| CTRI Number |
CTRI/2024/07/070111 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of amount of two teeth space closure techniques |
|
Scientific Title of Study
|
Comparative Evaluation Of Rate Of Intrusion, Retraction And Amount Of Periapical Root Resorption With Jayades Intrusion Arch And Modified Three Piece Intrusion Arch Using Cone Beam Computed Tomography. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bulbul Baid |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
1st floor, 102 Department of orthodontics and Dentofacial facial Orthopedics, Sharad Pawar Dental College, and Hospital Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
09284384989 |
| Fax |
|
| Email |
baidbulbul6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Kamble |
| Designation |
Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
1st floor, 102 Department of orthodontics and Dentofacial facial Orthopedics, Sharad Pawar Dental College, and Hospital Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822231975 |
| Fax |
|
| Email |
ranjitkamble2506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjit Kamble |
| Designation |
Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
1st floor, 102 Department of orthodontics and Dentofacial facial Orthopedics, Sharad Pawar Dental College, and Hospital Sawangi Meghe Wardha 442001
MAHARASHTRA
442001
India |
| Phone |
9822231975 |
| Fax |
|
| Email |
ranjitkamble2506@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Bulbul Baid |
Sharad Pawar Dental College and Hospital |
1st floor, 102 Department of orthodontics and Dentofacial facial Orthopedics, Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA |
09284384989
baidbulbul6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K002||Abnormalities of size and form ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jayades Intrusion Arch |
After initial levelling and alignment, patients will be randomly allocated into two groups. Group A will be given Jayades Intrusion Arch for 2-6 months |
| Comparator Agent |
Modified Three Piece Intrusion Arch |
After initial levelling and alignment, patients will be randomly allocated into two groups. Group B patients will be given Modified Three Piece Intrusion Arch for 2-6 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients with greater overbite. (i.e., ≥5 mm).
Patients of post pubertal age
Patients of Class I,II overbite cases requiring extraction
|
|
| ExclusionCriteria |
| Details |
Patients exhibiting persistent or recurrent periodontal diseases
Patients presenting with any systemic disease.
Patients with a history of prior orthodontic treatment.
Patients with bone deformities.
Patients possessing malformed roots.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| rate of intrusion, retraction and amount of root resorption of Jayade and Modified Three Piece Intrusion arch will be evaluated and compared |
at 8 week, 16 week, 24 week after application of Jayades and Modified Three Piece intrusion arch |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION
Deep bite, a common orthodontic malocclusion, necessitates
timely intervention to prevent potential side effects. If left untreated, deep
bite can lead to increased tooth wear, dental injuries, and temporomandibular
joint disorders. Various treatment modalities, such as anterior teeth intrusion
and posterior teeth extrusion, are employed to correct deep bite. However,
selecting the optimal approach requires careful consideration of
patient-specific factors and treatment objectives. While anterior teeth intrusion
is effective for mild to moderate cases, posterior teeth extrusion may be
preferred in severe deep bite scenarios. There are various treatment modalities
for deep bite correction such as intrusion arches and mini screw implants.
AIM
“Comparative
evaluation of rate of intrusion, retraction and amount of periapical root
resorption with jayade’s intrusion arch and modified three piece intrusion arch
using cone beam computed tomography.â€
MATERIAL AND METHODS
This
prospective two arm parallel interventional study involving 20 patients selected
from Department of Orthodontics and Dentofacial Orthopaedics out patient
department. They will be split into 2 groups. The MBT
bracket system with triple tubes on maxillary teeth and a slot dimension
of.022" x.028" will be used to begin all cases. After initial alignment and levelling and extraction
as per the case then intrusion arch is given. Jayade’s intrusion arch will be given in group A, while Modified Three
Piece intrusion arch will be given in group B. The rate of intrusion,
retraction and amount of root resorption will be measured before initiation of
intrusive and retractive forces and at two, four, six months after application
of intrusive and retractive forces
RESULTS
AND CONCLUSION
This study will
determine the efficacy of simultaneous intrusion and retraction of Jayade’s
intrusion arch and Modified Three Piece Intrusion arch interrelated with amount
of root of resorption, thus weighing the better treatment modality for rectification
of deep bite. |