| CTRI Number |
CTRI/2024/03/063875 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bone deposition and resorption in responds to pulling back of teeth in orthodontic extraction patient |
|
Scientific Title of Study
|
Cortical Bone Remodelling Response to Maxillary Incisor Retraction in Orthodontic Extraction Patients: A Cone Beam Computed Tomography Study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angousana Arambam |
| Designation |
post gratuate |
| Affiliation |
Rjasthan University of Health Science |
| Address |
Department of orthodontic and dentofacial orthopedic, room number 3, Surendera dental college and research institute, HH garden ,power house road
Ganganagar RAJASTHAN 335001 India |
| Phone |
09863253542 |
| Fax |
|
| Email |
angouarambamz@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Eenal Bhambri |
| Designation |
professor and head |
| Affiliation |
Rajasthan University and Health Science |
| Address |
Surendera Dental College and Research Institute HH Gardens, power house road, Sri Ganganagar Surendera Dental College and Research Institute HH Gardens, power house road, Sri Ganganagar Rajasthan 335001 Ganganagar RAJASTHAN 335001 India |
| Phone |
8769829700 |
| Fax |
|
| Email |
dreenal700@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Angousana Arambam |
| Designation |
post gratuate |
| Affiliation |
Rajasthan University and Health Science |
| Address |
department of orthodontic and dentofacial orthopedic ,room number 3,surendera dental college and research institute, HH garden ,power house road
Ganganagar RAJASTHAN 335001 India |
| Phone |
09863253542 |
| Fax |
|
| Email |
angouarambamz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Orthodontic and Dentofacial Orthopedic Surendera Dental College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Angousana Arambam |
| Address |
Surendera Dental College and Research Institute H.H Garden ,Power House Road,Sri Ganganagar , Rajasthan 335001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANGOUSANA ARAMBAM |
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
Department of orthodontics and dentofacial orthopedics ,surendera dental college HH Gardens, power house road, Sri Ganganagar 335001 Ganganagar RAJASTHAN |
09863253542
angouarambamz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETICAL COMMITTEE SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PATIENT OPTING REGULAR ORTHODONTIC TREATMENT |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
• Patients whose age range is 15-25 years.
• Patients with bimaxillary dentoalveolar protrusion or Angle’s class II division 1 malocclusion requiring extraction of 1st premolar.
• Maximum to moderate anchorage cases will be considered.
• The removal of bilateral maxillary first premolars during the orthodontic treatment followed by en masse retraction.
• No evidence of periodontal or gingival problems at the beginning of orthodontic treatment
• No history of trauma to the maxillary and mandibular anterior teeth.
• Good general and oral health and no use of anti-inflammatory drugs for at least 6 months before or during orthodontic treatment.
• Pretreatment (T0) and posttreatment (T1) CBCT scans
|
|
| ExclusionCriteria |
| Details |
• Root length (the distance from the cementoenamel junction to apex) of maxillary incisors was <9 mm in T0 CBCT, and
• Low CBCT image quality, the cortical bone and root could not be defined accurately.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the cortical bone remodelling after retraction of maxillary central incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary lateral incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary canine in orthodontic treatment.
To evaluate the efficacy of CBCT in detection of bone remodelling and tooth movement in pre-retraction and post retraction.
|
baseline and at six months
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To check the cortical bone remodelling after retraction of maxillary central incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary lateral incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary canine in orthodontic treatment.
To evaluate the efficacy of CBCT in detection of bone remodelling & tooth movement in pre-retraction & post retraction. |
baseline & at six months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="1" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
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Brief Summary
|
AIM:
To explore the
labial and palatal cortical bone remodelling and tooth movement measured at
different root levels of retracted maxillary incisors.
7 OBJECTIVES:
1)
To check the cortical bone
remodelling after retraction of maxillary central incisors in orthodontic treatment.
2)
To check the cortical bone
remodelling after retraction of maxillary lateral incisors in orthodontic
treatment.
3)
To check the cortical bone
remodelling after retraction of maxillary canine in orthodontic treatment.
4)
To evaluate the efficacy of
CBCT in detection of bone remodelling and tooth movement in pre-retraction and post
retraction. Materials: In this study, following armamentarium will be required
·
CBCT scans (Vatech A-9 machine). m METHODLOGY Apart from routine radiographs,
pretreatment CBCT scan will be taken for all subjects. All the selected subjects
will require bilateral extraction of premolars. Orthodontic treatment protocol
for all the patients will be bonding with metal
MBT(Leone) prescription of 0.022-
0.028 inch and transbond XT.
All the indicated first premolars will be extracted and alignment and levelling
will be performed using 0.014-0.016-inch NiTi arch wires. This will progress to
0.019-0.025-inch
stainless steel wires and en-masse retraction of
maxillary anterior teeth will
be performed using sliding mechanics.
The six maxillary anterior teeth will be consolidated by the figure of 8
ligatures and NiTi closed coil springs of either 9 or12 mm length will be used
from canine to molar to retract the maxillary anterior with a constant force of
150 g on both sides. Post retraction CBCT (T1) scan will
be taken for maxillary anterior (including canines) of all the subjects. The T0 and T1 CBCT
scans will be opened in WinRAR Software version 6.24; Vatech A-9 machine and
the slices (T0) will be used to outline the buccolingual border of the alveolar
bone and incisor edge. The sketch and slice (T1) will be merged into 1 CBCT image,
and the crestal (S1), midroot (S2), and apical (S3) level reference lines will
be marked and saved in jpeg format To measure the
position changes in the labial and palatal root and alveolar bone in the CBCT images,
each tooth will be measured at S1, S2, and S3 levels from the cementoenamel
junction every 3mm along the axis of the incisor. The following measurements will
be obtained (1) alveolar BR, which is the horizontal distance between labial or
palatal alveolar bone on T0 and T1 scans; (2) TM, defined as the horizontal
distance the labial or palatal borders of the incisor root on T0 and T1 scans;
(3) the BT ratio, defined as BR divided by TM; and (4) incisor movement pattern
(IMP) representing the retraction type of incisors, which is defined as TM(S3)/
TM (S1).demonstrate the
features of palatal BR more clearly, all patients will be classified according
to whether the root penetrated the original cortical bone border and whether BR
will be detected.
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