To evaluate the efficacy and safety of Tranexamic Acid Mouthwash to reduce bleeding in subject undergoing tooth extraction.
Scientific Title of Study
A Randomised, Double-blind, Multicenter, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Tranexamic Acid Mouthwash of Morningside Healthcare Limited, UK, to Reduce Bleeding in Subjects undergoing Tooth Extraction Who Are on Drugs Affecting Hemostasis.
Department of Dentistry, C Block, Ground Floor, All India Institute of Medical Sciences, G E Road, Tathibandh, Raipur, Chattisgarh- 492099, India Raipur CHHATTISGARH
9981525599
santhosh@aiimsraipur.edu.in
Dr Ramita Sood
AMC Dental College and Hospital
Oral and Maxillofacial Surgery Department,Oral Surgery division,Ground Floor,AMC Dental College and Hospital ,Bhalakiya Mill Compound,Opposite Anupam Cinema,Khokhra Ahmadabad GUJARAT
9825325230
ramita_sood@rediffmail.com
Dr Parth Satapara
Anand Multispeciality Hospital and Research Centre
Anand Multispeciality Hospital and Research Centre,
4th floor, Sarthak Mall, Mahatma Mandir Road,
Sargasan Cross Road, Gandhinagar Raod, Ahmedabad-382421 Ahmadabad GUJARAT
8866552094
drparthasatapara@gmail.com
Dr Amrita Gujral
Batra Hospital & Medical Research Center (B.H.M.R.C)
Department of Dentistry,Ground Floor,Block A,Batra Hospital &
Medical Research Center, 1Tughlakabad
Institutional Area, M B Road New Delhi 110062 North DELHI
9810525507
amritagujral@yahoo.com
Dr Prem Narayan Gupta
Charak Hospital and Research Center
Research unit, Room No-402,Fourth Floor,Charak Hospital and
Research Center,Hardoi Road,
Dubbaga Lucknow UTTAR PRADESH
9936195371
pgdrprem@gmail.com
Dr Nanditha Hegde
Father muller research centre
Father muller research centre,
Near indoor stadium, Father Muller campus,
Father Muller road,
Father Muller Medical College and Hospital
Kankanady Mangalore -575002.
Dakshina Kannada KARNATAKA
9900002312
nanditahegde@hotmail.com
Dr Gunjan Shah
GCS Medical College, Hospital & Research Centre
OPD Room number 38 and 39, Ground Floor, Medical Hospital Building, GCS Hospital Medical College & Research Centre (GCSHMC&RC), Opp. D. R.M. Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad, Gujarat-380025 Ahmadabad GUJARAT
9328993539
ghs_48@yahoo.com
Dr Neeta Mohanty
Institute of Dental Sciences (IDS)
1 st floor, Dean office, SUM Hospital,
Shampur, Bhubaneswar,
Odisha 751003
Khordha ORISSA
7381036061
dr.neetamohanty@gmail.com
Dr Balram Choudhary
Jawahar Lal Nehru (JLN) Medical College
Jawahar Lal Nehru Medical College, Department of Dentistry, Kala Bagh, Ajmer, Rajasthan - 302039, India. Ajmer RAJASTHAN
8118877284
clinical.jln@gmail.com
Dr Chandan S N
JSS Dental College & Hospital
JSS Dental College & Hospital Department of Oral & Maxillofacial Surgery, Sri Shivarathreeshwara Nagara, Bannimantap, Mysuru, Karnataka 570015. Mysore KARNATAKA
9448307430
dr.chandansn@jssuni.edu.in
Dr Manohara A Bhat Y
K. R. Hospital
Department of Dentistry, MMCRI, K. R. hospital, Irwin road, Mysuru (Mysore), Karnataka – 570001, India. Mysore KARNATAKA
8123389083
manoharpangala@gmail.com
Dr Sudharshan
KLES Institute of Dental Sciences and Research Center
OPD Room no -01 ,Department of Oral Maxilliofacial Surgery ,First Floor,KLES Institute of Dental Sciences and Research Center,Yeshwanthpur
Suburb, Tumkur Road,
Banglore Bangalore KARNATAKA
Ground Floor,Dept. of oral & Maxillofacial Surgery, Mallareddy Dental College, Suraram X Road, Jeedimetla,
Suraram, Telengana Hyderabad TELANGANA
9849356046
srinivasomfs@gmail.com
Dr Premalatha Shetty
Manipal College of Dental Sciences
second Floor,Department of Oral and
Maxillofacial Surgery,Manipal College of
Dental Sciences, Light house Hill Road,
Mangaluru Dakshina Kannada KARNATAKA
9448509022
premalatha.shetty@manipal.edu
Dr Rekha Gupta
Maulana Azad Dental College
Department of Prosthodontics,Room no-215,Second Floor-Maulana Azad Dental
College,Mirdard Marg,Bahadur Shah Zafar Marg,LNJP Colony,New Delhi North DELHI
01123233925
registrarmaids@yahoo.com
Dr Gaurav Mahesh Gupta
Pushpanjali Hospital
first Floor-Dept. of Oral & Maxillo-Facial Surgery Pushpanjali Hospital, Agra, Pushpanjali Palace, Delhi Gate Agra UTTAR PRADESH
8954893952
info@pushpanjalihospital.in
Dr Ashwin Prabhu
Rajalakshmi Hospital & Research Center
Rajalakshmi Hospital & Research Center, Ground floor, Dental Department, 21/1, Lakshmipura Main Road, Opp. Lakshmipura Lake, Vidyaranyapura Post, Bangalore, Urban Karnataka 560097, India Bangalore KARNATAKA
9845011615
prabhu.ash@gmail.com
Dr Utkal Mohanty
SCB Dental Collegeand Hospital
Department of Public Health Dentistry, SCB Dental College and Hospital Cuttack,Room No-9,second Floor Cuttack ORISSA
9437953285
utkalcommunity@gmail.com
Dr Prasad Bhange
Seth G.S. Medical College & KEM Hospital
Room No 104,Old building, First Floor,Department of Dentistry Seth G S Medical College and KEM Hospital,Acharya Donge Marg, Parel Mumbai MAHARASHTRA
Government Medical College & SSG Hospital,OPD-14, First floor, Department of Dentistry, Jail Road, Indira Avenue, Sayajigunj, Vadodara - 390001, Gujarat, India. Vadodara GUJARAT
8980809588
drshoyebshaikh@yahoo.com
Dr Rajkumar GC
VS Dental College and Hospital, Kempagowda Institute of Medical Sciences
Department. of Oral & Maxillo facial Surgery,first floor, Room no 03-VS Dental College and Hospital, Kempagowda Institute of Medical Sciences
Krishna Rajendra Road,Parvathipuram,Vishweshwarapura,Basavagudi Bangalore KARNATAKA
1) Male and/or female subject of 18 or greater of age having planned one tooth or two teeth extraction.
2) Subject who is on oral anticoagulant and/or antiplatelet therapy at the time of screening.
3) Platelet count within 5 days prior to the procedure should be more than 50000 /cubic millimetre (cmm).
4) Subject willing to provide written informed consent prior to study.
5) Not having taken oral anticoagulant drugs on the day of extraction.
6) Subject willing and able to take the assigned study medication as directed, comply with all study procedures and commit to come for the follow-up visits for the entire duration of the study.
7) Women of childbearing potential must have negative pregnancy test.
ExclusionCriteria
Details
1) Subject with clinically significant abnormal coagulation tests at the
time of screening.
2) Female subject, who is pregnant, breastfeeding, or planning to become pregnant during the study period.
3) History of hypersensitivity to the study drug or any of the ingredients.
4) Subject with International Normalised Ratios (INR) >3.5.
5) Subject requiring general anaesthesia or constant sedation.
6) Subject who is on treatment with Non-steroidal Anti-inflammatory Drugs (NSAIDs) except antiplatelet drugs (e.g. aspirin, clopidogrel).
Note: If the subject was on any of these drugs, sufficient washout period (of at least 5 half-lives) must have elapsed since the last dose of such drug before tooth extraction.
7) Subject who has known haemorrhagic diathesis.
8) Subject with anaemia (haemoglobin value < 10 g/dL), known liver disease or any medical condition which might affect the coagulation process.
9) Subject with a systolic blood pressure above 150 mmHg or a diastolic blood pressure above 100 mmHg.
Note: In case the subject has a blood pressure above the specified values, the subject will be rested for 15 minutes and a second blood pressure value will be obtained. The subject will be considered eligible only if the blood pressure values are within the specified limits.
10) Subject suffering from any psychiatric disease.
11) History of uncontrolled diabetes mellitus (HbA1c > 8%).
12) Subject suffering with any retinal pathology at the time of screening as per investigator discretion.
13) Subject who is undergoing tooth extraction due to trauma.
14) Subject who is known case of thyroid disorder.
15) Subject with known alcohol or drug abuse in the last 6 months. Alcohol abuse is defined as the consumption of more than 3 ounces (about 90 mL) of liquor or spirits or 18 ounces (about 530 mL) of beer per day, for 5 consecutive days during the 6-month period. Drug abuse is defined as the use of any recreational drug for 5 consecutive days during the 6-month period.
16) Smokers; defined as smoking more than 10 cigarettes per day.
17) Employee of the investigator, contract research organisation (CRO), Sponsor who is involved in the study, or an immediate family
members (e.g. partner, offspring, parents, siblings or sibling’s offspring) of an employee who is involved in the study.
18) Live in the same household as currently randomised subjects.
19) Subject who is currently participating in, or had in the 30 days prior to the study participated in an investigational study.
20) Subject with historical or current evidence of significant haematologic, hepatic, neurologic, renal, or other diseases that, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
21) Subject having any other clinically significant finding of the physical examination or laboratory value or any reason which in the
opinion of the investigator, would prevent the subject from safely participating in the study.
A Randomised, Double-blind, Multicenter, Placebo-controlled, Parallel study to Evaluate the Efficacy and Safety of Tranexamic Acid Mouthwash of Morningside Healthcare Limited, UK, to Reduce Bleeding in subjects undergoing Tooth Extraction who are on Drugs Affecting Hemostasis. Subjects who meet all criteria will be screened in the study. Total 728 subjects will be enrolled in order to complete the study with at least 582 evaluable subjects.
Subject will be instructed to take 10 ml of the assigned solution measured and keep the solution in the mouth for 2 minutes and then to gently drain the mouthwash from mouth, taking care not to rinse, gargle or forcibly spit the solution. Subjects will be given total 12 doses during the study. Primary endpoint will be number of oral bleeding events observed from Day 1 to Day 7. Secondary endpoint will be proportion of subjects with oral bleeding, bleeding score, Treatment-Emergent Adverse events (TEAEs) and serious adverse events (SAEs), non-oral bleeding, thrombotic events and local irritation related AEs etc.