| CTRI Number |
CTRI/2022/11/047475 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Periotome in atraumatic extraction |
|
Scientific Title of Study
|
COMPARISON OF FLEXIBLE AND NON-FLEXIBLE CONVENTIONAL PERIOTOMES IN ATRAUMATIC EXTRACTIONS . A 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 |
Zoya rafiq |
| Designation |
Post graduate 2nd year |
| Affiliation |
Yenepoya university |
| Address |
15/4corniche manor chikka bazaar road cross Tasker town bangalore
Yenepoya University, University Road,Deralakatte, Mangalore, Karnataka 575018
Bangalore
KARNATAKA
560051
India |
| Phone |
07259194939 |
| Fax |
|
| Email |
10495.zoya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinayakrishna k |
| Designation |
Associate proffesor |
| Affiliation |
Yenepoya university |
| Address |
Yenepoya University, University Road,Deralakatte, Mangalore, Karnataka 575018
Yenepoya University, University Road,Deralakatte, Mangalore, Karnataka 575018
Bangalore
KARNATAKA
560051
India |
| Phone |
|
| Fax |
|
| Email |
DRVINNYKOLARI@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Zoya rafiq |
| Designation |
Post graduate 2nd year |
| Affiliation |
Yenepoya university |
| Address |
15/4corniche manor chikka bazaar road cross Tasker town bangalore
Yenepoya University, University Road,Deralakatte, Mangalore, Karnataka 575018
Bangalore
KARNATAKA
560051
India |
| Phone |
07259194939 |
| Fax |
|
| Email |
10495.zoya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
YENEPOYA UNIVERSITY |
| Address |
Yenepoya University, University Road,Deralakatte, Mangalore, Karnataka 575018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 vinayakrishna |
Yenepoya dental college |
ROOM NO 4 / DEPARTMENT OF ORAL SURGERY / YENEPOYA DENTAL COLLEGE Yenepoya university deflate 575018
Dakshina Kannada
KARNATAKA |
08242204668
drvinnykolari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional peritome |
GDC - PT1 type
use to severe the periodontal ligament while extractinng tooth |
| Intervention |
Instrument - Flexible peritome |
flexible peritome
GDC - type PFT1
use to severe the periodontal ligament while extractinng tooth
it has wider blades and shape mmemory compared to orignal instrument of the same make |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral teeth needing atraumatic extractions for orthodontics or implant placement |
|
| ExclusionCriteria |
| Details |
Pregnancy, systemic diasease , drug allergy |
|
|
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 |
| TIME TAKEN FOR EXTRACTIONS |
1 DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEALING OF EXTRACTION SOCKET |
7TH DAY |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/11/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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 - 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 - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 06-05-2022 and end date provided 06-05-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Aim : To compare the efficiency of flexible periotome versus non flexible conventional periotome in atraumatic dental extraction of similar teeth Objectives : • To compare the wound healing following the use of flexible periotome and non flexible conventional peritome. • To compare the duration of procedure of flexible periotome and non flexible conventional periotome for extraction of tooth • To compare the level of gingival laceration in the use of flexible periotome and non flexible conventional periotome
6.1 . Study design: Randomised controlled trial
6.2 Study setting : â— The study will be conducted on patients visiting the DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, YENEPOYA DENTAL COLLEGE, Mangalore, Karnataka.
6.3 Source of data/sampling method : â— The study will be conducted on patients visiting the DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, YENEPOYA DENTAL COLLEGE, Mangalore, Karnataka. â— Convenience sampling will be used .
6.4 Sample size (including sample size calculation): Based on a previous study conducted , the effective size computed from this study is 80 % The sample size for the study was computed using G* power . For 80 % Power to determine the efficiency of flexible Periotome vs Periotome in atraumatic dental extraction of teeth at 5 % level the study requires 52 extractions. The sample size is 52 26 – Control group 26 – Study group
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