| CTRI Number |
CTRI/2021/05/033728 [Registered on: 21/05/2021] Trial Registered Prospectively |
| Last Modified On: |
15/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of root resorption of mandibular anterior teeth at the end of post alignment stage with three different alignment archwires - A CBCT study |
|
Scientific Title of Study
|
Evaluation of root resorption of mandibular anterior teeth at the end of stage I with three different alignment archwires. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRYESASWINI GONUGUNTLA |
| Designation |
I MDS |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
Department of orthodontics and dentofacial orthopedics, room no: 06,
SIBAR institute of dental sciences
Takkellapadu, Guntur, Andhra pradesh -
Department of orthodontics and dentofacial orthopedics, room no:06,SIBAR institute of dental sciences
Takkellapadu, Guntur, Andhra pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8867837830 |
| Fax |
|
| Email |
yeseswini16696@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPRevathi |
| Designation |
professor and HOD Dpt of orthodontics |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
Department of orthodontics and dentofacial orthopaedics, room no: 06,SIBAR institute of dental sciences
Takkellapadu, Guntur, Andhra pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9848885654 |
| Fax |
|
| Email |
revathipeddu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAruna Dokku |
| Designation |
senior lecturer |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
Department of orthodontics and dentofacial orthopedics, room no: 06,SIBAR institute of dental sciences
Takkellapadu, Guntur, Andhra pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490833100 |
| Fax |
|
| Email |
aruna.chinni2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Gyesaswini |
| Address |
SIBAR institute of dental sciences |
| 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 |
| yesaswini |
Sibar institute of dental sciences. |
Department of orthodontics and dentofacial orthopedics, room no: 06.
Guntur
ANDHRA PRADESH |
8867837830
yeseswini16696@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ETHICAL Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (4) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (5) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (6) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alignment of mandibular arch using various Nickel titanium wires |
Each patient is randomly allocated to one of the 3 groups
Group I: Copper Ni-Ti 350 c; ORMCO, Medium force equivalent
Group II: Super elastic; 3M UNITEK, High force equivalent
Group III: Nitinol Classic; 3M UNITEK, Extreme force equivalent. Pretreatment cbct record of lower anteriors is taken followed by alignment stage.At the end of alignment stage post alignment cbct is taken. amount of root resorption taken place after post aignment is checked from the cbct records.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
• Patients with Angle class I malocclusion in permanent dentition.
• Dentoalveolar crowding with littles irregularity index of 6mm or more.
• Therapeutic extraction of all first premolars.
• Patients willing to participate in this treatment procedure will be included after taking informed consent for the same
|
|
| ExclusionCriteria |
| Details |
• Patients with systemic conditions and on continuous medication
• Traumatic injuries and dental restorations.
• Caries and periodontitis.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To measure root length and volume change from T0-T1 in Copper NiTi group.
2. To measure root length and volume change from T0-T1 in superelastic NiTi group.
3. To measure root length and volume change from T0-T1 in Nitinol group.
4. Comparison of T0-T1 between group I,II and III.
|
4 to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any difference in time of alignment between the three groups of wires |
4 to 6months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/06/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET SENT FOR ANY PUBLICATION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| this study is a randomized triple blinded study intended to evaluate the change in root length and rot volume from pretreatment to post alignment using three different alignment archwires. total sample size is 90, each group consisting of 30 patients 90 patients seeking orthodontic treatment will be selected for the study and randomly allocated into 3 groups (n: 30 per group) as follows. Care will be taken to match the demographics for the total sample. Group I: Copper Ni-Ti 350 c; ORMCO, Medium force equivalent Group II: Super elastic; 3M UNITEK, High force equivalent pretreatment and post alignment CBCT images for mandibular anterior teeth will be taken and used to evaluate the amount of root resorption Group III: Nitinol Classic; 3M UNITEK, Extreme force equivalent. | |