| CTRI Number |
CTRI/2024/07/069920 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of contacts between teeth after proximal stripping during fixed orthodontic treatment. |
|
Scientific Title of Study
|
Assessment of interdental contacts after proximal stripping during fixed orthodontic treatment - An in-vivo study |
| 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. Deepika Singh |
| Designation |
Postgraduate student |
| Affiliation |
ITS Dental College, Hospital And Research centre, Greater Noida |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
ITS Dental College, Hospital and Research Centre,
47, Knowledge Park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9817280290 |
| Fax |
|
| Email |
deepika2022@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anshul Singla |
| Designation |
Professor and Head of Department |
| Affiliation |
ITS Dental College, Hospital And Research centre, Greater Noida |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
ITS Dental College, Hospital and Research Centre,
47, Knowledge Park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9817280290 |
| Fax |
|
| Email |
anshulsingla@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika SIngh |
| Designation |
Postgraduate student |
| Affiliation |
ITS Dental College, Hospital And Research centre, Greater Noida |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
ITS Dental College, Hospital and Research Centre,
47, Knowledge Park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9817280290 |
| Fax |
|
| Email |
deepika2022@its.edu.in |
|
|
Source of Monetary or Material Support
|
| ITS Dental College, Hospital and Research Centra,
47, Knowledge Park III, Greater Noida,
Uttar Pradesh - 201308
India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
ITS Dental College, Hospital and Research Centre,
47, Knowledge Park III, Greater Noida |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepika Singh |
ITS Dental College, Hospital and Research Centre, Greater Noida |
Department of Orthodontics and Dentofacial Orthopaedics
ITS Dental College, Hospital and Research Centre,
47, Knowledge Park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9817280290
deepika2022@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental College, Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interproximal Reduction |
Interproximal reduction by 4 different methods and follow up will be done at intervals of 3 months, 6months and 9 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mild to moderate crowding undergoing Fixed orthodontic treatment.
Patients of age group 15-35 years.
Patients with premolars of adequate mesio-distal width present bilaterally.
Patients with good oral hygiene compliance.
Patient with no evident attrition-related enamel loss on the proximal surfaces of the teeth.
Patients with no deformed teeth or enamel cracks on the proximal surfaces.
Patients with no evident demineralization (white or brown spots).
Patients with no restorations on proximal surfaces of premolars.
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic disease affecting the oral health of the patient.
Patients with presence of restorations or fillings in premolar region.
Patients with periodontitis.
Pregnant patient or lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the changes in interdental papilla and tightness of proximal tooth contact.
|
At baseline, 3months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maintainence of oral hygiene & interdental spaces |
At baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
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
|
|
Brief Summary
|
total 40 number of patients with mild to moderate crowding requiring interproximal stripping are randomly divided into 4 groups of 10 patients each. the tooth size- arch length discrepancy is determined and the amount of enamel to be reduced from each side is determined. interedenal spaces will be measured using mechanical thickness gauge. the gauge must be inserted into the interdental space without resistance and without displacing the tooth. before stripping, a wedge will be put interdentally to protect the interdental papilla and stripping will be performed. the interdental space will be re-measured to determine the amount of space gained. the teeth will be polished with a fine polyester manual strip to prevent plaque accumulation and topical fluoride will be applied. using a sealant will help produce a proximal surface as smooth as possible. papillary recession height and interproximal width will be measured. |