| CTRI Number |
CTRI/2020/06/026019 [Registered on: 22/06/2020] Trial Registered Prospectively |
| Last Modified On: |
16/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial to study the effect of a combination of propolis, vitamin C and vitamin E on the wound healing after wisdom tooth surgery. |
|
Scientific Title of Study
|
A Comparative evaluation of the effectiveness of combination of propolis, nano vitamin C and vitamin E with systemic antibiotics after impacted mandibular third molar surgery among 18-45 year old adults- A split mouth cross over randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KARISHMA MOTWANI |
| Designation |
POST GRADUATE |
| Affiliation |
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT NO.2 OF ORAL AND MAXILLOFACIAL SURGERY,
SECTOR 4, INSTITUTIONAL AREA,
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI
Mumbai
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
karishma.motwani05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHREYAS GUPTE |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT NO.2 OF ORAL AND MAXILLOFACIAL SURGERY,
SECTOR 4, INSTITUTIONAL AREA,
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
gshreyas@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KARISHMA MOTWANI |
| Designation |
POST GRADUATE |
| Affiliation |
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT NO.2 OF ORAL AND MAXILLOFACIAL SURGERY,
SECTOR 4, INSTITUTIONAL AREA,
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL, KHARGHAR, NAVI MUMBAI
Mumbai
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
karishma.motwani05@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF
Department No.2 Oral and Maxillofacial Surgery
Dr GD Pol Foundation’s YMT Dental College and Hospital, Kharghar
Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
DR KARISHMA MOTWANI |
| Address |
11/SAMARTH NIWAS
TEJPAL SCHEME ROAD NO. 4
VILE PARLE - EAST
MUMBAI - 400057 |
| Type of Sponsor |
Other [SELF] |
|
|
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 KARISHMA MOTWANI |
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT NO.2 OF ORAL AND MAXILLOFACIAL SURGERY,
Raigarh
MAHARASHTRA |
9820398688
karishma.motwani05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOCOMPATIBLE GEL CONTAINING PROPOLIS, VITAMIN C AND VITAMIN E |
ATRAUMATIC SURGICAL EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR FOLLOWED BY INTRA-ALVEOLAR PLACEMENT OF AN ABSORBABLE GELATIN FOAM IMPREGNATED WITH BIOCOMPATIBLE GEL CONTAINING A NANO-EMULSION OF PROPOLIS, VITAMIN C AND VITAMIN E FOLLOWED BY PRIMARY WOUND CLOSURE
DOSE- 10 MLOF GEL
FREQUENCY- ONCE
ROUTE- IN EXTRACTION SOCKET I.E INTRA-ALVEOLAR
TOTAL DURATION OF THERAPY- AROUND 1 AND HALF MONTH |
| Comparator Agent |
PLAIN ABSORBALE GELATIN FOAM |
ATRAUMATIC SURGICAL EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR FOLLOWED BY INTRA- ALVEOLAR PLACEMENT OF ABSORBALE GELATIN FOAM AND PRIMARY WOUND CLOSURE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)patients being 18 to 30 years of age with an indication for bilateral extraction of impacted mandibular third molars. The surgery difficulty index to range preferably between 7 and 10 according to the Pederson scale (being equal on both sides).
2)Good physical status (ASA Status I and II)
3)surgery completed within 30 minutes
4)absence of infection - local and systemic
5) no antibiotics and analgesics consumed 7 days prior to surgery
6)consenting patients to undergo procedure and follow up post-operatively. |
|
| ExclusionCriteria |
| Details |
1) Known systemic disease like diabetes, hypertension, thyroid disorders, etc
2)febrile patients with infection
3)Known drug and food allergies
4)Pregnancy and lactation
5)patients taking antipsychotic, sedatives, anti-coagulants,etc
6)Immunosuppresion
7)Pain of odontogenic origin, oral ulcers, cysts |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wound healing to be seen on 1st and 3rd operative day.
Presence or absence of dry socket to be detected. |
Wound healing to be seen on 1st and 3rd operative day.
Presence or absence of dry socket to be detected. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain to be evaluated on Visual Analogue Scale of 0-10 where 0 is no pain and a score of 10 is intolerable pain
|
1st and 3rd post-operative day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY AIMS TO EVALUATE THE EFFECTIVENESS OF A BIO-COMPATIBLE, BIO-OCCLUSIVE GEL CONTAINING A NANO-EMULSION OF PROPOLIS, VITAMIN C AND VITAMIN E AFTER IMPACTED MANDIBULAR THIRD MOLAR SURGERY. 40 SUBJECTS SELECTED ACCORDING TO INCLUSION AND EXCLUSION CRITERIA, WILL BE RANDOMLY ASSIGNED USING THE LOTTERY METHOD TO THE INTERVENTION GROUP WHEREIN THEY WILL UNDERGO AN ATRAUMATIC SURGICAL EXTRACTION OF MANDIBULAR IMPACTED THIRD MOLAR. THE EXTRACTION WOUND WILL BE DEBRIDED AND PLACED WITH AN ABSORBABLE GELATIN FOAM IMPREGNATED WITH THE INTERVENTION GEL AND CLOSED PRIMARILY. THE COMPARATOR GROUP AFTER A WASH OUT PERIOD OF 2 WEEKS WILL UNDERGO IMPACTED MANDIBULAR THIRD MOLAR SURGERY ON THE CONTRA-LATERAL SIDE FOLLOWED BY INTRA-ALVEOLAR PLACEMENT OF PLAIN ABSORBABLE GELATIN FOAM AND WOUND WILL BE SUTURED. THE PRIMARY OUTCOME IS THE WOUND HEALING TO BE ASSESSED CLINICALLY ON POST-OPERATIVE DAY 1 AND 3 AND NOTED DOWN USING A WOUND HEALING INDEX.THE SECONDARY OUTCOME WILL BE THE PAIN ASSESSMENT ON VISUAL ANALOGUE SCALE OF 0-10. 0 IS A SCORE OF NO PAIN AND 10 IS A SCORE OF INTOLERABLE PAIN. |