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

M

Manipal University College Malaysia

Status

Completed

Conditions

Extracted Socket

Treatments

Other: 0.5% Povidone Iodine Impregnated Sterile Gauze
Other: Black Tea Extract

Study type

Interventional

Funder types

Other

Identifiers

NCT06687824
MUCM/REC-042/2023

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

44 participants in 2 patient groups, including a placebo group

Black Tea-Extract Impregnated Sterile Gauze
Experimental group
Treatment:
Other: Black Tea Extract
0.5% Povidone Iodine Impregnated Sterile Gauze
Placebo Comparator group
Treatment:
Other: 0.5% Povidone Iodine Impregnated Sterile Gauze

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Rusdi Bin Abd Raman Professor Dato'Dr

Data sourced from clinicaltrials.gov

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