clinical Trial
Official title: Dimensional Changes of Autogenous Free Epithelialized Gingival Grafts on Different Bed Preparations Among Dental Patients with Thin Tissue Phenotypes: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in Gingival Thickness as assessed by measurement.
timeFrame: Multiple time points (i.e., Baseline, 3 months, 6 months, 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry and Dental Clinics
state: Iowa
Study officials:
affiliation: University of Iowa College of Dentistry
name: Carlos Garaicoa, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: