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

ConditionsPalate; WoundWound HealDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversidade Estadual Paulista Júlio de Mesquita Filho

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Palatal Wound

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Diabetic (D)Active comparator 1 intervention
Group B: Control Group (CG)Active comparator 1 intervention

Trial outcomes

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)

Time frame
baseline, 7, 14, 21 days after surgery

Secondary outcomes

1

Tissue Thickness (TT)

An endodontic spacer (Dentsply-Maillefer Instruments S.A. - Switzerland) with a rubber cursor will be placed in contact with the area until the palatal bone is reached, without pressing the tissue. The distance between the tip of the spacer and the cursor will be measured using a digital caliper (Dias et al., 2015).

Time frame
baseline, 90 days after surgery
2

Epithelialization (E)

The wound will be colored with Shirley's solution and the epithelialized area will be quantified in the Image J. program. Then, with the total wound area, the % epithelialization will be calculated (Ozcelik et al., 2008).

Time frame
baseline, 7, 14, 21, 30 e 90 days after surgery
3

Early wound healing index (EWHI)

According to Fickl et al. 2014 any modification in wound healing will be evaluated in five different degrees: Complete wound closure with an absence of fibrin on the palate; Complete wound closure with the presence of a fibrin line on palate; Complete wound closure with the presence of a clot with fibrin on palate Incomplete wound closure with partial tissue necrosis on palate; Incomplete wound closure with total tissue necrosis on palate

Time frame
7 and 14 days after surgery
4

Tissue Edema (TE)

Tissue edema will be evaluated with the score: 1 = absent; 2 = slight; 3 = moderate; or 4 = severe (Sanz-Moliner et, 2013).

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Estadual Paulista Júlio de Mesquita Filho

Lead sponsor

Source ClinicalTrials.gov
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