ClinicalTrials.gg
Status unknownNCT05766033failurerateUpdated Mar 21, 2023

Bracket Failure With a Novel Etchant Paste. A Randomized Clinical Trial

An interventional study of Enamel conditioning with a novel etchant paste in Orthodontic Appliance Complication, sponsored by University of Baghdad. Status unknown at 1 site in Iraq. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by University of Baghdad · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

To investigate metallic brackets failure rate bonded post enamel conditioning with a novel CaP etchant paste in comparison with those bonded following conventional enamel etching with PA gel over a period of 6 months.

Read the detailed description

Acid etching of tooth surfaces to promote the bonding of orthodontic attachments to the enamel has been a routine procedure in orthodontic treatment since the 1960s. Various types of orthodontic etchants and etching techniques have been introduced in the past five decades. Michael G Buonocore in revolutionized dentistry with his historical paper: "A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces" depicting the advantage of etching and bonding of acrylic to enamel. It forever changed the practice of dentistry. Buonocore and Silverstone led the profession in acid etching and bonding of resin to etched enamel surfaces. These developments allowed orthodontists to bond brackets reliably and apply forces to move teeth without banding every tooth or having brackets deboned. Buonocore reported that 85% phosphoric acid etchant significantly increased the adhesion of acrylic resin to enamel. Since then, a variety of etchants have been used with different concentrations and etching times. These include hydrofluoric acid, citric acid, hydrochloric acid, maleic acid, nitric acid, and phosphoric acid in a variety of concentrations. Suggested etching times can vary from 15 to 60 seconds. The tooth enamel surface is known for its low-energy and hydrophobic properties, with its outermost layer being rich in fluoride. Enamel etching with phosphoric acid (PA) removes the fluoride-rich layer, dissolves enamel mineral, creates micro- pores, and renders a high-energy and hydrophilic enamel surface to permit wetting by an adhesive; yet at the expense of increased surface porosity, susceptibility to staining, caries, more remnant adhesive and enamel loss. Fixation of brackets to teeth involves joining of two different solid substrates or adherents through an intervening adhesive layer. Bracket bases are currently provided with mesh designs that ensure robust mechanical interlocking between the bracket and adhesive, whilst research is ongoing to improve enamel conditioning strategies that can attain clinically successful bond strengths yet maintain an unblemished enamel surface. Alternative methods to conventional enamel etching with phosphoric acid have been sought aiming at decreasing the bond strength to reduce the incidence of enamel damage. The use of glass ionomer cements for orthodontic bonding decreased the occurrence of enamel damage, yet at the expense of clinically unacceptable bond strengths. On the other hand, the use of laser etching and self- etch primers resulted in bracket shear bond strengths comparable to the conventional etch-and-rinse approach, but could not eliminate enamel damage. In 2019, Ibrahim et al developed a new bioactive orthodontic etchant paste made of calcium-phosphate (CaP), which could alleviate subsurface enamel demineralization in comparison with the traditional phosphoric acid etchant and the pre-clinical viability assessment using in vitro studies showed exemplary advantages. The new low-pH CaP paste etchant application is a clinically viable bracket bonding method with steps similar to PA application that yielded adequate bond strength with the advantages of minimal adhesive remnants and no enamel chipping or cracking on deboning of the bracket.

02

Conditions studied

  • Orthodontic Appliance Complication
03

In context

Lead sponsor

University of Baghdad is the lead sponsor of 166 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Full permanent dentition including incisors, canines, premolars, and first molars.
  • Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide.
  • No previous orthodontic treatment with fixed appliances.

Exclusion criteria

Exclusion Criteria:

  • Were unable to give informed consent) Had craniofacial anomalies.
  • Required orthognathic surgery as part of their treatment.
  • Had congenital enamel defects
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Novel etchent paste

    Other: Enamel conditioning with a novel etchant paste

  • Active comparator
    Phosphoric acid 37%

    Other: Enamel conditioning with a novel etchant paste

Interventions

  • OtherEnamel conditioning with a novel etchant paste

    The maxillary and mandibular incisors, canines, and premolars for each patient will be conditioned using the Novel etchent paste on one side (experimental), while the other side (control) conditioned with a phosphoric acid gel 37% . Both systems use identical brackets and adhesive system (differ only with regard to the etching system).

    Also known as: Etching for enamel for bracket bonding

06

What researchers measure

Primary outcomes

  1. Bracket failure rate

    Patients with repeated bond failures caused by habits or trauma would be excluded from further analysis.only counting the number of brackets that broken .

    Time frame: 6 months

Secondary outcomes

  1. Adhesive remenant index

    Assessment of the amount of remnant adhesive left post bracket failure (for both methods).This index system was developed on the basis of a pilot study of 20 extracted teeth and the criteria were as follows: score 0 = no adhesive left on the tooth; score 1 = less than half of the adhesive left on the tooth; score 2 = more than half of the adhesive left on the tooth; and score 3 = all adhesive left on the tooth with a distinct impression of the bracket mesh.

    Time frame: 6 months

07

Study locations

1 site
  • Hussain Qays Aswad
    Baghdad, Alrusafaa, Iraq
08

References and documents

Publications

  • Ibrahim AI, Al-Hasani NR, Thompson VP, Deb S. Resistance of bonded premolars to four artificial ageing models post enamel conditioning with a novel calcium-phosphate paste. J Clin Exp Dent. 2020 Apr 1;12(4):e317-e326. doi: 10.4317/jced.56764. eCollection 2020 Apr. PubMed 32382380 ↗

Individual participant data

Plan to share: Undecided — till now there is no plan to share it when i found it i will updated it.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2022 to primary completion in Feb 2023, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2023
First posted
Mar 13, 2023
StartActual
Jun 2, 2022
Primary completionActual
Feb 28, 2023
CompletionEst.
Oct 30, 2023
Last update
Mar 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05766033
Responsible party
Hussein Qays Aswad (hqaswad, University of Baghdad) — Principal investigator
First posted
Mar 13, 2023
Start date
Jun 2, 2022
Primary completion
Feb 28, 2023
Completion
Oct 30, 2023 (estimated)
Last update
Mar 21, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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