Efficacy and safety of topical tocopherols in oral biopsies
| ISRCTN | ISRCTN11647292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11647292 |
| Secondary identifying numbers | CESC 330n/AO/23 |
- Submission date
- 19/04/2023
- Registration date
- 09/05/2023
- Last edited
- 10/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The aim of this study is to evaluate the effectiveness of tocopherol acetate oral gel in reducing pain in patients undergoing oral biopsy (tissue sample). VEA filme os is a medical device in an oily gel formulation based on tocopherol acetate (vitamin E) used for the prevention and treatment of oral mucositis. Vitamin E promotes the healing of the skin and mucous membranes. Vea filme os forms a protective film and isolates the lesion in the mouth, and has already been used for some time to reduce surgical wound discomfort in patients undergoing oral biopsy.
Who can participate?
Adult patients who are undergoing an oral biopsy
What does the study involve?
One group receives standard of care (i.e. chlorhexidine) while the second group receives topical tocopherol gel treatment. Participants in the second group undergo three topical applications a day for 7 days after the oral biopsy, which involves spreading the gel on the lesion until it is covered. It is not necessary to massage and it is advisable to avoid touching the area even with the tongue for at least 1-2 minutes to favour the formation of the protective film. Patients are contacted by telephone as usual. Pain is assessed on days 1 and 6. Intake of painkillers will be recorded and evaluated.
What are the possible benefits and risks of participating?
There are no known undesirable effects related to the use of tocopherol acetate oral gel. Vitamin E toxicity is rare, but in high doses it can cause bleeding risk, as well as muscle weakness, fatigue, nausea and diarrhoea. Since the gel is applied to the mouth, sticks to the tissue and is ingested by the patient in minimal amounts, there is no risk of systemic overdose.
Where is the study run from?
HULKA srl (Italy)
When is the study starting and how long is it expected to run for?
January 2022 to July 2024
Who is funding the study?
HULKA srl (Italy)
Who is the main contact?
Christian Bacci, christian.bacci@unipd.it
Contact information
Scientific
via Giustiniani 1
Padova
35128
Italy
 ORCID ID |
0000-0002-6956-6227 |
|---|---|
| Phone | +39 (0)498212040 |
| christian.bacci@unipd.it |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Telephone, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Comparative efficacy of tocopherol (VEA film os) versus chlorhexidine in patients undergoing oral biopsies: a randomized case-control study |
| Study acronym | FOS |
| Study objectives | Evaluated topical application of a tocopherol-based gel can affect postoperative discomfort in oral biopsies |
| Ethics approval(s) | Approved 02/02/2023, Comitato Etico per La Sperimentazione Clinica Della Provincia Di Padova (Azienda Ospedale Università via Giustiniani 1, 35128, Padova, Italy; +39 (0)498215107; prc.unitaricercaclinica@aopd.veneto.it), ref: CESC 330n/AO/23 |
| Health condition(s) or problem(s) studied | Oral lesions |
| Intervention | Current interventions as of 10/09/2024: Patients with oral lesions requiring biopsy will be recruited. One group (control) receive standard of care i.e. chlorhexidine while the second group (case) receive topical tocopherol gel treatment. On days 1 and 6, the discomfort following the biopsy will be assessed using a visual analog scale (VAS). The study primary variable is the pain-related visual analogue scale (VAS-D) on the first and sixth postoperative day in patients who applied topical Vea filme os three times a day for 7 days on single or multiple oral mucosal biopsy samples. Concomitant intake of painkillers is recorded and evaluated. The same data is collected for control group. The statistical analysis is done with a Student's t-test and carried out with R 4.1 (R Foundation for Statistical Computing, Vienna, Austria). A p-value of less than 0.05 is considered statistically significant. The postoperative discomfort assessment is conducted by telephone on the sixth day. ____ Previous interventions: Patients with oral lesions requiring biopsy will be recruited. One group (control) receive standard of care i.e. no treatment while the second group (case) receive topical tocopherol gel treatment. On days 1 and 6, the discomfort following the biopsy will be assessed using a visual analog scale (VAS). The study primary variable is the pain-related visual analogue scale (VAS-D) on the first and sixth postoperative day in patients who applied topical Vea filme os three times a day for 7 days on single or multiple oral mucosal biopsy samples. Concomitant intake of painkillers is recorded and evaluated. The statistical analysis is done with a Student's t-test and carried out with R 4.1 (R Foundation for Statistical Computing, Vienna, Austria). A p-value of less than 0.05 is considered statistically significant. The postoperative discomfort assessment is conducted by telephone on the sixth day. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Tocopherol acetate oral gel with applicator |
| Primary outcome measure | Discomfort measured using a pain-related visual analog scale (VAS) on days 1 and 6 |
| Secondary outcome measures | Complications recorded by interviewing the patient after 1 and 6 days |
| Overall study start date | 01/01/2022 |
| Completion date | 31/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 for each group |
| Key inclusion criteria | 1. Patients undergoing biopsy of the oral cavity at the UOC Dental Clinic 2. Patients able to read and understand the information sheet and give informed consent 3. Patients who, after having been informed in detail about how to use Vea Filme os, have complied with the intake schedule |
| Key exclusion criteria | Current inclusion criteria as of 10/09/2024: 1. Patients with contraindications to surgery 2. Patients unable to give consent 3. Minor patients 4. Patients receiving antiangiogenic therapy 5. Patients receiving immunomodulator therapy 6. Patients with hypersensitivity to the Vea Filme os device _____ Previous exclusion criteria: 1. Patients with contraindications to surgery 2. Patients unable to give consent 3. Patients who took painkillers during the six study days 4. Minor patients 5. Patients receiving antiangiogenic therapy 6. Patients receiving immunomodulator therapy 7. Patients with hypersensitivity to the Vea Filme os device |
| Date of first enrolment | 28/02/2023 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Department of Neurosciences
Padova
35128
Italy
Sponsor information
Industry
Viale della Scienza, 26
Rovigo RO
45100
Italy
| Phone | +39 (0)425 171 3713 |
|---|---|
| info@hulka.it | |
| Website | https://www.hulka.it/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Patients accept the use of data for the purposes of scientific publication. Absolute anonymity in data processing is guaranteed. |
Editorial Notes
10/09/2024: The following changes were made to the trial record:
1. The scientific title was changed from "Efficacy and safety of topical tocopherols (VEA filme os) in patients undergoing oral biopsies: a randomized case-control study" to "Comparative efficacy of tocopherol (VEA film os) versus chlorhexidine in patients undergoing oral biopsies: a randomized case-control study".
2. The interventions were changed.
3. The exclusion criteria were changed.
03/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/06/2023 to 30/06/2024.
2. The overall study end date was changed from 31/07/2023 to 31/07/2024.
3. The intention to publish date was changed from 01/09/2023 to 01/09/2024.
03/05/2023: Study's existence confirmed by the Comitato Etico per La Sperimentazione Clinica Della Provincia Di Padova.
