Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin

NCT07828431 | Active Not Recruiting

• 1 other identifier: FUCD-Ortho- 26
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Ethical approval will be obtained by the FUSH and informed consent will be obtained from individual patients/guardians in writing. Inclusion and exclusion criteria will be used to obtain random patient samples within the Orthodontic Department of FUCD\&H and Baseline parameters like age, gender, O'Leary Plaque Score, malocclusion classification type and degree of overbite will be recorded. Patients will be screened one at a time if they are eligible. For this purpose, sequentially numbered, opaque sealed envelopes will be opened just before the bonding assignment for allocation concealment. Both orally and in writing to all patients. Tooth surfaces will be pumiced and standardized. While, the Primer light-cured for 10-sec each item, the Control group (enamel) etched for 30-sec, washed for 15-sec and air dried to a frosty white. The tough brackets will be attached, with a baseline underneath, with a thin layer of composite resin pressed down on optimum. Light cured for 10 seconds on mesial and distal surfaces to remove excess adhesive (STEP 7). Group II (V-Prep): Enamel surface was were in contact with 0%-1.5% diluted Sodium Hypochlorite during 60 seconds, rinsed and thoroughly dried; then the V-Prep was applied. 37% phosphoric acid gel for 30 Sec, rinsed for 15 Sec and dried until a frost white appearance on the etched enamel area. The first is called Primer and will be light cured for 10 seconds. A template will then be provisionally fixed to secure the bottom of the bracket in place with Resin-Modified Glass Ionomer Cement. Clean of excess adhesive, and cure for 10 seconds mesial and distal. Then instead of going to bonding, this will be taken out and ligated to a 0.012-in Ni-Ti archwire. Will follow a 30 days interval series of 6 follow-up visits, monthly visits throughout 6 months

Conditions

Bracket Bonding; RMGIC; Conventional Bracket Bonding; Bracket Failure

Keywords

Bracket failure; Conventional Bonding; V-prep and RMGIC

Outcome Measures

Primary Outcomes (1)

• Bond Failure Rate of Orthodontic Brackets

  Time-to-failure of orthodontic brackets between the V-Prep and Resin-Modified Glass Ionomer Cement \[RMGIC\] and conventional 37% phosphoric acid-etch composite resin technique.

  6 months

Study Arms (2)

V-Prep and Resin-Modified Glass Ionomer Cement

EXPERIMENTAL

V prep with sodium hypochlorite and bonding with RMGIC

Other: V-Prep and Resin-Modified Glass Ionomer Cement

Conventional Acid-Etch Composite Resin

ACTIVE COMPARATOR

Conventional Composite Resin Bonding

Other: Conventional Acid-Etch Composite Resin

Interventions

V-Prep and Resin-Modified Glass Ionomer Cement OTHER

V-Prep with sodium hypochlorite and bonding with Resin-Modified Glass Ionomer Cement

V-Prep and Resin-Modified Glass Ionomer Cement

Conventional Acid-Etch Composite Resin OTHER

Conventional Composite Resin bonding

Conventional Acid-Etch Composite Resin

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 12-18 years
• The extraction was limited to Two arches.
• Functional Overbite/Underbite ( \< 50% or 1, 2-3 mm?)
• Malocclusions Class I or II

You may not qualify if:

• Class III malocclusion
• Type 2: Facial Osteopathy (Cleft lip or palate)
• The history of allergic reactions to dental materials goes back to 1903.Allergic reactions to dental materials date back to 1903.
• Developmental enamel defects (fluorosis, hypoplasia)

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Dentistry and Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)