Pain, PostoperativePhase 1NCT04168125
Use of Tilapia Skin for Palate Repair and Protection After Graft Removal
A Phase 1 study testing Tilapia skin and Surgical Wound Dressing in people with Pain, Postoperative and Palate; Wound, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Palate; Wound, Cicatrization
- What is being tested?
- Tilapia skin and Surgical Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Sep 2019to 2 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.
Read the detailed description
Autogenous grafts are currently considered the gold standard in regenerative and reconstructive procedures. However, these procedures require a second surgical site to provide the tissue graft. In autogenous gingival grafts, the area commonly selected for graft harvesting is the palate, which is linked to great discomfort and morbidity for the patient. In order to overcome these limitations, xenogeneic and alloplastic materials have been tested as tissue substitutes, but their results are still considerably inferior when compared to autogenous grafts. Faced with this superiority, another approach to favor the use of autogenous grafting is to develop materials that provide greater postoperative comfort and patient safety. Since the main complaint arising from the technique is related to pain resulting from the remaining surgical wound on the palate, it is interesting to look for mechanisms to reduce this sensitivity and accelerate the healing process. For this, the use of tilapia skin as a postoperative dressing seems to be a good alternative. Thus, the purpose of this study is to evaluate the use of tilapia skin, with the intention of accelerating the palate healing process, and to serve as a protector barrier during the healing process. Patients treated according to two techniques for palate protection after autogenous gingival graft harvesting will be evaluated: C- use of surgical cement and T- use of tilapia skin. Will be selected 60 patients of both sexes,> 18 years old, requiring the removal of the palate graft for periodontal surgery. At the time of graft removal, palate thickness and graft dimensions will be measured. After 7, 14 and 30 days, the patient's discomfort and the difficulty in chewing and speaking will be recorded through a visual analog scale, the consumption of analgesic, and the dimensions of the surgical wound on the palate. For statistical analysis, two-way ANOVA will be performed and t-test paired on the obtained results.
- Conditions
- Pain, Postoperative, Palate; Wound, Cicatrization
- Being tested
- Tilapia skin, Surgical Wound Dressing
- Medical subject headings
- Pain, Postoperative, Wounds and Injuries, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tilapia skinDevice
Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
Surgical Wound DressingDevice
Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Surgical Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days after the surgery
Secondary outcomes (5)
Self-reported discomfort evaluated by a visual analog scale
Patient's self-reported discomfort will be evaluated using a visual analog scale with a score ranging from 0 (no discomfort) to 2 (high discomfort).
Measured: 14 days after the surgery
Self-reported trouble with speech evaluated by a visual analog scale
Patient's self-reported trouble with speech will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).
Measured: 14 days after the surgery
Self-reported trouble with eating evaluated by a visual analog scale
Patient's self-reported trouble with eating will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).
Measured: 14 days after the surgery
Comparison of the palate healing process evaluated through linear measurements (millimiter)
Pictures will be taken immediately after the gingival graft harvesting and compared with post-operativa pictures through the use of linear measurements at Image J.
Measured: 30 days after the surgery
Number of analgesic pills taken after surgery
Evaluate the patient's perception of postoperative pain and discomfort by counting the number of analgesic pills taken after the surgery.
Measured: 14 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start26 Sep 2019
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Gonçalves do Prado Manfredi, University of Sao Paulo
- Investigators
- Adriana CP Sant'Ana, PhD, Study director, Bauru School of Dentistry - University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168125
- Sponsor's protocol ID
- Ceap
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2019
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tilapia Skin for Palate Repair and Protection After Graft Removal
- ClinicalTrials.gov ID
- NCT04168125
- Acronym / sponsor ID
- Ceap
- Conditions
- Pain, Postoperative, Palate; Wound, Cicatrization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.
Detailed description
Autogenous grafts are currently considered the gold standard in regenerative and reconstructive procedures. However, these procedures require a second surgical site to provide the tissue graft. In autogenous gingival grafts, the area commonly selected for graft harvesting is the palate, which is linked to great discomfort and morbidity for the patient. In order to overcome these limitations, xenogeneic and alloplastic materials have been tested as tissue substitutes, but their results are still considerably inferior when compared to autogenous grafts. Faced with this superiority, another approach to favor the use of autogenous grafting is to develop materials that provide greater postoperative comfort and patient safety. Since the main complaint arising from the technique is related to pain resulting from the remaining surgical wound on the palate, it is interesting to look for mechanisms to reduce this sensitivity and accelerate the healing process. For this, the use of tilapia skin as a postoperative dressing seems to be a good alternative. Thus, the purpose of this study is to evaluate the use of tilapia skin, with the intention of accelerating the palate healing process, and to serve as a protector barrier during the healing process. Patients treated according to two techniques for palate protection after autogenous gingival graft harvesting will be evaluated: C- use of surgical cement and T- use of tilapia skin. Will be selected 60 patients of both sexes,> 18 years old, requiring the removal of the palate graft for periodontal surgery. At the time of graft removal, palate thickness and graft dimensions will be measured. After 7, 14 and 30 days, the patient's discomfort and the difficulty in chewing and speaking will be recorded through a visual analog scale, the consumption of analgesic, and the dimensions of the surgical wound on the palate. For statistical analysis, two-way ANOVA will be performed and t-test paired on the obtained results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tilapia skin | Experimental | Device: Tilapia skinProcedure/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. |
| Surgical Wound Dressing | Active comparator | Device: Surgical Wound DressingProcedure/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tilapia skinApplication tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting. | Device | Tilapia skin |
| Surgical Wound DressingApplication surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting. | Device | Surgical Wound Dressing |
Primary outcome
Self-reported pain perception evaluated by a visual analog scale
Time frame: 14 days after the surgery
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).
5 secondary outcomes
Self-reported discomfort evaluated by a visual analog scale
Time frame: 14 days after the surgery
Self-reported trouble with speech evaluated by a visual analog scale
Time frame: 14 days after the surgery
Self-reported trouble with eating evaluated by a visual analog scale
Time frame: 14 days after the surgery
Comparison of the palate healing process evaluated through linear measurements (millimiter)
Time frame: 30 days after the surgery
Number of analgesic pills taken after surgery
Time frame: 14 days after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana CP Sant'Ana, PhD study director
Bauru School of Dentistry - University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tilapia skin and Surgical Wound Dressing in people with Pain, Postoperative and Palate; Wound, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain perception evaluated by a visual analog scale (time frame: 14 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.