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Completed

NCT Number: NCT06687824

Effect of Black Tea Extract Impregnated Gauze on Extracted Socket

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manipal University College Malaysia

Malacca, 75150, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Black tea extract

Other

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

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

Primary outcomes

  1. 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

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.

    Time frame: 3 days post-extraction

    Evaluate the presence of adverse effect 3 days after extraction via phone

Sponsors and collaborators

Lead sponsor

Manipal University College Malaysia

Other

Registry information

Official study title

Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction: A Randomized Controlled Trial

Acronym: BTEIG

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.