Extracted SocketBTEIGNCT06687824
Effect of Black Tea Extract Impregnated Gauze on Extracted Socket
A study testing Black Tea Extract and 0.5% Povidone Iodine Impregnated Sterile Gauze in people with Extracted Socket, run by Manipal University College Malaysia at 1 site in Malaysia.
Trial summary
Black tea is made from the leaves of a bush called Camellia sinensis. The main difference between green tea and black tea is that green tea is not completely oxidized while black tea is fully oxidized. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Extracted Socket
- What is being tested?
- Black Tea Extract and 0.5% Povidone Iodine Impregnated Sterile Gauze
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Apr 2024to 14 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or more
- ASA1 (American Society of Anesthesiologists physical status classification 1) and ASA2 patient
Who cannot join
- Sensitive to black tea
- Using complementary medical methods (herbal medicine, etc.) within the past month
- History of exposure of surgery site to radiation
- Using any antibiotic, corticosteroid, anticoagulant and contraceptive drug over the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction: A Randomized Controlled Trial
Black tea is made from the leaves of a bush called Camellia sinensis. The main difference between green tea and black tea is that green tea is not completely oxidized while black tea is fully oxidized. Immediately after being harvested, the leaves of green tea are heated in order to halt the oxidation process, this ensures that the tea experiences minimal oxidation and stays a bright green color. Black tea, meanwhile, is allowed to fully oxidize after it is harvested. This means that the leaves turn brown or black, with green no longer present anywhere on the leaf. The chemical composition of black tea are tannins, theaflavins, carbohydrates, thearubigins, protein, flavonols, mineral matter, phenolic acids, volatiles, amino acids, methylxanthine. Among these, tannins play an important role in our research which helps in bleeding cessation after tooth extraction. Prolonged bleeding after tooth extraction can cause discomfort and thus affect patient's healthcare. Several methods have been proposed to enhance bleeding cessation, including the use of haemostatic agents and natural remedies such as tea. Black tea, in particular, has been suggested to have potential haemostatic properties due to its high content of tannins and flavonoids. However, the efficacy of black tea in promoting bleeding cessation after tooth extraction remains unclear. The purpose of this study is to evaluate the effect of black tea extract on primary bleeding cessation after extraction of molars. The study aims to investigate the potential benefits of black tea in reducing the bleeding time compared to a controlled group which uses normal sterile gauze. Our null hypothesis states that there is no difference in primary bleeding cessation time for black tea extract-impregnated sterile (BTE) gauze and 0.5% povidone iodine-impregnated sterile (PVI) gauze.
This study will be conducted in Oral Maxillofacial and Surgery Department in Polyclinic A, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-four randomly selected patients with molar extraction, satisfying the inclusion criteria and exclusion criteria stated. BTE gauze or PVI gauze will be placed at the freshly extracted socket after extraction. The state of bleeding of the socket is observed at 2,5 and 7 minutes.
- Conditions
- Extracted Socket
- Being tested
- Black Tea Extract, 0.5% Povidone Iodine Impregnated Sterile Gauze
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Tea ExtractOther
Sterile gauze is impregnated into 5ml of black tea-extract solution with tannin concentration 18.67mg/ml
0.5% Povidone Iodine Impregnated Sterile GauzeOther
Diluted povidone-iodine act as negative control is added into sterile gauze to color blind the involved subject and the operator
| Study group | Role | What they receive |
|---|---|---|
| Black Tea-Extract Impregnated Sterile Gauze | Experimental | Not described Receives: Other: Black Tea Extract |
| 0.5% Povidone Iodine Impregnated Sterile Gauze | Placebo comparator | Not described Receives: Other: 0.5% Povidone Iodine Impregnated Sterile Gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction
A stopwatch is used by the investigator to check the bleeding status of the extracted socket at 2, 5 and 7 minutes after compression of the socket with black tea extract-impregnated gauze or color-blinded sterile gauze
Measured: Primary bleeding cessation after extraction of molar is assessed up to 7 minutes
Secondary outcomes (1)
To Identify Adverse Effect of Black Tea-extract Impregnated Sterile Gauze and 0.5% Povidone Iodine Impregnated Sterile Gauze on Post-extraction Sites.
Evaluate the presence of adverse effect 3 days after extraction via phone
Measured: 3 days post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start2 Apr 2024
- Primary completion12 Dec 2024
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Extracted SocketStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manipal University College Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dato' Dr. Rusdi Bin Abd. Raman, Manipal University
- Investigators
- Sy Xuan Heng, Principal investigator, Manipal University College MalaysiaWan Ying Lim, Principal investigator, Manipal University College MalaysiaPei Wen Ho, Principal investigator, Manipal University College MalaysiaJia Xuan Lee, Principal investigator, Manipal University College MalaysiaCheryl Xue Rou Lee, Principal investigator, Manipal University College Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687824
- Sponsor's protocol ID
- MUCM/REC-042/2023
- Acronym
- BTEIG
- Status last verified
- May 2025
- First submitted
- 8 Nov 2024
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalalinia F, Amiri N, Mehrvarzian N, Fazly Bazzaz BS, Iranshahi M, Shahroodi A, Arabzadeh S, Abbaspour M, Badiee Aaval S, Movaffagh J. Topical green tea formulation with anti-hemorrhagic and antibacterial effects. Iran J Basic Med Sci. 2020 Aug;23(8):1085-1090. doi: 10.22038/ijbms.2020.41397.9782.
PubMed 32952956Kumbargere Nagraj S, Prashanti E, Aggarwal H, Lingappa A, Muthu MS, Kiran Kumar Krishanappa S, Hassan H. Interventions for treating post-extraction bleeding. Cochrane Database Syst Rev. 2018 Mar 4;3(3):CD011930. doi: 10.1002/14651858.CD011930.pub3.
PubMed 29502332Abbate R, Prisco D, Rostagno C, Boddi M, Gensini GF. Age-related changes in the hemostatic system. Int J Clin Lab Res. 1993;23(1):1-3. doi: 10.1007/BF02592271.
PubMed 8477086Le Blanc J, Lordkipanidze M. Platelet Function in Aging. Front Cardiovasc Med. 2019 Aug 7;6:109. doi: 10.3389/fcvm.2019.00109. eCollection 2019.
PubMed 31448291Chokotho L, van Hasselt E. The use of tannins in the local treatment of burn wounds - a pilot study. Malawi Med J. 2005 Jun;17(1):19-20. doi: 10.4314/mmj.v17i1.10866.
PubMed 27528993Marcinczyk N, Gromotowicz-Poplawska A, Tomczyk M, Chabielska E. Tannins as Hemostasis Modulators. Front Pharmacol. 2022 Jan 13;12:806891. doi: 10.3389/fphar.2021.806891. eCollection 2021.
PubMed 35095516Yerragudi N, Chawla JG, Kalidoss VK, Polineni S, Jayam C, Kumar C. The Optimal Hemostasis Duration After Tooth Extraction: A Randomized Controlled Trial. Cureus. 2023 Jan 3;15(1):e33331. doi: 10.7759/cureus.33331. eCollection 2023 Jan.
PubMed 36741661Chung KT, Wong TY, Wei CI, Huang YW, Lin Y. Tannins and human health: a review. Crit Rev Food Sci Nutr. 1998 Aug;38(6):421-64. doi: 10.1080/10408699891274273.
PubMed 9759559Soltani R, Haghighat A, Fanaei M, Asghari G. Evaluation of the effect of green tea extract on the prevention of gingival bleeding after posterior mandibular teeth extraction: a randomized controlled trial. Evid Based Complement Alternat Med. 2014;2014:857651. doi: 10.1155/2014/857651. Epub 2014 Jun 12.
PubMed 25024733Macpherson CR, Jacobs P. Bleeding time decreases with age. Arch Pathol Lab Med. 1987 Apr;111(4):328-9.
PubMed 3827541
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06687824
- Acronym / sponsor ID
- BTEIG / MUCM/REC-042/2023
- Conditions
- Extracted Socket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Manipal University College MalaysiaUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Black tea is made from the leaves of a bush called Camellia sinensis. The main difference between green tea and black tea is that green tea is not completely oxidized while black tea is fully oxidized. Immediately after being harvested, the leaves of green tea are heated in order to halt the oxidation process, this ensures that the tea experiences minimal oxidation and stays a bright green color. Black tea, meanwhile, is allowed to fully oxidize after it is harvested. This means that the leaves turn brown or black, with green no longer present anywhere on the leaf. The chemical composition of black tea are tannins, theaflavins, carbohydrates, thearubigins, protein, flavonols, mineral matter, phenolic acids, volatiles, amino acids, methylxanthine. Among these, tannins play an important role in our research which helps in bleeding cessation after tooth extraction. Prolonged bleeding after tooth extraction can cause discomfort and thus affect patient's healthcare. Several methods have been proposed to enhance bleeding cessation, including the use of haemostatic agents and natural remedies such as tea. Black tea, in particular, has been suggested to have potential haemostatic properties due to its high content of tannins and flavonoids. However, the efficacy of black tea in promoting bleeding cessation after tooth extraction remains unclear. The purpose of this study is to evaluate the effect of black tea extract on primary bleeding cessation after extraction of molars. The study aims to investigate the potential benefits of black tea in reducing the bleeding time compared to a controlled group which uses normal sterile gauze. Our null hypothesis states that there is no difference in primary bleeding cessation time for black tea extract-impregnated sterile (BTE) gauze and 0.5% povidone iodine-impregnated sterile (PVI) gauze.
This study will be conducted in Oral Maxillofacial and Surgery Department in Polyclinic A, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-four randomly selected patients with molar extraction, satisfying the inclusion criteria and exclusion criteria stated. BTE gauze or PVI gauze will be placed at the freshly extracted socket after extraction. The state of bleeding of the socket is observed at 2,5 and 7 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black Tea-Extract Impregnated Sterile Gauze | Experimental | Other: Black Tea Extract |
| 0.5% Povidone Iodine Impregnated Sterile Gauze | Placebo comparator | Other: 0.5% Povidone Iodine Impregnated Sterile Gauze |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or more
- ASA1 (American Society of Anesthesiologists physical status classification 1) and ASA2 patient
Key exclusion criteria (4 listed)
- Sensitive to black tea
- Using complementary medical methods (herbal medicine, etc.) within the past month
- History of exposure of surgery site to radiation
- Using any antibiotic, corticosteroid, anticoagulant and contraceptive drug over the past month
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 |
|---|---|---|
| Black Tea ExtractSterile gauze is impregnated into 5ml of black tea-extract solution with tannin concentration 18.67mg/ml | Other | Black Tea-Extract Impregnated Sterile Gauze |
| 0.5% Povidone Iodine Impregnated Sterile GauzeDiluted povidone-iodine act as negative control is added into sterile gauze to color blind the involved subject and the operator | Other | 0.5% Povidone Iodine Impregnated Sterile Gauze |
Primary outcome
Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction
Time frame: Primary bleeding cessation after extraction of molar is assessed up to 7 minutes
A stopwatch is used by the investigator to check the bleeding status of the extracted socket at 2, 5 and 7 minutes after compression of the socket with black tea extract-impregnated gauze or color-blinded sterile gauze
1 secondary outcome
To Identify Adverse Effect of Black Tea-extract Impregnated Sterile Gauze and 0.5% Povidone Iodine Impregnated Sterile Gauze on Post-extraction Sites.
Time frame: 3 days post-extraction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32952956Kalalinia F, Amiri N, Mehrvarzian N, Fazly Bazzaz BS, Iranshahi M, Shahroodi A, Arabzadeh S, Abbaspour M, Badiee Aaval S, Movaffagh J. Topical green tea formulation with anti-hemorrhagic and antibacterial effects. Iran J Basic Med Sci. 2020 Aug;23(8):1085-1090. doi: 10.22038/ijbms.2020.41397.9782.
- Background: PubMed 29502332Kumbargere Nagraj S, Prashanti E, Aggarwal H, Lingappa A, Muthu MS, Kiran Kumar Krishanappa S, Hassan H. Interventions for treating post-extraction bleeding. Cochrane Database Syst Rev. 2018 Mar 4;3(3):CD011930. doi: 10.1002/14651858.CD011930.pub3.
- Background: PubMed 8477086Abbate R, Prisco D, Rostagno C, Boddi M, Gensini GF. Age-related changes in the hemostatic system. Int J Clin Lab Res. 1993;23(1):1-3. doi: 10.1007/BF02592271.
- Background: PubMed 31448291Le Blanc J, Lordkipanidze M. Platelet Function in Aging. Front Cardiovasc Med. 2019 Aug 7;6:109. doi: 10.3389/fcvm.2019.00109. eCollection 2019.
- Background: PubMed 27528993Chokotho L, van Hasselt E. The use of tannins in the local treatment of burn wounds - a pilot study. Malawi Med J. 2005 Jun;17(1):19-20. doi: 10.4314/mmj.v17i1.10866.
- Background: PubMed 35095516Marcinczyk N, Gromotowicz-Poplawska A, Tomczyk M, Chabielska E. Tannins as Hemostasis Modulators. Front Pharmacol. 2022 Jan 13;12:806891. doi: 10.3389/fphar.2021.806891. eCollection 2021.
- Background: PubMed 36741661Yerragudi N, Chawla JG, Kalidoss VK, Polineni S, Jayam C, Kumar C. The Optimal Hemostasis Duration After Tooth Extraction: A Randomized Controlled Trial. Cureus. 2023 Jan 3;15(1):e33331. doi: 10.7759/cureus.33331. eCollection 2023 Jan.
- Background: PubMed 9759559Chung KT, Wong TY, Wei CI, Huang YW, Lin Y. Tannins and human health: a review. Crit Rev Food Sci Nutr. 1998 Aug;38(6):421-64. doi: 10.1080/10408699891274273.
- Results publication: PubMed 25024733Soltani R, Haghighat A, Fanaei M, Asghari G. Evaluation of the effect of green tea extract on the prevention of gingival bleeding after posterior mandibular teeth extraction: a randomized controlled trial. Evid Based Complement Alternat Med. 2014;2014:857651. doi: 10.1155/2014/857651. Epub 2014 Jun 12.
- Results publication: PubMed 3827541Macpherson CR, Jacobs P. Bleeding time decreases with age. Arch Pathol Lab Med. 1987 Apr;111(4):328-9.
- Use of ultraviolet germicidal irradiation on disinfectionLink provided by the sponsor.
- Time Required for Haemostasis under Pressure from Dental Extraction SocketLink provided by the sponsor.
- Tannins may be employed medicinally in antidiarrheal, haemostatic, and antihemorrhoidal compoundsLink provided by the sponsor.
- 96 weeks of storage time when medical items are stored in clean, sterile storage mediumLink provided by the sponsor.
- Effect of green tea on second degree burn wound in ratsLink provided by the sponsor.
- Quantitative estimation of tannins by HPLCLink provided by the sponsor.
- 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.
Sy Xuan Heng principal investigator
Manipal University College Malaysia
Wan Ying Lim principal investigator
Manipal University College Malaysia
Pei Wen Ho principal investigator
Manipal University College Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Tea Extract and 0.5% Povidone Iodine Impregnated Sterile Gauze in people with Extracted Socket, run by Manipal University College Malaysia at 1 site in Malaysia.
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 2 inclusion and 4 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 20 May 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 Malaysia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction (time frame: Primary bleeding cessation after extraction of molar is assessed up to 7 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06687824, which also lists 10 linked publications.
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 20 May 2025.