Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate

What Was Tested

The trial (not phased) is built around Neurotensin.

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.

It had three arms (groups): Control Group (CG) (sham comparator), Silk Fibroin Film - SF (experimental) and Neurotensin-loaded Silk Fibroin Film - SF + NT (experimental).

The palatal wound area will not receive any treatment.

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

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

The registry classes the interventions as device and procedure.

More on the Plan

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.

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.

Who Took Part

Enrollment: 66 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Neurotensin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Neurotensin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2020-09-01 with completion listed for 2022-06-21.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in the Remaining Wound Area (RWA) (time frame: baseline, 7, 14, 21, 30, 45 and 90 days after surgery).

It also tracked 10 secondary outcomes, for example Tissue Thickness, Scar and Tissue Colorimetry, Epithelialization, Early wound healing index, Tissue edema and Postoperative discomfort.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Neurotensin in 66 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Neurotensin compound page, all human trials.