Effect of Primer Application on the Lingual Retainer

Dental Bonding Clinical Trial

Official title:

Effect of Self-Etch Primer Application on the Bond Failure Rate of a Mandibular Bonded Lingual Retainer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340595
• Other study ID #: 2013/17
• Status: Completed
• Phase: N/A
• Start date: March 2, 2014
• Est. completion date: July 23, 2016

Study information

• Verified date: April 2022
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 23, 2016
• Est. primary completion date: November 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 34 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Dental Bonding
• Orthodontic Retainers

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ondokuz Mayis University	Sabahat Yazicioglu

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bond Failure Rate of a Mandibular Bonded Lingual Retainer	Bond Failure Rate of a Mandibular Bonded Lingual Retainer	24 months