Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction: A Randomized Controlled Trial
Phase: NA
Conditions: Extracted Socket
Sponsor: Manipal University College Malaysia

 
 
 
Evaluation of the Effect of Black Tea Extract on the 
Primary Bleeding Cessation after Molar Extraction: 
A Randomized Controlled Trial 
 
 
 
 
 
 
 
 
 
 
 
NCT number: NCT06687824 
Date: 1/5/2025 
 
 
 

1. Study Objectives  
     1.1 General Objectives: 
To evaluate the effect of black tea extract on bleeding cessation after molar extraction 
 
     1.2 Specific Objectives:  
a) To determine the bleeding cessation time with used of normal sterile gauze with 
0.5% povidone iodine (PVI)after molar extraction. 
b) To determine the bleeding cessation time with used of black tea extract-impregnated 
(BTEI) sterile gauze after molar extraction. 
c) To identify adverse effect of BTEI sterile gauze and PVI sterile gauze on post-
extraction sites. 
d) To compare the bleeding cessation with used of the BTEI sterile gauze and PVI sterile 
gauze on post-extraction area. 
2. Research Hypotheses  
There is no difference of bleeding cessation time between BTEI gauze and 0.5% PVI sterile 
gauze. 
 
 

3. Methodology 
     3.1 Preparation of Black Tea-Extract Impregnated Sterile Gauze 
For the preparation of black tea-extract impregnated (BTEI) gauze, 5 gauzes were prepared 
for each time. High-performance liquid chromatography (HPLC) was used to determine the 
tannin concentration in the black tea extract, which was 4.67 % w/w. 10 grams of black tea-
extract powder was mixed with 24ml of saline using magnetic stirrer with 200 rpm for 10 
minutes to achieve 18.67 mg/mL of tannin concentration in the solution. 5ml of solution was 
measured and inserted into sterilized ice cube tray. Sterile gauzes were soaked into each 
cube. It was covered with sterile lid and stored in 4 °C refrigerator for 24 hours for uniform 
absorption for each gauze. Then, the gauzes were sent for ultraviolet germicidal irradiation. 
10 minutes for 1 side and flipped the gauzes for another 10 minutes. After that, the gauzes 
were folded and packed into sterile sealed plastic bag until usage. 
    
     3.2 Preparation of 0.5% Povidone Iodine Impregnated Sterile Gauze  
5 gauzed were prepared at the same time together with BTEI gauzes. 5ml of 0.5% povidone 
iodine solution was inserted into each cube followed by soaking a gauze into each cube. The 
gauzes were stored in refrigerator and sent for ultraviolet germicidal irradiation together 
with BTEI gauzes.   
 
     3.3 Study Design and Intervention 
This is a randomized controlled trial performed in Manipal University College Malaysia’s 
(MUCM) Oral and Maxillofacial department (OMFS), from April to December 2024. The study 
protocol was approved Research Ethics Committee of MUCM (MUCM/ Research Ethics 
Committee- 042/2023). The trial is registered with National Clinical Trial Network with 
registration number NCT06687824. Informed consent from all participants was collected 
prior commencement of study. After selection of patient according to inclusion criteria and 
exclusion criteria, the demographic details (age, gender) of participants were recorded. 
Participants that are sensitive to black tea, use of complementary medical methods within 
the past month, having history of exposure of surgery site to radiation and use of antibiotic, 
corticosteroid, anticoagulant and contraceptive drug over the past month were excluded 
from the study.  After exclusion of participants, we included participants that were age ≥18 
years old and included in American Society of Anaesthesiologist (ASA) I and II. Those who 
met the inclusion and exclusion criteria were randomly selected and allocated into Group A 
and Group B using block randomization with block size 4.  
After patient selection and allocation, the extraction site was anaesthetized with 
mepivacaine hydrochloride 2%/ adrenaline 1:100,000 and molar was extracted with simple 

extraction without odontotomy, flap incision, flap elevation and bone removal. Time of 
extraction was within 20 minutes. After irrigating the socket with 0.5% povidone iodine 
solution, BTEI gauze was applied for intervention group and PVI gauze for control group. The 
primary bleeding cessation state was evaluated at 2, 5 and 7 minutes. The result was 
investigated and recorded as <2, 2-5, 6-7 and > 7 minutes. When the bleeding stopped, the 
participant was discharged and a new gauze was given and participant was instructed to bite 
the gauze for 1 hour. 3 days later, all participants were contacted for follow-up assessment 
via phone to evaluate the presence of adverse effect in all participants.   
 
4. Statistical Analysis Plan (SAP) 
4.1 Primary and Secondary Outcomes 
      4.1.1 Primary outcomes 
To evaluate the effect of BTEI gauze primary bleeding cessation after molar extraction.  
       4.1.2 Secondary Outcomes 
To identify the adverse effect of using BTEI gauze and PVI gauze  
 
4.2 Analysis Population  
After randomization, there was no dropouts,  Intent-to-Treat (ITT) and Per Protocol (PP) 
population were identical which was 44 participants, 22 participants for each group.  
 
4.3 Statistical Methods  
The demographic details of the participants were analysed using IBM SPSS Statistics version 
26. The primary bleeding cessation time at post-extraction site after using BTEI gauze and 
PVI gauze was assessed at 2,5 and 7minutes post-extraction and recorded using categorical 
method. The proportion of participants in each group achieving haemostasis at each time 
point will be compared using Chi-square test. A two-tailed p-value of less than 0.05 will be 
considered statistically significant. The assumption for the Chi-square test will be assessed 
prior to analysis.