| CTRI Number |
CTRI/2019/06/019597 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
06/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare the increase in length of the upper jaw with or without bone support in patients with one side split lip and palate using 3D x-ray |
|
Scientific Title of Study
|
Comparative evaluation of maxillary protraction with and without skeletal anchorage in patients with unilateral cleft lip and palate using CBCT: A clinical prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shuvadeep Dutta |
| Designation |
Post graduate student |
| Affiliation |
Institude of Dental Studies and Technologies |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room No - 4, Idst
N.H. 58, Delhi-Meerut Road, Kadrabad, Modinagar, Ghaziabad, Uttar Pradesh - 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8638581576 |
| Fax |
|
| Email |
shuvadeep.dutta05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Batra |
| Designation |
Head of Department |
| Affiliation |
Institude of Dental Studies and Technologies |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room No - 4, Idst
N.H. 58, Delhi-Meerut Road, Kadrabad, Modinagar, Ghaziabad, Uttar Pradesh - 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Batra |
| Designation |
Post graduate student |
| Affiliation |
Institude of Dental Studies and Technologies |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room No - 4, Idst
N.H. 58, Delhi-Meerut Road, Kadrabad, Modinagar, Ghaziabad, Uttar Pradesh - 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
09810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Shuvadeep Dutta, Department of Orthodontics and Dentofacial Orthopedics, Room no- 4, IDST, Modinagar, U.P.- 201201 |
|
|
Primary Sponsor
|
| Name |
Dr Shuvadeep Dutta |
| Address |
P.O.Collegenagar, North Guwahati, Kamrup, Assam - 781031 |
| 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 Shuvadeep Dutta |
Insttude of Dental Studies And Technologies |
Department of Orthodontics and Dentofacial Orthopedics, Room no- 4, IDST, N.H. 58, Delhi Meerut-Road,Kadrabad, Modinagar
Ghaziabad
UTTAR PRADESH |
8638581576
shuvadeep.dutta05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IERBC, IDST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q375||Cleft hard and soft palate with unilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Maxillary length |
The maxillary length obtained after protraction with tooth borne facemask and facemask with miniplates for 9-18 months |
| Intervention |
Maxillary protraction with and without skeletal anchorage |
Protraction of maxilla with tooth-borne facemask and facemask with miniplates for 9-18 months |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Unrepaired unilateral cleft lip and palate
2. GOSLON Yardstick Index: 3-4 |
|
| ExclusionCriteria |
| Details |
1. Any patient with associated syndromes
2. Unrepaired unilateral cleft lip and palate
3. Patients with incomplte clefts
4. Secondary alveolar bone grafted patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maxillary length |
9 - 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Positive overjet of 2-3 mm |
9 - 18 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/06/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
To increase the maxillary length and obtain a positive 2-3 mm overjet after maxillary protraction. To compare the amount of orthopedic and orthodontic effect in antero-posterior dimension, vertical dimention following maxillary protraction in repaired unilateral cleft lip and palate patients with facemask with miniplates and toothborne facemask therapy. |