"Clinical Evaluation of Retraction Cord Effectiveness Using Intraoral Scanner

NCT06447389 | Active Not Recruiting

• 1 other identifier: KA-22056
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Dental-supported fixed partial dentures (FPDs) have long been a commonly preferred treatment method for the rehabilitation of teeth with excessive substance loss and for addressing existing tooth deficiencies. Crucial factor affecting the success and quality of FPDs is the marginal fit of the restoration. Marginal discrepancy refers to the vertical or horizontal gap between the restoration finish line and the preparation finish line. To achieve high marginal fit restorations, gingival retraction techniques are used with the aim of removing the marginal gingiva away from the finish line. Retraction cords are commonly used for this purpose nowadays. The aim of the study is to evaluate the effect of retraction cords on the preparation finish line and the marginal fit of produced restorations using direct digital measurement methods.

Conditions

Prosthesis User; Digitalism

Keywords

digital dentistry; effectiveness; retraction cord

Outcome Measures

Primary Outcomes (1)

• Digital analysis

  The comparison of the marginal fit of restorations fabricated from digital data with and without the use of a retraction cord was performed using reverse engineering software. The digital scans taken after preparation, the digital scans taken after restoration delivery, and the .stl files of the restorations were superimposed within the software and analyzed for marginal fit.

  1.5 year

Secondary Outcomes (1)

• Probing dept

  1.5 year

Study Arms (1)

Evaluation of the Effectiveness of Retraction Cord

OTHER

For each case, two tooth-supported restorations will be produced: one with and one without the application of a retraction cord. The accuracy of the marginal fit of the produced restorations will be determined through digital analysis of the data.

Other: retraction cordu (SURE-CORD®PLUS)

Interventions

retraction cordu (SURE-CORD®PLUS) OTHER

The evaluation of the effectiveness of retraction cords in determining the restoration margin in the fabrication of short fixed partial dentures for patients with missing teeth.

Evaluation of the Effectiveness of Retraction Cord

Eligibility Criteria

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

You may qualify if:

• Voluntary participation after reading and understanding the informed consent form.
• Over 18 years of age with no general health issues.
• Presence of a single missing posterior tooth in the upper or lower jaw.
• Possession of "clinical gingival health" in terms of periodontal condition ("Clinical gingival health of a healthy periodontium is defined as the absence of bleeding on probing, erythema, edema, symptoms, and no loss of bone or attachment.(17))
• Teeth with less than half of the tooth structure lost that do not require post-core treatment.

You may not qualify if:

• Failure to accept voluntary participation in the study after reading the informed consent form.
• General health condition being unsuitable for prosthetic treatment.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry Department of Prosthodontics

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Related Publications (4)

• Acar O, Erkut S, Ozcelik TB, Ozdemir E, Akcil M. A clinical comparison of cordless and conventional displacement systems regarding clinical performance and impression quality. J Prosthet Dent. 2014 May;111(5):388-94. doi: 10.1016/j.prosdent.2013.08.009. Epub 2013 Dec 18.

  PMID: 24360008 RESULT

• Martins FV, Santana RB, Fonseca EM. Efficacy of conventional cord versus cordless techniques for gingival displacement: A systematic review and meta-analysis. J Prosthet Dent. 2021 Jan;125(1):46-55. doi: 10.1016/j.prosdent.2019.09.009. Epub 2020 Jan 31.

  PMID: 32008797 RESULT

• Mangano FG, Margiani B, Solop I, Latuta N, Admakin O. An Experimental Strategy for Capturing the Margins of Prepared Single Teeth with an Intraoral Scanner: A Prospective Clinical Study on 30 Patients. Int J Environ Res Public Health. 2020 Jan 7;17(2):392. doi: 10.3390/ijerph17020392.

  PMID: 31936096 RESULT

• Huang C, Somar M, Li K, Mohadeb JVN. Efficiency of Cordless Versus Cord Techniques of Gingival Retraction: A Systematic Review. J Prosthodont. 2017 Apr;26(3):177-185. doi: 10.1111/jopr.12352. Epub 2015 Sep 17.

  PMID: 26378615 RESULT

Study Officials

• Kıvanç Akça, DDS,PhD

  Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The investigator, who performed the statistical analysis, will not know which group the obtained primary and secondary data belong to until all evaluations are completed.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 7, 2024
• Study Start: December 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: June 15, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)