Effectiveness of green tea extract in preventing postoperative bleeding after dental extraction of mandibular molars
| ISRCTN | ISRCTN60510450 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60510450 |
- Submission date
- 02/11/2023
- Registration date
- 07/11/2023
- Last edited
- 08/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Post-extraction bleeding is a common complication after tooth extraction. The aim of this study is to investigate the effectiveness of different green tea extracts in reducing postoperative bleeding after the extraction of mandibular (lower jaw) molars.
Who can participate?
Patients aged 18 years and over attending dental clinics for extraction of lower molars
What does the study involve?
Patients are equally divided into four groups. In the first group, normal saline-soaked sterile gauze is used after tooth extraction while in the other three groups different green tea extracts (GTEs) are applied: in the second group methanolic GTE, in the third group aqueous GTE, and finally tannin in the fourth group. Bleeding is monitored every 5 minutes until bleeding stops and one hour after that.
What are the possible benefits and risks of participating?
Benefits include less bleeding after extraction and less possibility of complications. There are no risks as green tea is considered safe and the maximum dose is not exceeded.
Where is the study run from?
King Khalid University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
September 2022 to February 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mashail M.M. Hamid, mhamid@kku.edu.sa
Contact information
Principal Investigator
King Khalid University, Abha, KSA
Abha
61421
Saudi Arabia
 ORCID ID |
0000-0002-7743-1816 |
|---|---|
| Phone | +966 (0)555967705 |
| 3961181@myuwc.ac.za |
Public, Scientific
King Khalid University
Abha
61421
Saudi Arabia
| ORCID ID |
0000-0001-6642-4621 |
|---|---|
| Phone | +966 (0)553723498 |
| mmmostafa@kku.edu.sa |
Scientific
King Khalid University
Abha
61421
Saudi Arabia
| ORCID ID |
0000-0002-0217-8270 |
|---|---|
| Phone | +966 (0)534771942 |
| seudeabor@kku.edu.sa |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effectiveness of green tea extract as a local hemostatic agent after dental extraction of mandibular molars: a randomized clinical trial |
| Study objectives | Green tea extract is effective in reducing post-extraction bleeding when compared to standard methods. |
| Ethics approval(s) |
Approved 27/10/2022, Institutional Review Board, College of Dentistry, King Khalid University (King Khalid University, Abha, 61421, Saudi Arabia; N/A; src-cod@kku.edu.sa), ref: IRB/KKUCOD/ETH/2022-23/021 |
| Health condition(s) or problem(s) studied | Post-extraction bleeding |
| Intervention | Patients who were referred for extraction of mandibular molars at King Khalid University College of Dentistry clinics were selected and equally divided into the control and test groups (four groups). Randomization: 32 pieces of paper numbered from 1-4 were prepared to be used for the male patients and another 32 pieces for the females. Patients were asked to choose a numbered piece of paper (either 1, 2, 3, or 4) and accordingly, he/she received the corresponding intervention. Both patients and the principal investigator were blinded to the type of solution used. In the first group, normal saline-soaked sterile gauze was used after tooth extraction while in the three test groups, different Green Tea Extracts (GTEs) were applied, in the second group, methanolic GTE, in the third group, aqueous GTE and finally tannin in the fourth group. Monitoring of bleeding was performed every 5 minutes until cessation of bleeding and 1 hour after that. The results were compared using the Krushkal Wallis test, the Chi-Square test, and the Mann Whitney U test. |
| Intervention type | Other |
| Primary outcome measure | Post-extraction bleeding measured by checking the socket every 5 minutes by the principal investigator over 1 hour; after that patient was asked over the phone whether the bleeding continued or not |
| Secondary outcome measures | Post-extraction complications, measured by contacting patients by phone and asking about any complications on the same day of extraction and the following 3 days |
| Overall study start date | 01/09/2022 |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 66 |
| Key inclusion criteria | 1. Age ≥18 years 2. Willingness to participate in the study 3. Referred for extraction of mandibular molar |
| Key exclusion criteria | 1. Patients who have sensitivity to green tea 2. Patients who have a clotting disorder or liver disease 3. Patients who have an uncontrolled infection at the site of extraction 4. Patients with a history of malignancy or radiation at the site of extraction 5. Patients who have used antibiotics, corticosteroids, anticoagulants, and contraceptive drugs over the past month 6. Patients who are smokers 7. Patients with comorbidities (hypertension or diabetes) |
| Date of first enrolment | 01/11/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Abha
61421
Saudi Arabia
Sponsor information
University/education
Abha
Abha
61421
Saudi Arabia
| Phone | +966 (0)17 241 8000 |
|---|---|
| src-cod@kku.edu.sa | |
| Website | https://kku.edu.sa |
"ROR" |
https://ror.org/046gga527 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data will be available upon request from Dr Mashail Hamid (mhamid@kku.edu.sa). Shared data will be related to the measured variable, patient age and sex but not identity. It will be available from the present date up to 3 years (05/11/2023 to 05/11/2026). Signed consents were obtained from patients, and personal patient information (name, telephone no) was required for follow-up after they left the clinic. No ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2024 | 08/04/2025 | Yes | No |
Editorial Notes
08/04/2025: Publication reference added.
06/11/2023: Study's existence confirmed by the Institutional Review Board, King Khalid University.
