| CTRI Number |
CTRI/2025/03/083714 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessment and comparison of the clinical bracket failure rate of a novel orthodontic adhesive enhanced with silver nanoparticles versus a conventional orthodontic adhesive– An In vivo study
|
|
Scientific Title of Study
|
Evaluation and Comparison of clinical bracket failure rate of a new orthodontic adhesive modified with silver nanoparticles with conventional orthodontic adhesive : 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 |
Urja tushar Modi |
| Designation |
PG student |
| Affiliation |
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat |
| Address |
Vishwajyoti ashram , near vidyakunj school, muj mahuda
Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near Vidyakunj School , Mujmahuda
Vadodara
GUJARAT
390011
India |
| Phone |
9909269289 |
| Fax |
|
| Email |
urja.modii@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udita Thakkar |
| Designation |
Reader |
| Affiliation |
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat |
| Address |
Vishwajyoti ashram,near vidyakunj school,muj mahuda
Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near Vidyakunj School , Mujmahuda
Vadodara
GUJARAT
390011
India |
| Phone |
09930368534 |
| Fax |
|
| Email |
druditamehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Urja tushar Modi |
| Designation |
PG student |
| Affiliation |
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat |
| Address |
Vishwajyoti ashram, near vidyakunj school,muj mahuda
Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near Vidyakunj School , Mujmahuda
Vadodara
GUJARAT
390011
India |
| Phone |
9909269289 |
| Fax |
|
| Email |
urja.modii@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Manubhai Patel Dental college and Hospital, Vadodara
Vishwajyoti ashram, near vidyakunj school, muj mahuda, vadodara, Gujarat, India , 390011 |
|
|
Primary Sponsor
|
| Name |
Urja tushar Modi |
| Address |
1,Ajit society, baghikhana road,navapura
Opposite polo ground, Vadodara, gujarat,India, 390001 |
| 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 |
| Dr Urja tushar Modi |
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat |
Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near Vidyakunj School , Mujmahuda, 390011
Vadodara
GUJARAT |
9909269289
urja.modii@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) FOR RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional orthodontic adhesive |
orthodontic adhesive without silver nanoparticles and check bracket failure during 4 months of treatment |
| Intervention |
Orthodontic adhesive with silver nanoparticles |
Silver nanoparticlesd added to orthodontic adhesive and checked for bracket failure during 4 months of treatment |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients ranging from 15-35 years, who are undergoing fixed orthodontic treatment with 0.022 x 0.028 slot metal bracket.
2. Patients with mild to moderate crowding requiring fixed orthodontic treatment.
3. Patients having healthy periodontium.
|
|
| ExclusionCriteria |
| Details |
1. Periodontally compromised patients.
2. Patients with clefts, syndromes or brackets debonded by the clinician, brackets bonded by a different adhesive or protocol, and brackets from a different company.
3. Patients who are allergic to Silver. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical bracket failure rate of a new adhesive containing silver nanoparticles |
During 4 months of initial treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the bracket failure rate with conventional orthodontic adhesive |
during 4 months of initial treatment |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
| STUDY DESIGN
This study will include 192 teeth (96 each group) of patients who are undergoing fixed orthodontic treatment in the Department of Orthodontics and Dentofacial Orthopedics, Manubhai Patel Dental College, Hospital & O.R.I., Vadodara will be considered for this study.
Materials: a. Materials on which the experiment will be conducted : 1. Orthodontic adhesive (3M Unitek Transbond XT) modified with silver nanoparticles 2. Orthodontic adhesive (3M Unitek Transbond XT) b. Materials used to carry the experiment : 1. 192 Mclaughin Bennett Trevisi (MBT) prescription brackets (American Orthodontics, St. Paul,USA) of 0.022 x 0.028” slot 2. Etchant (3M Unitek Etching gel) 3. Dentine bonding agent 4. LED curing light (woodpecker)
METHODOLOGY: In this in-vivo study, 192 teeth (96 each group) of patients who are undergoing orthodontic treatment with a 0.022 x 0.028” slot MBT bracket system, and who fulfill all inclusion criteria will be selected for the study. All the teeth present in maxillary arch from 15 to 25 will be cleaned and etched with 37% Phosphoric acid then bonding agent will be applied and cured for 15 seconds. Further the brackets will be bonded with modified adhesive containing silver nanoparticles in experimental group whereas brackets will be bonded with conventional adhesive without silver nanoparticles in control group. Patient will be called when the bracket is debonded within the span of 4 months and number of bracket failure rate will be recorded.(T1) The following details will be recorded for each patient : (1) Biographical details (name, age, and gender) (2) Skeletal Pattern (Class I and II) (3) Time of bracket failure (4) Tooth number (5) Type of wire Once the bracket has been debonded, no further assessment will be done for that particular bracket. Both the failure rates will be compared. |
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