Effect of Primer Application on the Lingual Retainer

NCT05340595 | Completed

• 1 other identifier: 2013/17
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months. Materials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores. The chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P \< 0.05.

Conditions

Dental Bonding; Orthodontic Retainers

Outcome Measures

Primary Outcomes (1)

• Bond Failure Rate of a Mandibular Bonded Lingual Retainer

  Bond Failure Rate of a Mandibular Bonded Lingual Retainer

  24 months

Study Arms (2)

Control group

OTHER

The primer (Transbond XT Primer; 3M Unitek, California) was applied in a thin and uniform coat. Then the adhesive resin (Transbond LR Light Cure Adhesive Paste; 3M Unitek, California) was administered to the lingual surface of the anterior teeth and the lingual retainer was placed in position. The adhesive resin was polymerized from two directions for a total of 20 s using a visible-light curing unit (Hilux 200, Benlioglu Dental Inc., Ankara, Turkey) with an output power of 600 mW/cm2.

Other: Orthodontic retainer bonding

Study group

ACTIVE COMPARATOR

In the study group, the SEP (3M Unitek, Monrovia, California) was used according to the manufacturer's instructions, namely it was administered to the lingual surfaces of the teeth and rubbed for 3 s. Then a gentle burst of dry air was delivered to thin the primer. In the control group, the lingual surfaces of the teeth were etched using 37% phosphoric etchant liquid gel (3M Espe, St Paul, Minnesota, USA) for 30 s, followed by rinsing and drying.

Other: Orthodontic retainer bonding

Interventions

Orthodontic retainer bonding OTHER

Self-etch primer (Transbond XT Primer; 3M Unitek, California) was administered to the teeth's lingual surfaces.

Control group; Study group

Eligibility Criteria

• Age: 11 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals who will continue to the retention phase after fixed orthodontic treatment,
• Presence of all mandibular incisor and canine teeth,
• Good oral hygiene,
• No caries,
• No fractures,
• Healthy periodontal condition,
• No restorations,
• No previous bonded retainer,
• No traumatic parafunctional habits such as bruxism.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead
• Sabahat Yazıcıoğlu: collaborator

Related Publications (2)

• Elekdag-Turk S, Isci D, Turk T, Cakmak F. Six-month bracket failure rate evaluation of a self-etching primer. Eur J Orthod. 2008 Apr;30(2):211-6. doi: 10.1093/ejo/cjm119. Epub 2008 Jan 23.

  PMID: 18216373 BACKGROUND

• Sfondrini MF, Cacciafesta V, Scribante A, De Angelis M, Klersy C. Effect of blood contamination on shear bond strength of brackets bonded with conventional and self-etching primers. Am J Orthod Dentofacial Orthop. 2004 Mar;125(3):357-60. doi: 10.1016/j.ajodo.2003.09.022.

  PMID: 15014415 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 22, 2022
• Study Start: March 2, 2014
• Primary Completion: November 2, 2015
• Study Completion: July 23, 2016
• Last Updated: April 28, 2022

Record last verified: 2022-04