| CTRI Number |
CTRI/2022/12/048111 [Registered on: 14/12/2022] Trial Registered Prospectively |
| Last Modified On: |
13/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EVALUATION AND COMPARISON OF RATE OF CANINE RETRACTION USING PIEZOCISION AND MICRO OSTEOPERFORATION
A SPLIT MOUTH RANDOMIZED CONTROL TRIAL |
|
Scientific Title of Study
|
EVALUATION AND COMPARISON OF RATE OF ORTHODONTIC TOOTH MOVEMENT DURING CANINE RETRACTION USING PIEZOCISION AND MICRO-OSTEOPERFORATION – A SPLIT MOUTH RANDOMIZED CONTROL 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 Abhilash D |
| Designation |
MDS |
| Affiliation |
Vishnu dental college Bhimavram |
| Address |
D vara prasada rao
H no 16 24
Bhagath singh road
Chilakaluripet
Guntur District
D vara prasada rao
H no 16 24
Bhagath singh road
Chilakaluripet
Guntur District
West Godavari
ANDHRA PRADESH
522616
India |
| Phone |
7842301997 |
| Fax |
|
| Email |
drabhilashdara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen kumar varma |
| Designation |
MDS |
| Affiliation |
Vishnu dental college Bhimavram |
| Address |
Room no : 6
department of orthoontics and dentofacial orthopedics
vishnu dental college
Room no : 6
department of orthoontics and dentofacial orthopedics
vishnu dental college
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9701457533 |
| Fax |
|
| Email |
dpkvarma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilash D |
| Designation |
MDS |
| Affiliation |
Vishnu dental college Bhimavram |
| Address |
Room no : 6
department of orthoontics and dentofacial orthopedics
vishnu dental college
Dr Abhilash D
Post graduate
Department of orthodontics and dentofacial orthopedics
Vishnu dental college
Vishnupur
Bhimavaram 534202
West Godavari
ANDHRA PRADESH
522616
India |
| Phone |
7842301997 |
| Fax |
|
| Email |
drabhilashdara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 5
Department of orthodontics and dentofacial orthopedics
vishnu dental college
Vishnupur
Bhimavaram 534202 |
|
|
Primary Sponsor
|
| Name |
Dr Abhilash D |
| Address |
D vara prasada rao
H No 16 24
Bhagat singh road
Chilakaluripet
Guntur district |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Abhilash Dara |
vishnu dental college |
room no 6, department of orthodontics and dentofacial orthopedics,vishnu dental college,kovvada,bhimavaram
West Godavari
ANDHRA PRADESH |
7842301997
08816-250894
drabhilashdara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, VISHNU DENTAL COLLEGE, BHIMAVARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
accelarating orthodontic procedures
1.piezocision
2.microosteo-perforations |
piezocision/microosteoperforation done on experiment side at t0 baseline to assess the rate of canine retraction |
| Intervention |
accelerating orthodontic procedures |
microosteoperforation done on experiment side at t0 baseline to assess the rate of canine retraction |
| Comparator Agent |
contra lateral / non experimental / control side (split mouth) |
experimental side is compared with control side on the contralateral side of same patient (split mouth design
) |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Angles class I & class II division 1 malocclusion, requiring maxillary 1st premolar extraction on both sides and have completed leveling and alignment.
2.Age group between 13 to 25 years.
3.Completion of the eruption of permanent dentition(except 3rd molars)
|
|
| ExclusionCriteria |
| Details |
1.Patients have undergone previous orthodontic treatment.
2.Syndromic patients like cleft lip&palate.
3.Patients with poor oral hygiene.
4.Patients with any systemic diseases like Diabetes mellitus, bone disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rate of canine retraction
from baseline to 3rd time interval for every 28 days |
Baseline T0- day 1 before retraction
1st Time interval T1 - 28 days after retraction
2nd time interval T2 - 56days after retraction
3rd interval T3 - 84 days after retraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| External Apical root resorption |
t0 - 1st day and
t3 - 84th day |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
22/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/03/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
16 Patients with Angles class I & II will be included in the study. On right side of the upper jaw surgical slit preparation will be done using either piezocision technique piezotome or microosteoperforations using IDOdevice & tip. The other side of the upper jaw will be considered as a control site to assess the tooth movement. The procedure will be done under local anesthesia. Patient will be recalled for follow up on 1st ,2nd , 3rd months after the procedure to assess the rate of canine tooth movement using study models prepared by recording the impression and measurement of canine tooth root resorption using intra oral periapical radiographs. |