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

NCT ID: NCT03972267

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2019-10-31

Brief Summary

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.

Detailed 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

Conditions

Palatal Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group - Free Gingival Graft

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.

Group Type: SHAM_COMPARATOR

Free gingival graft

Intervention Type: PROCEDURE

Free Gingival Graft removal from the palate donor area for socket preservation

Test Group - Free Gingival Graft + EMD

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

Group Type: EXPERIMENTAL

Free gingival graft

Intervention Type: PROCEDURE

Free Gingival Graft removal from the palate donor area for socket preservation

Enamel Matrix Derivate

Intervention Type: DEVICE

EMD in contact with the palate wound for 5 min. After this time, palatal area will be covered with an individualized acetate plate which will stay in position for 2 hours after the procedure

Interventions

Free gingival graft

Free Gingival Graft removal from the palate donor area for socket preservation

Intervention Type: PROCEDURE

Enamel Matrix Derivate

EMD in contact with the palate wound for 5 min. After this time, palatal area will be covered with an individualized acetate plate which will stay in position for 2 hours after the procedure

Intervention Type: DEVICE

Other Intervention Names

Socket preservation

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Mauro Pedrine Santamaria

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro P Santamaria, PhD

Role: PRINCIPAL_INVESTIGATOR

ICT- UNESP

Locations

Manuela Maria Viana Miguel

São José dos Campos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Mauro P Santamaria, PhD

Role: CONTACT

mauro.santamaria@ict.unesp.br

+55 (12) 3947-9000

Facility Contacts

Manuela Maria V Miguel

Role: primary

vianamiguel.manuela@gmail.com

(+55) 11 992655540

References

Nokhbehsaim M, Winter J, Rath B, Jager A, Jepsen S, Deschner J. Effects of enamel matrix derivative on periodontal wound healing in an inflammatory environment in vitro. J Clin Periodontol. 2011 May;38(5):479-90. doi: 10.1111/j.1600-051X.2010.01696.x. Epub 2011 Jan 16.

Reference Type: BACKGROUND

PMID: 21235616 (View on PubMed)

Miron RJ, Dard M, Weinreb M. Enamel matrix derivative, inflammation and soft tissue wound healing. J Periodontal Res. 2015 Oct;50(5):555-69. doi: 10.1111/jre.12245. Epub 2014 Nov 23.

Reference Type: BACKGROUND

PMID: 25418917 (View on PubMed)

Other Identifiers

UEPJMF10

Identifier Type: -

Identifier Source: org_study_id