| CTRI Number |
CTRI/2022/01/039413 [Registered on: 13/01/2022] Trial Registered Prospectively |
| Last Modified On: |
30/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of turmeric gel insoft tissue healing of lower mandibular molar extraction socket |
|
Scientific Title of Study
|
Evaluation of healing in mandibular molar extraction sockets with and without turmeric gel |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreya Jeetendra Raut |
| Designation |
Postgraduate |
| Affiliation |
Dr. D.Y. Patil Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial surgery, Sant. Tukaram nagar, Pimpri ,Pune
Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar,Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8779245690 |
| Fax |
|
| Email |
shreyaraut324@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Shetty |
| Designation |
Professor and Guide |
| Affiliation |
Dr. D.Y. Patil Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial surgery, Sant. Tukaram nagar, Pimpri ,Pune
Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar,Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673006494 |
| Fax |
|
| Email |
drlakshmishetty21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Jeetendra Raut |
| Designation |
Postgraduate |
| Affiliation |
Dr. D.Y. Patil Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial surgery, Sant. Tukaram nagar, Pimpri ,Pune
Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar,Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8779245690 |
| Fax |
|
| Email |
shreyaraut324@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil Dental College and Hospital,Sant Tukaram Nagar, Pimpri,Pune |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Jeetendra Raut |
| Address |
Dr. D.Y. Patil Dental College and Hospital,Sant Tukaram Nagar, Pimpri,Pune |
| 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 Shreya Jeetendra Raut |
Department of Oral and Maxillofacial surgery |
Dr. D.Y. Patil Dental College and Hospital,Sant Tukaram Nagar, Pimpri,Pune
Pune
MAHARASHTRA |
8779245690
shreyaraut324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Dr. D.Y. Patil Vidyapeeth, Pune |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Placing turmeric gel in mandibular molar extraction socket | (Procedure Reference: Post operative healing of soft tissue after extraction, Procedure details: Turmeric gel preparation Th sample turmeric gel is yellowish in colour with pleasant odor and semisold state. It is consistent with 5.86 pH, Viscosity at 30 RPM is 536 while at 60 RPM it is 416. The gel is prepared using turmeric.Turmeric in gel form 20 % & water base gel 20% concentration.The gel is prepared by Dr. D.Y. Patil College of Ayurveda & Research Centre, Pimpri, Pune.
2ml of turmeric gel will be placed into extraction socket.
The frequency of the therapy will be once means turmeric)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who fit the inclusion criteria were patients between the age group of 18-50 years of age, bilateral mandibular molars indicated for extraction which cannot be saved by endodontic treatment and patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients who do not fit the exclusion criteria were patients not willing to follow up, pregnancy, patient with systemic diseases, patients whose mandibular molars were associated with any lesion and any contraindication for extraction under local anesthesia. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study evaluates soft tissue healing in mandibular molar extraction sockets with and without turmeric gel.
Experimental side and control side of the same patient were evaluated for soft tissue healing on postoperative day 1, day7 and day 21 using Landry, Turn Bell and Howley scale
Parameters for soft tissue using Landry, Turn Bell and Howley scale
Tissue colour
presence or absence of edema
responnse to palpation
Granulation tissue
incision margin
suppuration present or absent |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2022 |
| Date of Study Completion (India) |
15/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
National Journal of Oral and Maxillofacial surgery |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response (Others) - NIL
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shreyaraut324@gmail.com].
- For how long will this data be available start date provided 05-01-2022 and end date provided 05-05-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study evaluates soft tissue healing in mandibular molar extraction sockets with and without turmeric gel.50 patients were included in the study which were divided into group A, 25 into experimental sites using turmeric gel and group B, 25 into control sites using gelfoam in same patients. Experimental site and control site of the same patient was evaluated for soft tissue healing on postoperative day 1, day7 and day 21 using Landry, Turn Bell and Howley scale. |