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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black Tea-Extract Impregnated Sterile Gauze | Experimental |
| |
| 0.5% Povidone Iodine Impregnated Sterile Gauze | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black Tea Extract | Other | Sterile gauze is impregnated into 5ml of black tea-extract solution with tannin concentration 18.67mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Primary bleeding cessation after extraction of molar is assessed up to 7 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 days post-extraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sy Xuan Heng | Manipal University College Malaysia | Principal Investigator |
| Wan Ying Lim | Manipal University College Malaysia | Principal Investigator |
| Pei Wen Ho | Manipal University College Malaysia | Principal Investigator |
| Jia Xuan Lee | Manipal University College Malaysia | Principal Investigator |
| Cheryl Xue Rou Lee | Manipal University College Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manipal University College Malaysia | Malacca | 75150 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32952956 | Background | 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. | |
| 29502332 | Background |
| Label | URL |
|---|---|
| Use of ultraviolet germicidal irradiation on disinfection | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5% Povidone Iodine Impregnated Sterile Gauze | 5ml of 0.5% of povidone iodine solution is used for each gauze. |
| FG001 | Black Tea-Extract Impregnated Sterile Gauze | 5ml of black tea extract solution is used for each gauze with 18.67mg.ml tannin concentration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5% Povidone Iodine Impregnated Sterile Gauze | 5ml of 0.5% of povidone iodine solution is used for each gauze. |
| BG001 | Black Tea-Extract Impregnated Sterile Gauze | 5ml of black tea extract solution is used for each gauze with 18.67mg.ml tannin concentration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Primary bleeding cessation after extraction of molar is assessed up to 7 minutes |
|
3 days post-extraction
Participants were contacted via phone to evaluate the presence of adverse effect which was the presence of pain, irritation, burning sensation , itching sensation , fever and bad odor at the 3rd day after extraction.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.5% Povidone Iodine Impregnated Sterile Gauze | 5ml of 0.5% of povidone iodine solution is used for each gauze. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heng Sy Xuan | Manipal University College Malaysia | +601110752589 | hengsyxuan@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 | May 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| 0.5% Povidone Iodine Impregnated Sterile Gauze | Other | Diluted povidone-iodine act as negative control is added into sterile gauze to color blind the involved subject and the operator |
|
| Kumbargere 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. |
| 8477086 | Background | Abbate 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. |
| 31448291 | Background | Le Blanc J, Lordkipanidze M. Platelet Function in Aging. Front Cardiovasc Med. 2019 Aug 7;6:109. doi: 10.3389/fcvm.2019.00109. eCollection 2019. |
| 27528993 | Background | Chokotho 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. |
| 35095516 | Background | Marcinczyk 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. |
| 36741661 | Background | Yerragudi 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. |
| 9759559 | Background | Chung 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. |
| 25024733 | Result | Soltani 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. |
| 3827541 | Result | Macpherson CR, Jacobs P. Bleeding time decreases with age. Arch Pathol Lab Med. 1987 Apr;111(4):328-9. |
| Time Required for Haemostasis under Pressure from Dental Extraction Socket | View source |
| Tannins may be employed medicinally in antidiarrheal, haemostatic, and antihemorrhoidal compounds | View source |
| 96 weeks of storage time when medical items are stored in clean, sterile storage medium | View source |
| Effect of green tea on second degree burn wound in rats | View source |
| in vivo study on the effect of African black tea extract on wound healing | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 3 days post-extraction |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Black Tea-Extract Impregnated Sterile Gauze | 5ml of black tea extract solution is used for each gauze with 18.67mg.ml tannin concentration. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |