| CTRI Number |
CTRI/2024/06/069368 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Compare the effect of Laser on intrusion of maxillary incisors
using utility arch |
|
Scientific Title of Study
|
Effect of Utility Arch on Intrusion of Maxillary Incisors for Correction of Deep Bite in Adult Patient with and without Low-Intensity laser therapy: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Sunil Zanwar |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
104, Department of Orthodontics, Government Dental College and Hospital, Medical Campus, Medical Chowk, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8830642823 |
| Fax |
|
| Email |
vaibhavzawar6600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh J Chavan |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
104, Department of Orthodontics, Government Dental College and Hospital, Medical Campus, Medical Chowk, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9823630486 |
| Fax |
|
| Email |
drsjchavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh J Chavan |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
104, Department of Orthodontics, Government Dental College and Hospital, Medical Campus, Medical Chowk, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9823630486 |
| Fax |
|
| Email |
drsjchavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics & Dentofacial Orthopaedics, Government Dental College and
Hospital Nagpur, Medical College Premises, Medical Square, Nagpur, Maharashtra 440003 |
|
|
Primary Sponsor
|
| Name |
Vaibhav Sunil Zanwar |
| Address |
104, Department of Orthodontics, Government Dental College and Hospital, Medical Campus, Medical Chowk, Nagpur |
| Type of Sponsor |
Other [(Self Funded)] |
|
|
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 Vaibhav Sunil Zanwar |
Government Dental College and Hospital, |
Department of
Orthodontics &
Dentofacial
Orthopaedics,
Government Dental
College and Hospital
Nagpur, Medical
College Premises,
Medical Square,
Nagpur, Maharashtra
440003
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
8830642823
vaibhavzawar6600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College, Institutional Ethics Committee, Nagpur |
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 |
| Comparator Agent |
Conventional intrusion using utility arch. |
After taking signed consent form from patient and After analysis of the case –
Separators will be placed mesial and distal to first molars for the band placement.
After 2 days of separator placement, molar bands will be customized. Double molar tubes will be welded on buccal surface of maxillary molar bands.Preadjusted edgewise MBT brackets (ORTHO R Organizers, USA) of 0.022†slot will be bonded to the upper incisors.
Initial phase of segmental alignment and levelling will be initiated using 0.016â€, 0.016†x 0.022†heat activated nickel-titanium archwires (G&H, Orthoforce, USA).
After completion of segmental levelling, a custom-made maxillary utility arch 0.017 x 0.025 TMA (CHARLES B. SCHWED Co, New York) will be inserted for incisor intrusion. The utility arch will be sleeved to prevent any tissue irritation. It will be cinched back to prevent incisor proclination. It will be activated by giving tip back bend.Anchorage to maxillary molar will be provided by Trans Palatal Arch.The intrusive force will be checked before tying the archwire, and the force levels will be checked every 4 weeks till the normal overbite is achieved. |
| Intervention |
Low intensity laser therapy assisted intrusion using utility arch. |
After taking signed consent form from patient and After analysis of the case –
Separators will be placed mesial and distal to first molars for the band placement.
After 2 days of separator placement, molar bands will be customized. Double molar tubes will be welded on buccal surface of maxillary molar bands.Preadjusted edgewise MBT brackets (ORTHO R Organizers, USA) of 0.022†slot will be bonded to the upper incisors.
Initial phase of segmental alignment and levelling will be initiated using 0.016â€, 0.016†x 0.022†heat activated nickel-titanium archwires (G&H, Orthoforce, USA).
After completion of segmental levelling, a custom-made maxillary utility arch 0.017 x 0.025 TMA (CHARLES B. SCHWED Co, New York) will be inserted for incisor intrusion. The utility arch will be sleeved to prevent any tissue irritation. It will be cinched back to prevent incisor proclination. It will be activated by giving tip back bend.Anchorage to maxillary molar will be provided by Trans Palatal Arch.The intrusive force will be checked before tying the archwire, and the force levels will be checked every 4 weeks.The laser will be applied on the first day of the upper incisor intrusion (T0), then on days 3, 7, and 14 of the first month. In the second month, the laser will be applied every 15 days. Utility Arch will be checked regularly and at the end of 2nd month(T1) till the end of the intrusion stage (T2), which will be determined by reaching a normal overbite.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18 and 30 years, Overbite greater than 4 mm, Maxillary anterior crowding less than 2mm, Maxillary incisors positioned below the functional occlusal plane, Incisor display of 3 mm or more at rest, The facial growth pattern is average.
|
|
| ExclusionCriteria |
| Details |
Orthognathic surgery as treatment plan, Previous history of Root canal treatment with Incisors, History of systemic illness (systemic illnesses primarily affecting the calcium metabolism, or any other due to which the patient might be on any medication which may alter the rate of tooth movement), Periodontally compromised dentition, Previous history of orthodontic therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate of intrusion of maxillary incisors using Utility arch with or without LILT. |
T0 – Before the commencement of intrusion
T1 – At 2nd month of intrusion
T2- At the completion of intrusion
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the rate of intrusion of maxillary incisors using Utility arch with LILT.
To assess the rate of intrusion of maxillary incisors using Utility arch without LILT.
|
T0 – Before the commencement of intrusion
T1 – At 2nd month of intrusion
T2- At the completion of intrusion
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
03/07/2024 |
| 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="6"
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
|
An increased overbite can be seen with almost all malocclusions. The treatment of deep bite is one of the priorities of the orthodontist because of the potential negative effects deep bite can have on the teeth and their supporting periodontal tissues. Which can be corrected by intrusion of maxillary anteriors. Conventional methods of incisor intrusion usually involve appliances such as utility arches, 3-piece intrusion arches, or reverse curved arches. non-surgical methods that has the ability to accelerate the overall tooth movement is low intensity laser therapy (LILT), also known as low level laser therapy (LLLT). Effect of LILT on rate of OTM has been evaluated during canine retraction and during levelling and alignment , however fewer literature is available on effect of LILT on intrusion of maxillary anteriors. The aim of study is to determine the effect of LILT on rate of intrusion of maxillary incisors for correction of deep bite using Utility Arch. |