NCT03972267

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

May 30, 2019

Last Update Submit

June 3, 2019

Conditions

Palatal Wound

Keywords

Wound HealingEnamel Matrix DerivativePalatal

Outcome Measures

Primary Outcomes (1)

  • Remaining wound area

    The defect area will be measured after 7 post-operative days. For this, standardized photography will be taken ( in terms of brightness, distance and angle). A scale will be used as a reference to measure the area. These photographs will be exported to image software (Image J-NIH, Bethesda, USA) and the wound area will be measured in square millimeters (mm2) (Dias et al. 2015).

    7 days

Secondary Outcomes (7)

  • Scar and tissue colorimetry

    30 days

  • Epithelialization

    7 days

  • Tissue thickness

    90 days

  • Postoperative discomfort

    7 days

  • Number of analgesics

    2 weeks

  • +2 more secondary outcomes

Study Arms (2)

Control Group - Free Gingival Graft

SHAM COMPARATOR

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.

Procedure: Free gingival graft

Test Group - Free Gingival Graft + EMD

EXPERIMENTAL

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

Procedure: Free gingival graftDevice: Enamel Matrix Derivate

Interventions

Free gingival graftPROCEDURE

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

Also known as: Socket preservation
Control Group - Free Gingival GraftTest Group - Free Gingival Graft + EMD
Enamel Matrix DerivateDEVICE

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

Test Group - Free Gingival Graft + EMD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

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 present opportunistic oral lesions mainly colonized the palate region;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuela Maria Viana Miguel

São José dos Campos, São Paulo, 12245200, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21235616BACKGROUND

  • 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.

    PMID: 25418917BACKGROUND

Study Officials

  • Mauro P Santamaria, PhD

    ICT- UNESP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro P Santamaria, PhD

CONTACT

+55 (12) 3947-9000mauro.santamaria@ict.unesp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 3, 2019

Study Start

June 1, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

BR(1)