Extracted Socket
Conditions
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.
Interventions
OTHERBlack Tea Extract
Sterile gauze is impregnated into 5ml of black tea-extract solution with tannin concentration 18.67mg/ml
OTHER0.5% 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
Sponsors
Manipal University College Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Evaluate the presence of adverse effect 3 days after extraction via phone |
Countries
Malaysia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.5% Povidone Iodine Impregnated Sterile Gauze 5ml of 0.5% of povidone iodine solution is used for each gauze. | 22 |
| Black Tea-Extract Impregnated Sterile Gauze 5ml of black tea extract solution is used for each gauze with 18.67mg.ml tannin concentration. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | 0.5% Povidone Iodine Impregnated Sterile Gauze | Total | Black Tea-Extract Impregnated Sterile Gauze |
|---|---|---|---|
| Age, Customized 21-30 | 1 Participants | 4 Participants | 3 Participants |
| Age, Customized 31-40 | 2 Participants | 5 Participants | 3 Participants |
| Age, Customized 41-50 | 6 Participants | 8 Participants | 2 Participants |
| Age, Customized 51-60 | 6 Participants | 10 Participants | 4 Participants |
| Age, Customized less than 21 years old | 1 Participants | 6 Participants | 5 Participants |
| Age, Customized more than 60 years old | 6 Participants | 11 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 11 Participants | 29 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
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
Time frame: Primary bleeding cessation after extraction of molar is assessed up to 7 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 0.5% Povidone Iodine Impregnated Sterile Gauze | Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction | less than 2 minutes | 17 Participants |
| 0.5% Povidone Iodine Impregnated Sterile Gauze | Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction | 2-5 minutes | 4 Participants |
| 0.5% Povidone Iodine Impregnated Sterile Gauze | Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction | 6-7 minutes | 1 Participants |
| Black Tea-Extract Impregnated Sterile Gauze | Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction | less than 2 minutes | 12 Participants |
| Black Tea-Extract Impregnated Sterile Gauze | Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction | 2-5 minutes | 10 Participants |
| Black Tea-Extract Impregnated Sterile Gauze | Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction | 6-7 minutes | 0 Participants |
Secondary
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
Time frame: 3 days post-extraction
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 0.5% Povidone Iodine Impregnated Sterile Gauze | To Identify Adverse Effect of Black Tea-extract Impregnated Sterile Gauze and 0.5% Povidone Iodine Impregnated Sterile Gauze on Post-extraction Sites. | Not present | 22 Participants |
| 0.5% Povidone Iodine Impregnated Sterile Gauze | To Identify Adverse Effect of Black Tea-extract Impregnated Sterile Gauze and 0.5% Povidone Iodine Impregnated Sterile Gauze on Post-extraction Sites. | present | 0 Participants |
| Black Tea-Extract Impregnated Sterile Gauze | To Identify Adverse Effect of Black Tea-extract Impregnated Sterile Gauze and 0.5% Povidone Iodine Impregnated Sterile Gauze on Post-extraction Sites. | Not present | 22 Participants |
| Black Tea-Extract Impregnated Sterile Gauze | To Identify Adverse Effect of Black Tea-extract Impregnated Sterile Gauze and 0.5% Povidone Iodine Impregnated Sterile Gauze on Post-extraction Sites. | present | 0 Participants |