NCT05191082

Brief Summary

The aim of the present study will be to manufacture and characterize silk fibroin membranes loaded or not with neurotensin and to evaluate clinical, patient-centered and immunological parameters the effect of using these membranes on open wounds on the human palate.

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
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

December 23, 2021

Last Update Submit

January 12, 2022

Conditions

Wound HealingPalate; Wound

Keywords

PeriodontologyWound healingSilk fibroinRandomized clinical trialDrug Delivery System

Outcome Measures

Primary Outcomes (1)

  • Change in the Remaining Wound Area (RWA)

    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, 30, 45 and 90 days after surgery

Secondary Outcomes (10)

  • Tissue Thickness

    baseline, 45 and 90 days after the procedure

  • Scar and Tissue Colorimetry

    7, 14, 21, 30, 45 and 90 postoperative days

  • Epithelialization

    baseline, 3, 7, 14 and 30 days after the procedure

  • Early wound healing index

    7 and 14 days after surgery

  • Tissue edema

    7 days after the surgical procedure

  • +5 more secondary outcomes

Study Arms (3)

Control Group (CG)

SHAM COMPARATOR

The palatal wound area will not receive any treatment

Procedure: Palatal Wound

Silk Fibroin Film - SF

EXPERIMENTAL

The palatal wound area will receive silk fibroin film as a dressing

Procedure: Palatal WoundDevice: Palatal Wound treated with Silk Fibroin Film

Neurotensin-loaded Silk Fibroin Film - SF + NT

EXPERIMENTAL

The palatal wound area will receive a neurotensin-loaded silk fibroin film as a drug delivery system

Procedure: Palatal WoundDevice: Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film

Interventions

Palatal WoundPROCEDURE

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)Neurotensin-loaded Silk Fibroin Film - SF + NTSilk Fibroin Film - SF
Palatal Wound treated with Silk Fibroin FilmDEVICE

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 a silk fibroin film and 4.0 silk sutures.

Silk Fibroin Film - SF
Palatal Wound treated with Neurotensin-loaded Silk Fibroin FilmDEVICE

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 a silk fibroin film loaded with neurotensin and 4.0 silk sutures.

Neurotensin-loaded Silk Fibroin Film - SF + NT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at least 18 years old, healthy systemically, with good oral hygiene, assessed by means of a plaque index and gingival index less than 25% (O'Leary et al., 1972)
  • Patients with no morphological or pathological changes in the donor palatal region;
  • Patients who have an indication for extraction and with an indication to preserve the socket for future implant installation;
  • The tooth included in the study, as well as the adjacent teeth, must not have loss of periodontal insertion.

You may not qualify if:

  • Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, diabetes, among others), who contraindicate the surgical procedure;
  • Patients who use medications that interfere with wound healing;
  • Pregnant or lactating patients;
  • Patients who present opportunistic oral lesions, mainly colonizing the palate region;
  • Smoking patients;
  • Patients undergoing orthodontic treatment;
  • Patients already submitted to periodontal surgery in the area of interest in the present study;
  • Patients with a history of allergy to any type of material used in the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe

São José dos Campos, São Paulo, 12245000, Brazil

RECRUITING

Related Publications (4)

  • 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: 30475285BACKGROUND

  • 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: 25373688BACKGROUND

  • Zheng Z, Liu Y, Huang W, Mo Y, Lan Y, Guo R, Cheng B. Neurotensin-loaded PLGA/CNC composite nanofiber membranes accelerate diabetic wound healing. Artif Cells Nanomed Biotechnol. 2018;46(sup2):493-501. doi: 10.1080/21691401.2018.1460372. Epub 2018 Apr 13.

    PMID: 29653498BACKGROUND

  • Pereira da Silva L, Miguel Neves B, Moura L, Cruz MT, Carvalho E. Neurotensin decreases the proinflammatory status of human skin fibroblasts and increases epidermal growth factor expression. Int J Inflam. 2014;2014:248240. doi: 10.1155/2014/248240. Epub 2014 Aug 11.

    PMID: 25180119BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Mauro P Santamaria

    Sao Paulo States University - Brazil

    STUDY DIRECTOR

  • Ana Carolina F Bonafe

    Sao Paulo States University - Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro P Santamaria

CONTACT

1239479062mauro.santamaria@unesp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind, parallel, superiority, randomized clinical trial with a 3 months of follow-up
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 13, 2022

Study Start

September 1, 2020

Primary Completion

June 21, 2022

Study Completion

July 1, 2022

Last Updated

January 13, 2022

Record last verified: 2022-01

Locations

BR(1)