Effect of Black Tea Extract Impregnated Gauze on Extracted Socket

NCT06687824 | Completed Results DMC

• 1 other identifier: MUCM/REC-042/2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 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.

  3 days post-extraction

Study Arms (2)

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

Interventions

Black Tea Extract OTHER

Sterile gauze is impregnated into 5ml of black tea-extract solution with tannin concentration 18.67mg/ml

Black Tea-Extract Impregnated Sterile Gauze

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

0.5% Povidone Iodine Impregnated Sterile Gauze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manipal University College Malaysia: lead

Study Sites (1)

Manipal University College Malaysia

Malacca, 75150, Malaysia

Location

Related Publications (10)

• 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.

  PMID: 32952956 BACKGROUND

• 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.

  PMID: 29502332 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.

  PMID: 8477086 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.

  PMID: 31448291 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.

  PMID: 27528993 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.

  PMID: 35095516 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.

  PMID: 36741661 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.

  PMID: 9759559 BACKGROUND

• 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.

  PMID: 25024733 RESULT

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

  PMID: 3827541 RESULT

Related 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

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Heng Sy Xuan
• Organization: Manipal University College Malaysia

hengsyxuan@hotmail.com

+601110752589

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dato' Dr.

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 14, 2024
• Study Start: April 2, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 14, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)