| 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
|
|
|
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
|
|
|
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. |