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.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Gingival Thickness as assessed by measurement.