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

NCT05766033 | Unknown DMC

• 1 other identifier: Bracket failure rate
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Appliance Complication

Outcome Measures

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 .

  6 months

Secondary Outcomes (1)

• Adhesive remenant index

  6 months

Study Arms (2)

Novel etchent paste

EXPERIMENTAL

Other: Enamel conditioning with a novel etchant paste

Phosphoric acid 37%

ACTIVE COMPARATOR

Other: Enamel conditioning with a novel etchant paste

Interventions

Enamel conditioning with a novel etchant paste OTHER

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

Novel etchent paste; Phosphoric acid 37%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Hussain Qays Aswad

Baghdad, Alrusafaa, Iraq

Location

Related 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.

  PMID: 32382380 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Allocation concealment is achieved with sequentially numbered, opaque sealed envelopes containing the side allocation of the etchant, prepared before the trial. An independent person is responsible for opening the next envelope in sequence and implementing the randomization process. Blinding of the operator at bracket bonding is not possible because of the nature of the intervention. Blinding of the patient is not considered relevant.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: hqaswad

Model Details: This is a multi-center, single-operator, split-mouth randomized controlled trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: June 2, 2022
• Primary Completion: February 28, 2023
• Study Completion: October 30, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

IR (1)