Effect of Primer Application on the Lingual Retainer

NCT ID: NCT05340595

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-02

Study Completion Date

2016-07-23

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Bonding Orthodontic Retainers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

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.

Group Type OTHER

Orthodontic retainer bonding

Intervention Type OTHER

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

Study group

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.

Group Type ACTIVE_COMPARATOR

Orthodontic retainer bonding

Intervention Type OTHER

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

Interventions

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Orthodontic retainer bonding

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

11 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sabahat Yazıcıoğlu

UNKNOWN

Sponsor Role collaborator

Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fethiye ÇAKMAK ÖZLÜ

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 18216373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15014415 (View on PubMed)

Other Identifiers

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2013/17

Identifier Type: -

Identifier Source: org_study_id

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