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

Phase 3

Recruiting

Conditions: Other disorders of teeth and supporting structures,

Registration Number: CTRI/2025/03/083714

Lead Sponsor: Urja tushar Modi

Brief Summary: | |

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|**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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 96

Inclusion Criteria

Patients ranging from 15-35 years, who are undergoing fixed orthodontic treatment with 0.022 x 0.028 slot metal bracket.
Patients with mild to moderate crowding requiring fixed orthodontic treatment.
Patients having healthy periodontium.

Exclusion Criteria

Periodontally compromised patients.
Patients with clefts, syndromes or brackets debonded by the clinician, brackets bonded by a different adhesive or protocol, and brackets from a different company.
Patients who are allergic to Silver.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical bracket failure rate of a new adhesive containing silver nanoparticles	During 4 months of initial treatment

Secondary Outcome Measures

Name	Time	Method
Compare the bracket failure rate with conventional orthodontic adhesive	during 4 months of initial treatment

Trial Locations

Locations (1): Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat
🇮🇳
Vadodara, GUJARAT, India
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat
🇮🇳Vadodara, GUJARAT, India
Dr Urja tushar Modi
Principal investigator
9909269289
urja.modii@gmail.com