Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Surgical procedures for the reconstruction of gingival and peri-Implant tissues with the purpose of restoring function and aesthetics are commonly used in the dental practice. The use of free gingival graft (FGG), despite being considered the gold standard, causes great morbidity and postoperative pain. Thus, in order to reduce these complications, some biomaterials have been explored to accelerate healing and bring greater comfort to the patient. The present study aims to: 1. manufacture silk fibroin membranes (SF), loaded or not with neurotensin (NT); 2. evaluate, clinically and immunologically, the effect of the membranes on open wounds at palate sites. After the manufacture of the membranes they will be characterized by visual aspect, thickness, mechanical properties, surface texture, water vapor permeability, enzymatic degradation and swelling. Posteriorly, sixty six (n = 66) patients requiring exodontia and ridge preservation for future implant placement will be randomly assigned into three groups: Control - Free Gingival Graft (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance; Group SF - Fibroin membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of the fibroin membrane at the palatal wound site; Group SF + NT - Free Gingival Graft + Neurotensin-loaded Fibroin Membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of neurotensin-loaded fibroin membrane at the palatal wound site. The repair of the palatine donor area will be evaluated by clinical parameters such as remaining wound area, tissue thickness, re-epithelialization and early-wound healing index at baseline, 7, 14, 21, 30, 45, and 90 days after the procedure; and patient-centered outcomes by post-operative discomfort, tissue edema and number of analgesic pills used for 14 days after the procedure. In addition, inflammatory cytokines and growth factors will be assessed using the palatal wound inflammatory exudate 3 and 7 days after surgery. For the descriptive statistics, the mean ± standard deviation will be used; Normality: Shapiro-Wilk test; Clinical trials: ANOVA for intra and inter group calculations + Tukey test for multiple comparisons when the Shapiro-Wilk p value ≥ 0.05. If p Shapiro-Wilk <0.05, will be analyzed using the Friedman test (intragroup) and Mann-Whitney tests (intergroup); Parameters centered on patients: T test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05191082
Study type Interventional
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact Mauro P Santamaria
Phone 1239479062
Email mauro.santamaria@unesp.br
Status Recruiting
Phase N/A
Start date September 1, 2020
Completion date July 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT05045183 - A Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated N/A
Enrolling by invitation NCT04613336 - Efficacy of Topical Heparin Spray on Donor Site Wound Healing Time Compared to Conventional Dressing Among Patients Undergoing Split Thickness Skin Grafting
Recruiting NCT02241811 - Wound Treatment With 3% Sodium Pentaborate Pentahydrate Phase 1
Completed NCT02797899 - Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft N/A
Completed NCT01227759 - Tyrosur® Gel-Investigation on Wound Healing Efficacy Phase 2
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Completed NCT00736593 - A Study Evaluating Nexagon™ in the Treatment of Skin Wounds. Phase 1
Completed NCT00977951 - Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects Phase 1/Phase 2
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT05942235 - The Use of Microlearning in Nursing Education
Completed NCT03433820 - Wound Healing in Healthy Volunteers N/A
Withdrawn NCT02383992 - Postoperative Care of Sutured Wounds N/A
Recruiting NCT02034539 - VADOplex Critical Limb Ischemia Study Phase 2/Phase 3
Recruiting NCT01680042 - Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy Phase 1
Completed NCT01734317 - An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver. N/A
Completed NCT01115218 - The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
Withdrawn NCT01008111 - Wound Healing of Incisional Wounds for Bilateral Hernia Repair Phase 1
Terminated NCT00177060 - Topical Hydromorphone for Wound Healing Phase 1/Phase 2
Completed NCT00984503 - Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites Phase 2