Insufficient width of keratinized gingiva
Conditions
Interventions
Group 1 (Pre-implantation or 6 months post bone augmentation):Submucosal injection of 150 µL hPBMC-EVs (derived from 20 mL of blood) at sites with insufficient keratinized gingiva. The total treatment
Group 2 (Post-implantation with open healing):Submucosal injection of 150 µL hPBMC-EVs (derived from 20 mL of blood) at sites with insufficient keratinized gingiva. The total treatment course consists
Group 3 (Post-prosthetic restoration):Submucosal injection of 150 µL hPBMC-EVs (derived from 20 mL of blood) at sites with insufficient keratinized gingiva. The total treatment course consists of 3 in
Sponsors
Affiliated Stomatology Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 65 years (inclusive), of any gender; (2) Physical examination reveals no clinically significant abnormal findings; laboratory tests including complete blood count, coagulation function, liver and kidney function, and preoperative infectious disease screening show no clinically significant abnormalities; (3) Diagnosed with insufficient keratinized gingiva width at the oral implant site, allocated into three groups based on different treatment phases in implant dentistry: Group (1): Pre-implantation or 6 months post bone augmentation, with keratinized gingiva width at the edentulous ridge crest < 4 mm (from buccal to lingual mucogingival junction); Group (2): Post-implantation with open healing, with labial/buccal site keratinized gingiva width < 2 mm; Group (3): After completion of implant prosthetic restoration, with labial/buccal site keratinized gingiva width < 2 mm; (4) No prior soft tissue defect reconstruction procedures have been performed at sites with inadequate keratinized gingiva width; (5) No oral mucosal lesions (e.g., lichen planus, pemphigus) present at sites with inadequate keratinized gingiva width; (6) Provide informed consent for participation in this study, accept injection therapy with peripheral blood mononuclear cell-derived apoptotic extracellular vesicles (hPBMC-EVs), and be willing and able to comply with all study-related procedures.
Exclusion criteria
Exclusion criteria: (1) In Group (2) and Group (3), individuals with insufficient labial/buccal keratinized gingiva due to improper implant size or three-dimensional positioning, or those with peri-implantitis; (2) Uncontrolled systemic diseases; or in the acute inflammatory phase or acute exacerbation phase of chronic diseases; (3) Current heavy smokers (>=10 cigarettes/day); (4) Pregnant or lactating women, or those planning pregnancy within six months; (5) Patients with hematologic disorders; (6) Patients with psychiatric or psychological disorders; (7) Patients who have previously undergone gingival/mucosal surgery in the surgical area; (8) Patients whom the investigator deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Keratinized Mucosa Width, KMW;Keratinized Mucosa Thickness, KMT;Complete Blood Count, CBC;Liver and Kidney Function Tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Plaque Index, mPLI;Modified Sulcus Bleeding Index, mBI;Probing Depth, PD;Marginal Bone Loss, MBL;Histologic outcomes;Patient-reported outcome measures, PROMs; | — |
Countries
China
Contacts
Public ContactShiyong Zhao
Affiliated Stomatology Hospital of Guangzhou Medical University
Outcome results
None listed