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

Orthodontic Appliance Complication Clinical Trial

— failurerate  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05766033
• Other study ID #: Bracket failure rate
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: March 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria.

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

Intervention

Other:
• Enamel 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).

Locations

Country	Name	City	State
Iraq	Hussain Qays Aswad	Baghdad	Alrusafaa

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	6 months
Secondary	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.	6 months