Clinical trial NCT06540690: Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
Official title: Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palate; Wound
Wound Heal
Diabetes
Keywords: Periodontology
Wound healing
Controlled Clinical Trial
Diabetes
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled clinical study, non-randomized, prospective, blinded, with a three-month follow-up.
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients, evaluate clinical, patient-centered and immunological parameters as well as wound microbiome composition.

Detailed description: The use of autogenous grafts from the palate for the reconstruction of gingival tissues is considered the gold standard for various periodontal and peri-implant reconstructions. Given the current aging of the population, it is essential to understand the cellular mechanisms responsible for the repair response in oral tissues and how they are affected by systemic diseases, such as diabetes mellitus (DM). The objectives of the present study, conducted through a controlled clinical trial, are to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients. This will be achieved through clinical analyses, patient-centered parameters, inflammatory biomarkers, and wound microbiome composition. To accomplish this, 50 patients will be divided into two groups: the Diabetic Group (D; n = 25), where diabetic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft, and the Control Group (GC; n = 25), where normoglycemic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft. The groups will be compared regarding clinical parameters, patient-centered measures, including remaining wound area, epithelialization, tissue thickness, immature wound area, tissue edema, early wound healing index, postoperative discomfort, quality of life, number of analgesics, and sensitivity of the operated area over a 3-month period. Furthermore, the wound biofilm will be described through microbiome analysis, and tissue, saliva, and wound exudate biomarkers will be characterized. Descriptive statistics will be expressed as mean ± standard deviation, clinical evaluations will be performed using repeated measures ANOVA, and patient-centered parameters will be assessed using the T-test. Finally, multiple linear regression and correlation tests will be employed.

Eligibility criteria: Inclusion Criteria:

* Patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (Ainamo, Bay, 1975);
* Patients with no morphological or pathological conditions on the palatine donor area;
* Patients who present indication for extraction and ridge preservation;
* The tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion;
* Patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).
* Patients diagnosed with type 2 diabetes for more than 5 years who are using oral hypoglycemic agents or insulin supplementation, with HbA1c levels ranging from ≥ 6.1% to 8.5%.
* Non-diabetic patients with HbA1c levels below 6.1%.

Exclusion Criteria:

* Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
* Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
* Smokers patients;
* Pregnant or lactating patients;
* Patients who had had periodontal surgery on the study area;
* Patients who presents opportunistic oral lesions, mainly colonized the palate region;
* Use of dental prosthesis with palatal cover;
* Thin palatal mucosa (\~2.0mm).

Primary outcomes:
measure: Open Wound Area (OWA)
timeFrame: baseline, 7, 14, 21 days after surgery
Secondary outcomes:
measure: Tissue Thickness (TT)
timeFrame: baseline, 90 days after surgery
measure: Epithelialization (E)
timeFrame: baseline, 7, 14, 21, 30 e 90 days after surgery
measure: Early wound healing index (EWHI)
timeFrame: 7 and 14 days after surgery
measure: Tissue Edema (TE)
timeFrame: 7 days
measure: Oral Health Impact Profile (OHIP)
timeFrame: 14 days
measure: Number of analgesics
timeFrame: 14 days
measure: Patient Discomfort
timeFrame: 14 days
measure: Qualitative somatosensory testing (QualST)
timeFrame: 7, 14 days
measure: Immunologic Analysis
timeFrame: baseline, 3, 7 days
measure: Microbiome Analysis
timeFrame: baseline, 7, 14, 21, 30 e 90 days after surgery
measure: Tissue Analysis
timeFrame: baseline
measure: Saliva Analysis
timeFrame: baseline, 7 days
Other outcomes:
Locations:
city: São José Dos Campos
country: Brazil
facility: Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe
state: Sao Paulo
city: Sao Jose dos Campos
country: Brazil
facility: College of Dentistry - São José dos Campos, Sao Paulo State University
state: SP
Study officials:
References:
citation: Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.
citation: Kamalathevan P, Ooi PS, Loo YL. Silk-Based Biomaterials in Cutaneous Wound Healing: A Systematic Review. Adv Skin Wound Care. 2018 Dec;31(12):565-573. doi: 10.1097/01.ASW.0000546233.35130.a9.
citation: Black S, Phillips D, Hickey JW, Kennedy-Darling J, Venkataraaman VG, Samusik N, Goltsev Y, Schurch CM, Nolan GP. CODEX multiplexed tissue imaging with DNA-conjugated antibodies. Nat Protoc. 2021 Aug;16(8):3802-3835. doi: 10.1038/s41596-021-00556-8. Epub 2021 Jul 2.
citation: Fickl S, Fischer KR, Jockel-Schneider Y, Stappert CF, Schlagenhauf U, Kebschull M. Early wound healing and patient morbidity after single-incision vs. trap-door graft harvesting from the palate--a clinical study. Clin Oral Investig. 2014 Dec;18(9):2213-9. doi: 10.1007/s00784-014-1204-7. Epub 2014 Feb 23.