CTRI Number |
CTRI/2021/09/036859 [Registered on: 27/09/2021] Trial Registered Prospectively |
Last Modified On: |
11/01/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
clinical comparison of three new arch wires in mandibular anterior decrowding-A randomized controlled trial |
Scientific Title of Study
|
Clinical comparison of three aligning arch wires in relieving mandibular anterior crowding – A randomized controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Thrishna Ashok |
Designation |
post graduate |
Affiliation |
Sri Balaji Vidyapeeth |
Address |
Department of orthodontics and dentofacial orthopaedics
Indira Gandhi institute of dental sciences
Sri Balaji vidyapeeth pondicherry
Thejodhayam pykkat lane near GH mahe
Pondicherry PONDICHERRY 607402 India |
Phone |
9677417685 |
Fax |
|
Email |
drthrishnaashok@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pavithranand |
Designation |
Professor and Head |
Affiliation |
Sri Balaji Vidyapeeth |
Address |
Department of orthodontics and dentofacial orthopaedics
Indira Gandhi institute of dental sciences
Sri Balaji vidyapeeth pondicherry
Department of orthodontics and dentofacial orthopaedics
Indira Gandhi institute of dental sciences
Sri Balaji vidyapeeth pondicherry
Pondicherry PONDICHERRY 607402 India |
Phone |
9443183590 |
Fax |
|
Email |
pavithranandammayappan@igids.ac.in |
|
Details of Contact Person Public Query
|
Name |
Thrishna Ashok |
Designation |
post graduate |
Affiliation |
Sri Balaji Vidyapeeth |
Address |
Department of orthodontics and dentofacial orthopaedics
Indira Gandhi institute of dental sciences
Sri Balaji vidyapeeth pondicherry
Thejodhayam pykkat lane near GH mahe
PONDICHERRY 607402 India |
Phone |
9677417685 |
Fax |
|
Email |
drthrishnaashok@gmail.com |
|
Source of Monetary or Material Support
|
Department of Orthodontics
Indira Gandhi institute of dental sciences pondicherry |
|
Primary Sponsor
|
Name |
Thrishna Ashok |
Address |
Indira Gandhi institute of dental sciences pondicherry |
Type of Sponsor |
Other [post graduate] |
|
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 |
Thrishna Ashok |
Indira Gandhi institute of dental sciences pondicherry |
Indira Gandhi institute of dental sciences pondicherry Pondicherry PONDICHERRY |
9677417685
drthrishnaashok@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee Indira Gandhi institute of dental sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group 1: standard NiTi archwire |
After randomization and allocation of patients into group 1, Banding and bonding will be done with pre adjusted edge wise MBT brackets and arch wires will be inserted and ligated with 3M elastomeric modules. If debonding occurs during treatment, rebonding will be done within 24 hours; otherwise, it will be considered as dropout
At the routine follow-up appointment at 4 weeks, the wire will be removed and alginate impression has to be made. This alginate impression will then cast with stone. The archwires will be ligated and activated with elastomeric modules. The whole procedure has to be repeated again at every 4 weeks till decrowding occur. Little’s irregularity index will be measured at each appointment from the cast using a digital Vernier calliper These readings will be taken at 0-, 4-, 8-, and 12-week and will be designated as T0, T1, T2, T3 respectively. |
Intervention |
Group 2:Copper NiTi archwire |
After randomization and allocation of patients into group 2, Banding and bonding will be done with pre adjusted edge wise MBT brackets and arch wires will be inserted and ligated with 3M elastomeric modules. If debonding occurs during treatment, rebonding will be done within 24 hours; otherwise, it will be considered as dropout At the routine follow-up appointment at 4 weeks, the wire will be removed and alginate impression has to be made. This alginate impression will then cast with stone. The archwires will be ligated and activated with elastomeric modules. The whole procedure has to be repeated again at every 4 weeks till decrowding occur. Little’s irregularity index will be measured at each appointment from the cast using a digital Vernier calliper These readings will be taken at 0-, 4-, 8-, and 12-week and will be designated as T0, T1, T2, T3 respectively. |
Intervention |
Group 3: Smart archwire |
After randomization and allocation of patients into group 3, Banding and bonding will be done with pre adjusted edge wise MBT brackets and arch wires will be inserted and ligated with 3M elastomeric modules. If debonding occurs during treatment, rebonding will be done within 24 hours; otherwise, it will be considered as dropout At the routine follow-up appointment at 4 weeks, the wire will be removed and alginate impression has to be made. This alginate impression will then cast with stone. The archwires will be ligated and activated with elastomeric modules. The whole procedure has to be repeated again at every 4 weeks till decrowding occur. Little’s irregularity index will be measured at each appointment from the cast using a digital Vernier calliper These readings will be taken at 0-, 4-, 8-, and 12-week and will be designated as T0, T1, T2, T3 respectively. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
1. Age group above 18 years.
2. Eruption of mandibular teeth upto second molar.
3. Patient’s treatment plan which includes both non-extraction and therapeutic extraction of pre-molars.
4. Little irregularity index score more than 4. |
|
ExclusionCriteria |
Details |
1. Congenitally missing or impacted lower anterior teeth.
2. Periodontally compromised patients.
3. Treatment plan which included the use of intermaxillary elastic, interproximal stripping to relieve the crowding.
4. Previous history of active Orthodontic treatment
5. Patient with relevant medical history.
6. Patient with spacing in the lower anterior region
7. Patient allergic to nickel or other metal.
8. Treatment modality which include the placement of transpalatal arch or lingual arch which may cause discomfort.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Rate of decrowding of mandibular anteriors |
every 4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
time taken for mandibular anterior decrowding |
T0, and after total decrowding(T4 or T5) as assessed by the predetermined protocol |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="39" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
04/10/2021 |
Date of Study Completion (India) |
05/12/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Started with manuscript writing |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Contemporary orthodontic treatment involves use of both fixed and removable appliances. Alignment and levelling of teeth generally constitute the most important preliminary clinical phase of any orthodontic treatment with appliances. Levelling is the process in which incisal edges of anterior teeth and buccal cusps of posterior teeth are placed on same horizontal level and alignment is lining up of teeth of an arch in order to achieve normal contact point relationship. Process of levelling can be orthodontically preferred by means of different techniques. Fixed orthodontic appliance include a wide variety of arch wires used as a means of delivering forces on the teeth. Ideally arch wires are designed to move the teeth with light continuous forces, which reduce patient discomfort, tissue hyalinization and root resorption. The aligning arch wires are intended to be inserted into the fixed orthodontic appliance at the beginning of treatment, mainly to correct crowding and dental rotations. The success of the orthodontic treatment may depend on the selection of the aligning archwires. As there are a variety of available archwires, it is important to know which is the most efficient during the initial aligning stage of the treatment. In order for the orthodontist to select the most appropriate archwire, it is important to understand the optimal characteristics for all of the available archwires. Light and continuous forces are desirable to achieve physiologic tooth movement with minimum pathological effect on the teeth and their surrounding structures.1 Clinically, this means that we need the optimal force with which to produce the fastest tooth movement with the least root resorption and/or pain for the patient. The forces delivered by the archwires depend largely on the physical properties and dimensions of the wire material. An ideal aligning archwire should have a good formability, spring-back, stiffness biocompatibility, low friction, Join ability, and cost. The use of NiTi archwires in orthodontics was first described by Andreasen and Hilleman; these wires were manufactured as Nitinol wires. Since their introduction, wires made out of NiTi alloys have become an important part of orthodontic treatment. First NiTi alloy archwires were marketed by Unitek corporation who are now known as 3M Unitek. These alloys have low stiffness, superelasticity, high springback, large elastic range and were brittle.3 In 1994 Ormco corporation introduced Copper nickel titanium alloy. This alloy was developed with the help of Rohit Sachdeva and Suchio Miyaski. Initially, it was available in three temperature transition forms. Addition of copper leads to better defined transition temperature in this alloy. Smart archwire(S-A) is a new generation of multiforce archwire introduced recently that has differential superelastic properties based on advanced concepts in material science, and periodontal ligament physiology. These are laser conditioned CuNiTi wires with a differential force profile that is based on the optimal compressive stress in the periodontal ligament. Pandis et al clinically evaluated mandibular anterior crowding alleviation performed with CuNiTi and NiTi wires. Their results did not find significant differences between wires with regard to alignment efficiency and treatment duration. Moreover, a recent systematic review was unable to show which is the most effective archwire sequence for levelling and aligning the teeth, due to the lack of in vivo studies. Thus, it becomes necessary to compare the clinical performance of conventional alloys, such as standard NiTi and CuNiTi archwires with newer one such as the Smart archwire in regards to their alignment efficiency in crowded teeth.
AIM To compare the alignment efficiency of standard NiTi, CuNiTi with smart arch wire in relieving mandibular anterior crowding . OBJECTIVES • To evaluate the alignment efficiency of standard NiTi arch wire. • To evaluate the alilgnment efficiency of CuNiTi arch wire. • To evaluate the alignment efficiency of SMART ARCHWIRE. • To compare the alignment efficiency of SMART ARCHWIRE with standard NiTi and CuNiTi in relieving mandibular anterior crowding |