| CTRI Number |
CTRI/2024/10/074585 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the bleed control, antimicrobial and healing properties of 1 percent feracrylum in post dental extraction healing in medically compromised patients. |
|
Scientific Title of Study
|
Efficacy of haemostatic, hygroscopic and antimicrobial properties of 1 percent Feracrylum post dental extractions in medically compromised patients . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Sheshrao Bibe |
| Designation |
MDS - OMFS Postgraduation student |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of OMFS, Room no.5, Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Chennai.
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road,Maduravoyal, Chennai - 600095.
Thiruvallur
TAMIL NADU
600095
India |
| Phone |
8626078175 |
| Fax |
|
| Email |
vaibhavbibe10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Keerthana Ponvel |
| Designation |
Assistant Professor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of OMFS, Room no.5, Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Chennai.
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road,Maduravoyal, Chennai - 600095.
Thiruvallur
TAMIL NADU
600095
India |
| Phone |
9790885444 |
| Fax |
|
| Email |
drkeerthanaomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keerthana Ponvel |
| Designation |
Assistant Professor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of OMFS, Room no.5, Meenakshi Ammal Dental College and Hospital, Chennai
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road,Maduravoyal, Chennai - 600095.
Thiruvallur
TAMIL NADU
600095
India |
| Phone |
9790885444 |
| Fax |
|
| Email |
drkeerthanaomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Themis Medicare Limited,11/12, Udyog Nagar, S.V. Road, Goregaon West, Mumbai- 400104,India. |
|
|
Primary Sponsor
|
| Name |
Themis Medicare Ltd |
| Address |
Themis Medicare LTD, 11/12, Udyog nagar, S.V Road, Goregaon(W)- 400104 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vaibhav Sheshrao Bibe |
Meenakshi Ammal Dental College and Hospital |
Department of OMFS, Rom no. 5 ,Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai, 600095.
Thiruvallur
TAMIL NADU |
8626078175
vaibhavbibe10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Meenakshi Ammal Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% Feracrylum |
A gauze soaked in 2ml solution of 1% Feracrylum will be placed on the extraction socket for 10 mins after extraction followed by prescription of 1% Feracrylum mouthwash for next 7 days after extraction. |
| Comparator Agent |
Normal Saline |
A gauze soaked in 2ml of Normal saline will be placed on the extraction socket for 10 mins after extraction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for intra-alveolar extractions, systemic Diseases like hypertension and diabetes, patients on aspirin therapy, ASA 1 and 2. |
|
| ExclusionCriteria |
| Details |
Patients with AIDS or immunosuppressive diseases; pregnant or lactating women; patients allergic to lidocaine, paracetamol or ibuprofen; patients in whom the administration of epinephrine is contraindicated, patients who presented with a jawbone-associated pathology. and non-co-operative patients (psychic-motor dysfunction and behaviour disorders), ASA 3, 4 and 5. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Increase in rate and amount of wound closure.
2.Decrease incidence of post –op infections without the use of strong antibiotics.
3. Arrest of bleeding without any additional intervention. |
On the day of extraction.
1- 3rd day after extraction.
2- 7th day after extraction healing is best with feracrylum without any infection, and pain .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Increase in wound closure rate.
2.Decrease in chances of dry socket thus decrease in post operative pain.
3. Asepsis . |
72 hours after extraction
14 days post extraction |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
14/10/2024 |
| 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="6"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vaibhavbibe10@gmail.com].
- For how long will this data be available start date provided 03-10-2024 and end date provided 30-10-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study aims at evaluating the haemostatic,
hygroscopic and antimicrobial properties of 1% feracrylum in medically compromised
patients.
The prospective clinical trial will involve
patients of age 18-65 years
who are planned for intra-alveolar extractions and having systemic diseases
like hypertension and diabetes or on aspirin therapy. Divided into group A and
B Study group and Control group respectively.
After
the extraction of the tooth a gauze soaked with Themiseal 1% feracrylum will be
placed on the socket for 2 minutes, and amount of bleeding will be recorded by
removing the gauze and taking a photograph. Same gauze will be placed and as
did earlier and photos will be taken to record bleeding at 5 minutes
and 10 minutes after extraction. Following this, for initial
assessment of WOUND CLOSURE RATE parameter a photograph was taken after 30
minutes of extraction which will be the 1st record of the wound
size, proforma including all the necessary questionnaires, parameters and
patient’s details will be filled and patient will be prescribed with antibiotics, analgesics for next 3 days
and Themiseal mouthwash for next 7 days, In the control group the parameter
will be the same just guaze placed after extraction will be saline soaked gauze
and Themiseal mouthwash won’t be prescribed.
Recall of the patient will be done on 3rd,
7th and 15th day according to the study parameters which
are a) Post-operative bleeding scale. b) Wound healing status. c) Visual
Analogue Scale. d) Wound Closure Rate. e) Verbal rating scale. f) Asepsis wound
score. For both the groups. |