Use of Tilapia Skin for Palate Repair and Protection After Graft Removal

NCT04168125 | Completed Phase 1

• 1 other identifier: Ceap
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.

Conditions

Pain, Postoperative; Palate; Wound; Cicatrization

Outcome Measures

Primary Outcomes (1)

• Self-reported pain perception evaluated by a visual analog scale

  Patient's self-reported pain perception will be evaluated using a visual analog scale with a score ranging from 0 (no pain) to 10 (unbearable pain).

  14 days after the surgery

Secondary Outcomes (5)

• Self-reported discomfort evaluated by a visual analog scale

  14 days after the surgery

• Self-reported trouble with speech evaluated by a visual analog scale

  14 days after the surgery

• Self-reported trouble with eating evaluated by a visual analog scale

  14 days after the surgery

• Comparison of the palate healing process evaluated through linear measurements (millimiter)

  30 days after the surgery

• Number of analgesic pills taken after surgery

  14 days after the surgery

Study Arms (2)

Tilapia skin

EXPERIMENTAL

Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a tilapia skin as an occlusive biological dressing for palatal wound healing. Device: Tilapia skin. A xenogeneic collagen dressing will be placed over palate wound and stabilized with sutures during the healing process.

Device: Tilapia skin

Surgical Wound Dressing

ACTIVE COMPARATOR

Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a surgical wound dressing as a mechanical protection during palatal wound healing. Device: Surgical wound dressing A surgical wound dressing will be placed over palate wound during the healing process to provide mechanical protection.

Device: Surgical Wound Dressing

Interventions

Tilapia skin DEVICE

Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

Tilapia skin

Surgical Wound Dressing DEVICE

Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

Surgical Wound Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft

You may not qualify if:

• Patients with an infectious condition that compromises the procedures
• Users of drugs that can act on periodontal tissues or the healing process
• Pregnant
• Smokers
• Diabetes
• Irradiated

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Bauru School of Dentistry

Bauru, Brazil, 17012-901, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Wounds and Injuries; Cicatrix

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fibrosis

Study Officials

• Adriana CP Sant'Ana, PhD

  Bauru School of Dentistry - University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: November 19, 2019
• Study Start: September 26, 2019
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)