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

Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin: A Split-Mouth Randomized Controlled Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Bracket Bonding; Bracket Failure; RMGIC; Conventional Bracket Bonding
• Intervention / Treatment: Other: V-Prep and Resin-Modified Glass Ionomer Cement; Other: Conventional Acid-Etch Composite Resin

Detailed Description

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. To minimize inter-operator variability for any of the procedures listed above, all bonding will be completed by a single operator (principal investigator) that has been trained on the trial.

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 44000
      • Foundation University College of Dentistry and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V-Prep and Resin-Modified Glass Ionomer Cement; V prep with sodium hypochlorite and bonding with RMGIC	Other: V-Prep and Resin-Modified Glass Ionomer Cement; V-Prep with sodium hypochlorite and bonding with Resin-Modified Glass Ionomer Cement
Active Comparator: Conventional Acid-Etch Composite Resin; Conventional Composite Resin Bonding	Other: Conventional Acid-Etch Composite Resin; Conventional Composite Resin bonding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 9, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Bracket failure; Conventional Bonding; V-prep and RMGIC
• Other Study ID Numbers: FUCD-Ortho- 26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: University policy to maintain patients confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No