Prosthesis UserNCT06447389
"Clinical Evaluation of Retraction Cord Effectiveness Using Intraoral Scanner
A study testing retraction cordu (SURE-CORD®PLUS) in people with Prosthesis User and Digitalism, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User, Digitalism
- What is being tested?
- retraction cordu (SURE-CORD®PLUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Failure to accept voluntary participation in the study after reading the informed consent form.
- General health condition being unsuitable for prosthetic treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry Department of Prosthodontics
Ankara, Altındağ, 06230
About this study
Official title: "Clinical Evaluation of Retraction Cord Effectiveness Using Direct Digitalization Method in Determining the Preparation Margin Line"
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.
Read the detailed description
This study is designed to produce temporary bridges based on two supporting teeth, fabricated using an intraoral scanner, and to evaluate the marginal fit of these bridges based on two different digital measurements obtained with and without the use of retraction cord on the patient.
The study will encompass patients with a single missing tooth in the posterior region of the lower or upper jaw, specifically involving the second premolar or first molar, planned for a three-unit tooth-supported fixed partial denture (SPP). Prior to preparation, patients will be examined for the assessment of the soft tissue around the teeth, and data collection will be conducted in accordance with the criteria outlined in Table-1, following the guidelines of the 2017 Consensus Report on the Classification of Periodontal and Peri-implant Diseases and Conditions regarding periodontal health and gingival diseases in healthy and reduced periodontium.
Subsequently, the abutment teeth will be prepared stepwise using high-speed rotary instruments and diamond preparation burs to accommodate fixed restorations.
The study groups will be formed considering the presence or absence of retraction application. The groups will be defined as Group I (No retraction cord) and Group II (Retraction cord present).
In Group I, digital impressions will be taken directly in all patients without placing a retraction cord.
In Group II, digital impressions will be taken in the same patients using a "000" knitted retraction cord and a single retraction cord technique.
As part of this plan, digital impressions of the abutment teeth for the temporary bridge will be taken both before and after the application of the retraction cord. The temporary bridges fabricated from these impressions will then be evaluated intraorally.
For each case included in the study, the .stl files from the initial impression for the restoration, the post-production impression, and the restoration itself will be superimposed and digitally analyzed using reverse engineering software.
The depths of the preparation finish lines will be recorded using a probe. The recorded depths of the preparation finish lines and the amounts of marginal discrepancy of the restorations will be examined together. Based on the obtained data, the effect of the preparation finish line depth on the marginal fit of the restorations will be evaluated.
- Conditions
- Prosthesis User, Digitalism
- Being tested
- retraction cordu (SURE-CORD®PLUS)
- Keywords
- digital dentistry, effectiveness, retraction cord
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: retraction cordu (SURE-CORD®PLUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 year
Secondary outcomes (1)
Probing dept
Secondary data will be collected by measuring the step depths on the abutment teeth after preparation. These measurement points will be compared with the marginal fit of the temporary bridges at the same points, and the effect of step depth on marginal fit will be evaluated.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start15 Dec 2022
- Primary completion15 Aug 2023
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kıvanç Akça, Hacettepe University
- Investigators
- Kıvanç Akça, DDS,PhD, Principal investigator, Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447389
- Sponsor's protocol ID
- KA-22056
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24360008Martins 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.
PubMed 32008797Mangano 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.
PubMed 31936096Huang 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.
PubMed 26378615
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Clinical Evaluation of Retraction Cord Effectiveness Using Direct Digitalization Method in Determining the Preparation Margin Line"
- ClinicalTrials.gov ID
- NCT06447389
- Acronym / sponsor ID
- KA-22056
- Conditions
- Prosthesis User, Digitalism
- Keywords
- digital dentistry, effectiveness, retraction cord
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to produce temporary bridges based on two supporting teeth, fabricated using an intraoral scanner, and to evaluate the marginal fit of these bridges based on two different digital measurements obtained with and without the use of retraction cord on the patient.
The study will encompass patients with a single missing tooth in the posterior region of the lower or upper jaw, specifically involving the second premolar or first molar, planned for a three-unit tooth-supported fixed partial denture (SPP). Prior to preparation, patients will be examined for the assessment of the soft tissue around the teeth, and data collection will be conducted in accordance with the criteria outlined in Table-1, following the guidelines of the 2017 Consensus Report on the Classification of Periodontal and Peri-implant Diseases and Conditions regarding periodontal health and gingival diseases in healthy and reduced periodontium.
Subsequently, the abutment teeth will be prepared stepwise using high-speed rotary instruments and diamond preparation burs to accommodate fixed restorations.
The study groups will be formed considering the presence or absence of retraction application. The groups will be defined as Group I (No retraction cord) and Group II (Retraction cord present).
In Group I, digital impressions will be taken directly in all patients without placing a retraction cord.
In Group II, digital impressions will be taken in the same patients using a "000" knitted retraction cord and a single retraction cord technique.
As part of this plan, digital impressions of the abutment teeth for the temporary bridge will be taken both before and after the application of the retraction cord. The temporary bridges fabricated from these impressions will then be evaluated intraorally.
For each case included in the study, the .stl files from the initial impression for the restoration, the post-production impression, and the restoration itself will be superimposed and digitally analyzed using reverse engineering software.
The depths of the preparation finish lines will be recorded using a probe. The recorded depths of the preparation finish lines and the amounts of marginal discrepancy of the restorations will be examined together. Based on the obtained data, the effect of the preparation finish line depth on the marginal fit of the restorations will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the Effectiveness of Retraction Cord | Other | Other: retraction cordu (SURE-CORD®PLUS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to accept voluntary participation in the study after reading the informed consent form.
- General health condition being unsuitable for prosthetic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retraction cordu (SURE-CORD®PLUS)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. | Other | Evaluation of the Effectiveness of Retraction Cord |
Primary outcome
Digital analysis
Time frame: 1.5 year
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 secondary outcome
Probing dept
Time frame: 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Results publication: PubMed 24360008Acar 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.
- Results publication: PubMed 32008797Martins 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.
- Results publication: PubMed 31936096Mangano 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.
- Results publication: PubMed 26378615Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kıvanç Akça, DDS,PhD principal investigator
Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retraction cordu (SURE-CORD®PLUS) in people with Prosthesis User and Digitalism, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital analysis (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06447389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.