Influence of Enamel Matrix Derivative (Emdogain®) on Palate Wound Healing.

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Unknown

Conditions: Palatal Wound

Treatments: Procedure: Free gingival graft; Device: Enamel Matrix Derivate

Study type: Interventional

Funder types: Other

Identifiers

NCT03972267

UEPJMF10

Details and patient eligibility

About

The objective of this study is to evaluate clinical and patients-centered parameters of 3-month outcome of the enamel-derived matrix (EMD) application on wound healing process of the donor palatal area after free gingival graft (FGG) removal.

Full description

This is a randomized, parallel, double-blind clinical trial. The population that will be evaluated in this is study will be select at Science and Technology Institute - ICT-Sao Jose dos Campos, College of Dentistry.

Patients will be assigned to one of the treatments groups:

• Control Group - Free Gingival Graft (n = 22): Atraumatic extraction surgery and free gingival graft for sealing the entrance of the alveolus
• Test Group - Free Gingival Graft + EMD (n = 22): Atraumatic extraction surgery with placement of a free gingival graft to seal the entrance of the alveolus associated with EMD in the open wound on the palate.

All surgeries will be performed by the same expert periodontist (MMVM). A blade 15c (Swann-Morton® - Sheffield, England) mounted on No. 3 scalpel handle will make an intrasulcular incision around the tooth indicated for exodontia. Then, the tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. With the aim to ridge preservation after tooth extraction the socket will be sealed with a free gingival graft removed from the palate. For the free gingival graft removal, a circular template of 8 millimeters in diameter will be used. This stent has the objective of standardizing the palatal graft removal ensuring the wounds will have always the same size. After the circular incision, the graft will be removed with a thickness of 2 millimeters. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured with Vicryl® 5.0 reabsorbable (Ethicon Johnsons do Brasil, São José dos Campos - SP).

After the graft position, EMD will be applied immediately after the graft removal surgical procedure on the palatal donor area, leaving it in contact with the wound for 5 min. In sequence, it will be covered with an individualized acetate plate that will extend throughout the palatal area and be in position for 2 hours after the procedure.

The evaluated clinical parameters will be: wound remaining area (WRA), scar and tissue colorimetry (TC), tissue thickness (TT) and epithelization (E). Moreover, patient-centered also will be evaluated as: number of pills (NP), tissue edema (TE), postoperative discomfort (D) and Oral Health Impact Profile (OHIP).

All data will be expressed as mean ± standard deviation (SD), and normality will be tested using the Shapiro-Wilk test. Values for remaining wound area, scar and tissue colorimetry, tissue thickness, and epithelization will be examined by repeated measures ANOVA to assess differences within and between groups, followed by a Tukey test for multiple comparisons when the value of p Shapiro-Wilk ≥ 0.05. Those with Shapiro-Wilk p values <0.05 will be analyzed using the Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Values referring to patient-centered parameters such as postoperative discomfort, the number of analgesics taken, tissue edema and oral health impact profile measurements will be analyzed using the T-Test

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with at least 18 years of age, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index of less than 25% (O'Leary et al., 1972);
• Patients with no morphological or pathological changes in the donor palatine region;
• Patients who present an indication of exodontia and with ridge preservation indication for future implantation of implants;
• The tooth included in the study, as well as the adjacent teeth, do not present a loss of periodontal insertion;
• Patients who agreed to and signed 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).

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 present opportunistic oral lesions mainly colonized the palate region;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Control Group - Free Gingival Graft

Sham Comparator group

Description:

With the aim to ridge preservation after condemned tooth extraction, the socket will be sealed with a free gingival graft removed from the palate. The tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. After the exodontia, curettage and irrigation of the dental socket will be performed. The free gingival graft will be removed from the donor palatal area with a circular incision of 8 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. Patient randomized to the Control Group will not receive any kind of treatment in the palatal region.

Treatment:

Procedure: Free gingival graft

Test Group - Free Gingival Graft + EMD

Experimental group

Description:

With the aim to ridge preservation after condemned tooth extraction, the socket will be sealed with a free gingival graft removed from the palate. The tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. After the exodontia, curettage and irrigation of the dental socket will be performed. The free gingival graft will be removed from the donor palatal area with a circular incision of 8 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. EMD will be applied immediately after the graft removal surgical procedure on the palatal donor area, leaving it in contact with the wound for 5 min. In sequence, it will be covered with an individualized acetate plate that will extend throughout the palatal area and be in position for 2 hours after the procedure

Treatment:

Device: Enamel Matrix Derivate

Procedure: Free gingival graft