Effect of Black Tea Extract Impregnated Gauze on Extracted Socket (BTEIG)

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.

Study Overview

• Status: Completed
• Conditions: Extracted Socket
• Intervention / Treatment: Other: Black Tea Extract; Other: 0.5% Povidone Iodine Impregnated Sterile Gauze

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Melaka, Malaysia, 75150
    • Manipal University College Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 years or more
• ASA1 (American Society of Anesthesiologists physical status classification 1) and ASA2 patient

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Black Tea-Extract Impregnated Sterile Gauze	Other: Black Tea Extract; Sterile gauze is impregnated into 5ml of black tea-extract solution with tannin concentration 18.67mg/ml
Placebo Comparator: 0.5% Povidone Iodine Impregnated Sterile Gauze	Other: 0.5% Povidone Iodine Impregnated Sterile Gauze; Diluted povidone-iodine act as negative control is added into sterile gauze to color blind the involved subject and the operator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Manipal University College Malaysia
• Investigators: Principal Investigator: 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

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Macpherson CR, Jacobs P. Bleeding time decreases with age. Arch Pathol Lab Med. 1987 Apr;111(4):328-9.

Helpful Links

• Use of ultraviolet germicidal irradiation on disinfection
• Time Required for Haemostasis under Pressure from Dental Extraction Socket
• Tannins may be employed medicinally in antidiarrheal, haemostatic, and antihemorrhoidal compounds
• 96 weeks of storage time when medical items are stored in clean, sterile storage medium
• Effect of green tea on second degree burn wound in rats
• Quantitative estimation of tannins by HPLC
• in vivo study on the effect of African black tea extract on wound healing

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): December 14, 2024

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Infective Agents, Local; Plasma Substitutes; Blood Substitutes; Povidone; Povidone-Iodine
• Other Study ID Numbers: MUCM/REC-042/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No