The effectiveness and safety of oral adhesive bandage for extraction wound management
| ISRCTN | ISRCTN11589028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11589028 |
- Submission date
- 29/10/2023
- Registration date
- 20/11/2023
- Last edited
- 13/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study compares oral adhesive bandages with the classic compression method to evaluate this wound dressing material in improving postoperative comfort, wound healing and hemostasis (stopping bleeding) in tooth extraction.
Who can participate?
Adult patients requiring surgical removal of one single tooth
What does the study involve?
In this study, subjects are randomly assigned to one of two groups (a randomized controlled clinical trial): an experimental group receiving the intervention that is being tested, the oral adhesive bandages used as wound dressing, and the other (the comparison group or control) receiving an alternative (conventional) treatment. In the control group, patients bite cotton balls and gauze, which is the usual method of wound dressing. At postoperative 1 hour, 24 hours and 7 days, hemorrhage (bleeding), comfort and healing levels are evaluated. The adhesion time of oral adhesive bandages is also recorded. For every participant, the study lasts for one week.
What are the possible benefits and risks of participating?
Participants will benefit from discounts on surgery costs. There are risks of allergy towards oral adhesive bandages.
Where is the study run from?
Hospital of Stomatology, Wuhan University (China)
When is the study starting and how long is it expected to run for?
January 2022 to December 2023
Who is funding the study?
The Department of Oral and Maxillofacial Surgery, Hospital of Stomatology, Wuhan University (China)
Who is the main contact?
Dr. Zhou Xiaocheng, zhouxiaocheng@whu.edu.cn (China)
Contact information
Public, Scientific
Department of Oral and Maxillofacial Surgery
School & Hospital of Stomatology
237 Luoyu Road
Hongshan District
Wuhan
430079
China
 ORCID ID |
0000-0002-1726-952X |
|---|---|
| Phone | +8617762401922 |
| zhouxiaocheng@whu.edu.cn |
Principal Investigator
Department of Oral and Maxillofacial Surgery
School & Hospital of Stomatology
237 Luoyu Road
Hongshan District
Wuhan
430079
China
| ORCID ID |
0000-0001-8857-7557 |
|---|---|
| Phone | +8613607122535 |
| jhzhao988@whu.edu.cn |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format |
| Scientific title | Clinical trial to evaluate the effectiveness and safety of oral adhesive bandage for extraction wound management |
| Study acronym | EASOOABFEWM |
| Study objectives | The oral adhesive bandages are better than the conventional methods in hemostatic, healing and comforting effects on extraction wound management. |
| Ethics approval(s) |
Approved 25/03/2022, The Medical Ethics Committee in the Hospital of Stomatology, Wuhan university (237 Luoyu Road, Hongshan district, Wuhan, 430079, China; +86 027-87686250; wdkqllwyh@163.com), ref: 2022-C12 |
| Health condition(s) or problem(s) studied | Wound management in tooth extraction |
| Intervention | Patients in the control group bite cotton balls and gauze, while patients in the study group use oral adhesive bandages for extraction socket protection. Bleeding, comforting and healing levels of all patients are measured. The lottery method will be used for randomization. Participant's journey and follow-up: Screen, blood test, enrol and randomize, written informed consent, surgery, assess at postoperative 1 hour, assess at postoperative 24 hours, follow up and assess at postoperative 7 days. A single dentist performed extraction surgeries for all participants, another dentist assessed all participants without knowing their group. The hemostatic measures were performed individually after every extraction surgery. The hemostatic measures were performed upon extraction sockets. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oral adhesive bandages |
| Primary outcome measure | 1. Bleeding measured using a visual examination at 1 and 24 hours postoperative 2. Comfort level measured using a comfort rating scale 1-hour postoperative 3. Healing measured using a visual examination on postoperative day 7 4. Adhesion time of the oral adhesive bandages measured using a visual examination when oral adhesive bandages fall off |
| Secondary outcome measures | 1. Complications measured using patient self-reporting records within 7 days after surgery 2. The duration of extraction surgeries measured using recorded timekeeping from the beginning of surgery to the tooth is extracted |
| Overall study start date | 01/01/2022 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Aged between 18-65 years old 2. Requiring surgical removal of one single tooth (except upper and lower third molars) |
| Key exclusion criteria | 1. Menstruation 2. Pregnancy or lactation 3. Periodontitis 4. Tobacco usage 5. Coagulation disorders 6. Infection or immune dysfunction 7. A history of allergy to any drugs 8. Cyst or tumor 9. Unwillingness to participate |
| Date of first enrolment | 01/04/2022 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Hongshan district
Wuhan
430079
China
Sponsor information
Hospital/treatment centre
Department of Oral and Maxillofacial Surgery
School & Hospital of Stomatology
237 Luoyu Road
Hongshan District
Wuhan
430079
China
| Phone | +8687686386 |
|---|---|
| info@bonanga.com | |
| Website | https://whuss.com/article/8258 |
"ROR" |
https://ror.org/033vjfk17 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- 武汉大学, WHU
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed international journal |
| IPD sharing plan | The datasets generated and analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
13/11/2023: Study's existence confirmed by the Medical Ethics Committee in the Hospital of Stomatology, Wuhan University (China).
