FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/063198 [Registered on: 27/02/2024] Trial Registered Prospectively
Last Modified On: 17/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry
Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Formulate and evaluate a gel which improves healing of tooth extraction wounds in diabetic patients. 
Scientific Title of Study   Formulation and evaluation of a gel comprising an antifibrinolytic (Tranexamic Acid) in combination with an antibiotic (Doxycycline) after tooth extraction in diabetic patients - A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR G ANAND 
Designation  JUNIOR RESIDENT 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, PD MELLO ROAD, FORT, MUMBAI

Mumbai
MAHARASHTRA
400001
India 
Phone  08807923820  
Fax    
Email  anandsmash98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. KAVITA WADDE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, PD MELLO ROAD, FORT, MUMBAI

Mumbai
MAHARASHTRA
400001
India 
Phone  09004799405  
Fax    
Email  dr.kavitawadde@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR G ANAND 
Designation  JUNIOR RESIDENT 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, PD MELLO ROAD, FORT, MUMBAI

Mumbai
MAHARASHTRA
400001
India 
Phone  08807923820  
Fax    
Email  anandsmash98@gmail.com  
 
Source of Monetary or Material Support  
Dr. Kavita Wadde Professor and Head, Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Mumbai 
Dr.Vandana Sanjeev Panda Prin. K. M. Kundnani College of Pharmacy, Plot No.23,Jote joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai-400005. 
Government Dental College and Hospital, Mumbai - 400001 
SIMRAN SONE Prin. K. M. Kundnani College of Pharmacy, Plot No.23,Jote joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai-400005 
 
Primary Sponsor  
Name  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MUMBAI 
Address  PD MELLO ROAD, FORT, MUMBAI 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR G ANAND  Government Dental College and Hospital  ROOM NO 118, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, PD MELLO ROAD, FORT, MUMBAI
Mumbai
MAHARASHTRA 
08807923820

anandsmash98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOVERNMENT DENTAL COLLEGE AND HOSPITAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PLACEBO GEL  Carbopol 971PNF – gelling agent Glycerin – solvent Propyl paraben – preservative Sodium hydroxide (10%) – pH adjuster Distilled water – vehicle Gel will be applied in the extraction socket immediately after tooth extraction and sutures will be placed. Patient will be evaluated for pain, swelling and trismus after first day, third day and seventh day after tooth extraction.  
Intervention  TRANEXAMIC ACID AND DOXYCYCLINE GEL  Tranexamic acid (5%) - antifibrinolytic agent Doxycycline (3%) – antibiotic Carbopol 971PNF – gelling agent Glycerin – solvent Propyl paraben – preservative Sodium hydroxide (10%) – pH adjuster Distilled water – vehicle Gel will be applied in the extraction socket immediately after tooth extraction and sutures will be placed. Patient will be evaluated for pain, swelling and trismus after first day, third day and seventh day after tooth extraction.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with known history of diabetes whose random blood sugar is within the normal limits.
Patients who are willing for treatment.
Patients who are willing to give consent to participate in the study.
Patients with no significant medical history. (ASA I and ASA II).
 
 
ExclusionCriteria 
Details  Patients with significant infections were excluded from this study.
Patients who are not willing for treatment.
Patients who are not willing to give consent to participate in the study.
Patients with significant medical history (ASA III and ASA IV).
Pregnant and lactating patient.
Patient having history of allergies to any medications.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate the wound healing activity of a gel comprising tranexamic acid and doxycycline after tooth extraction in diabetic patients  on the day of tooth extraction, 3rd day, 7th day and one month 
 
Secondary Outcome  
Outcome  TimePoints 
evaluation the efficacy of the gel in prevention of dry socket after tooth extraction in diabetic patients.
evaluation of the role of the gel in reduction of trismus after tooth extraction in diabetic patients.
evaluate whether the gel reduces incidence of infection after tooth extraction in diabetic patients.
evaluate whether the gel reduces incidence of pain after tooth extraction in diabetic patients.
 
evaluation the efficacy of the gel in prevention of dry socket after tooth extraction in diabetic patients.
evaluation of the role of the gel in reduction of trismus after tooth extraction in diabetic patients.
evaluate whether the gel reduces incidence of infection after tooth extraction in diabetic patients.
evaluate whether the gel reduces incidence of pain after tooth extraction in diabetic patients.
 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   18/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Now a days oral health play’s major important role in overall health, well-being, and quality of life which is mainly concerned with teeth, gums, and mouth. Dental disorders have become a major issue of concern now-a-days. Wound healing is a difficult procedure that requires both repair of the wound and the restoration of the damaged tissue. The procedure can be divided into the following stages: Formation of a blood clot, Inflammation, Formation of granulation tissue, Epithelialization, Bone formation, and re-modelling. During the healing oral wounds, diabetic individuals may encounter some problems. Diabetes can interfere with the body’s normal healing processes, making it more difficult for wounds to mend completely. The present study is a comparative evaluation of a novel combination of tranexamic acid and doxycycline in a gel for local drug delivery in wound healing after tooth extraction in diabetic patients. Patients will be selected based on the inclusion criteria by first co-investigator. All the information about the study will be revealed to the patient in the language he/she understands prior to surgery (Annexure ‘A’). Helsinki declaration consent (informed written consent) forms will be signed by patients and or/or parents according to Annexure ‘C’ after receiving a detailed explanation about the experimental rationale, therapy, and possible risks associated with the treatment & study in the language (in English, Hindi, Marathi) that he/she understands. A detailed case history will be taken for all patients (Annexure ‘B’), followed by clinical examination. Fitness certificate if required will be taken from general physician, general surgeon or neurosurgeon. After extraction of the tooth the gel containing doxycycline and tranexamic acid will be given to group A patients and gel containing placebo will be given to group B patients into the socket and suturing will be done with 3-0 black silk suture and pressure pack will be given followed by post operative instructions. Patients will be recalled on intervals of day-3 and day-7 evaluated for pain, mouth opening, swelling, incidence of dry socket and saliva samples will be collected for biochemical evaluation and day 15 for wound healing.

 
Close