Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients

NCT06540690 | Recruiting

• 1 other identifier: UEPJMF 14
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Palate; Wound; Wound Heal; Diabetes

Keywords

Periodontology; Wound healing; Controlled Clinical Trial; Diabetes

Outcome Measures

Primary Outcomes (1)

• Open Wound Area (OWA)

  For this, standardized photographs will be taken. As a reference, a scale will be used to measure this area. These photographs will be exported to image software (Image J - National Institute of Health -NIH, Bethesda, USA), the area of the wound will be measured in square millimeters (Dias et al. 2015)

  baseline, 7, 14, 21 days after surgery

Secondary Outcomes (12)

• Tissue Thickness (TT)

  baseline, 90 days after surgery

• Epithelialization (E)

  baseline, 7, 14, 21, 30 e 90 days after surgery

• Early wound healing index (EWHI)

  7 and 14 days after surgery

• Tissue Edema (TE)

  7 days

• Oral Health Impact Profile (OHIP)

  14 days

Study Arms (2)

Diabetic (D)

ACTIVE COMPARATOR

Palatal wound healing in diabetic patients

Procedure: Palatal Wound

Control Group (CG)

ACTIVE COMPARATOR

Palatal wound healing in normoglycemic patients

Procedure: Palatal Wound

Interventions

Palatal Wound PROCEDURE

With the goal to harvest the free gingival graft (FGG), an 8mm diameter scalpel will be used to ensure standardized wounds. Thereafter, a 2-mm thick FGG will be removed. The wound area will receive 4.0 silk sutures.

Control Group (CG); Diabetic (D)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (2)

College of Dentistry - São José dos Campos, Sao Paulo State University

São José dos Campos, São Paulo, 12245-310, Brazil

RECRUITING

Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe

São José dos Campos, São Paulo, 12245000, Brazil

RECRUITING

Related Publications (4)

• 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.

  PMID: 25373688 BACKGROUND

• 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.

  PMID: 30475285 BACKGROUND

• 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.

  PMID: 34215862 BACKGROUND

• 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.

  PMID: 24562700 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Controlled clinical study, non-randomized, prospective, blinded, with a three-month follow-up.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 6, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BR (2)