Tooth AbrasionNCT07734935
The Effect of Retraction Cord on the Surrounding Periodontal Tissues in Restorative Treatment
A study testing Gingival Retraction Cord, Composite Resin Restorative and Universal Adhesive - G-Premio Bond in people with Tooth Abrasion and Gingival Recessions, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether a retraction cord affects gum health when used during tooth restoration procedures. A retraction cord is a thin thread that dentists sometimes place between the tooth and the gum surrounding it, to gently push the gum aside so the restoration can be performed in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Abrasion, Gingival Recessions, Non-Carious Cervical Lesions (NCCLs)
- What is being tested?
- Gingival Retraction Cord, Composite Resin Restorative and Universal Adhesive - G-Premio Bond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2025to 23 Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Systemically healthy
- Non-smoker
- Periodontally healthy (whole-mouth bleeding on probing <10%, mean probing pocket depth ≤3 mm, mean Plaque Index and Gingival Index ≤1.1)
- At least 20 teeth in occlusion (full/near-full dentition)
- At least 4 non-carious cervical lesions, each ≥1 mm in depth, involving both enamel and dentin, with vital pulp status
Who cannot join
- Presence of systemic disease
- Use of medication known to affect inflammatory response during the study period
- Inability or unwillingness to comply with follow-up visits
- Pregnancy or lactation
- Current smoking
- Presence of periodontal disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul, 34116
About this study
Official title: Evaluation of the Effects of Retraction Cord Placed in the Gingival Sulcus on Periodontal Tissues in Restorative Treatment
The goal of this clinical trial is to learn whether a retraction cord affects gum health when used during tooth restoration procedures. A retraction cord is a thin thread that dentists sometimes place between the tooth and the gum surrounding it, to gently push the gum aside so the restoration can be performed in a clean surface isolated from saliva.
The study includes adult teeth with tooth damage near the gumline that has not been caused by decay, yet needs a restoration. The main research question is: Does using a retraction cord make a difference for gum health as opposed to not using one? Participants will be assigned into four separate groups. Two groups will receive a restoration with one type of bonding material, either with or without a retraction cord. The other two groups will receive a restoration with a different kind of bonding material, either with or without a retraction cord.
Researchers will check gum health status before the restorations and again on days 1, 7, and 28. They will observe symptoms such as swelling in the gums, bleeding of the gums, and gum margin positions. A fluid sample from the area between the gum and tooth will be collected to test for molecules of inflammation.
Read the detailed description
Study Rationale Retraction cord is commonly used during composite resin restoration of non-carious cervical lesions to control gingival crevicular fluid and improve visibility. Its effect on periodontal health in this specific application has not been well characterized. This study compares clinical periodontal parameters and gingival crevicular fluid (GCF) biomarker levels with and without cord placement.
Study Design This is a randomized, tooth-level (split-mouth), double-blind clinical trial following a 2×2 factorial design: adhesive system (G-Premio Bond vs. 3M Scotchbond Universal Plus) × retraction cord use (with vs. without). Eligible participants had multiple qualifying lesions, allowing individual teeth to be randomly allocated by coin-flip to different groups within the same participant. The participants and the examiner performing periodontal measurements were blinded to group allocation.
Procedures All restorations were placed by a single operator. In cord groups, an Ultrapak retraction cord was placed in the gingival sulcus before adhesive application and left in situ throughout the restorative procedure. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Keratinized Tissue Width, relative gingival margin position) and GCF samples were collected at baseline and on days 1, 7, and 28 after restoration. GCF biomarkers (TNF-α, IL-8, MMP-8, TIMP-1, PGE-2, LXA-4) were quantified using enzyme-linked immunosorbent assay (ELISA).
Enrollment Twelve participants (69 teeth) were initially enrolled; the study was completed with 10 participants (57 teeth) following two withdrawals.
- Conditions
- Tooth Abrasion, Gingival Recessions, Non-Carious Cervical Lesions (NCCLs), Periodontal Health, Gingival Crevicular Fluid, Gingival Inflammation
- Being tested
- Gingival Retraction Cord, Composite Resin Restorative, Universal Adhesive - G-Premio Bond, Universal Adhesive - Scotchbond Universal Plus
- Keywords
- Non-Carious Cervical Lesion, Retraction Cord, Gingival Crevicular Fluid, Composite Resin Restoration, Periodontal Health
- Medical subject headings
- Tooth Abrasion, Gingival Recession, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Retraction CordDevice
A knitted retraction cord placed in the gingival sulcus prior to composite restoration to displace gingival tissue and control gingival crevicular fluid during the bonding procedure.
Composite Resin RestorativeDevice
anofilled resin composite used for restoration of non-carious cervical lesions in all study groups.
Universal Adhesive - G-Premio BondDevice
Single-component universal adhesive system used for bonding the composite restoration to tooth structure.
Universal Adhesive - Scotchbond Universal PlusDevice
Universal adhesive system used for bonding the composite restoration to tooth structure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: G-Premio Bond, No Cord | Active comparator | Composite resin restoration of non-carious cervical lesions using 3M Filtek Easy Match Universal Restorative with G-Premio Bond adhesive, without retraction cord placement. Receives: Device: Composite Resin Restorative; Device: Universal Adhesive - G-Premio Bond |
| Group 2: G-Premio Bond + Retraction Cord | Experimental | Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement. Receives: Device: Gingival Retraction Cord; Device: Composite Resin Restorative; Device: Universal Adhesive - G-Premio Bond |
| Group 3: Scotchbond Universal Plus, No Cord | Active comparator | Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement. Receives: Device: Composite Resin Restorative; Device: Universal Adhesive - Scotchbond Universal Plus |
| Group 4: Scotchbond Universal Plus + Retraction Cord | Experimental | Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, with Ultrapak retraction cord placed in the gingival sulcus before restoration. Receives: Device: Gingival Retraction Cord; Device: Composite Resin Restorative; Device: Universal Adhesive - Scotchbond Universal Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Split-Mouth Gingival Index Difference (ΔGI) Over Time
Difference in Gingival Index (Löe \& Silness) between cord-treated and no-cord teeth within the same participant (split-mouth design), assessed at each time point. The Gingival Index (Löe \& Silness) ranges from 0 to 3, where 0 indicates healthy gingiva and 3 indicates severe inflammation; higher scores indicate a worse outcome.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Secondary outcomes (11)
Change in Plaque Index (PI)
Clinical assessment of dental plaque accumulation using the Silness \& Löe Plaque Index. The Plaque Index (Silness \& Löe) ranges from 0 to 3, where 0 indicates no plaque and 3 indicates abundant plaque; higher scores indicate a worse outcome.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Bleeding on Probing (BOP)
Percentage of probed sites showing bleeding on gentle periodontal probing.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Probing Pocket Depth (PPD)
Distance from the gingival margin to the base of the periodontal pocket, measured in millimeters with a periodontal probe.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Keratinized Tissue Width (KTW)
Width of keratinized gingiva, measured in millimeters from the gingival margin to the mucogingival junction.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Relative Gingival Margin Position
Position of the gingival margin relative to a fixed reference point, used to assess gingival recession or coronal displacement.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Tumor Necrosis Factor-alpha (TNF-α) Concentration
TNF-α concentration in gingival crevicular fluid (GCF) samples, quantified using enzyme-linked immunosorbent assay (ELISA), compared across treatment groups over time.
Measured: Baseline (before restoration), and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Interleukin-8 (IL-8) Concentration
IL-8 concentration in gingival crevicular fluid, quantified using ELISA.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Concentration
MMP-8 concentration in gingival crevicular fluid, quantified using ELISA.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Concentration
TIMP-1 concentration in gingival crevicular fluid, quantified using ELISA.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Prostaglandin E2 (PGE-2) Concentration
PGE-2 concentration in gingival crevicular fluid, quantified using ELISA.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Lipoxin A4 (LXA-4) Concentration
LXA-4 concentration in gingival crevicular fluid, quantified using ELISA.
Measured: Baseline, and Days 1, 7, and 28 after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start18 Feb 2025
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth AbrasionStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Çekici, Istanbul University
- Investigators
- Ali Cekici, DDS, PhD, Principal investigator, Istanbul UniversitySafa Tuncer, DDS, PhD, Study chair, Istanbul UniversityMehmet Cenkay Aydın, DDS, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734935
- Sponsor's protocol ID
- 2024/80
- Other IDs
- 2025-008
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to the absence of a formal data-sharing infrastructure. De-identified data may be made available from the corresponding author upon reasonable request for legitimate academic purposes.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Retraction Cord Placed in the Gingival Sulcus on Periodontal Tissues in Restorative Treatment
- ClinicalTrials.gov ID
- NCT07734935
- Acronym / sponsor ID
- 2024/80
- Conditions
- Tooth Abrasion, Gingival Recessions, Non-Carious Cervical Lesions (NCCLs), Periodontal Health, Gingival Crevicular Fluid, Gingival Inflammation
- Keywords
- Non-Carious Cervical Lesion, Retraction Cord, Gingival Crevicular Fluid, Composite Resin Restoration, Periodontal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 29 Jul 2026 (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.
The goal of this clinical trial is to learn whether a retraction cord affects gum health when used during tooth restoration procedures. A retraction cord is a thin thread that dentists sometimes place between the tooth and the gum surrounding it, to gently push the gum aside so the restoration can be performed in a clean surface isolated from saliva.
The study includes adult teeth with tooth damage near the gumline that has not been caused by decay, yet needs a restoration. The main research question is: Does using a retraction cord make a difference for gum health as opposed to not using one? Participants will be assigned into four separate groups. Two groups will receive a restoration with one type of bonding material, either with or without a retraction cord. The other two groups will receive a restoration with a different kind of bonding material, either with or without a retraction cord.
Researchers will check gum health status before the restorations and again on days 1, 7, and 28. They will observe symptoms such as swelling in the gums, bleeding of the gums, and gum margin positions. A fluid sample from the area between the gum and tooth will be collected to test for molecules of inflammation.
Detailed description
Study Rationale Retraction cord is commonly used during composite resin restoration of non-carious cervical lesions to control gingival crevicular fluid and improve visibility. Its effect on periodontal health in this specific application has not been well characterized. This study compares clinical periodontal parameters and gingival crevicular fluid (GCF) biomarker levels with and without cord placement.
Study Design This is a randomized, tooth-level (split-mouth), double-blind clinical trial following a 2×2 factorial design: adhesive system (G-Premio Bond vs. 3M Scotchbond Universal Plus) × retraction cord use (with vs. without). Eligible participants had multiple qualifying lesions, allowing individual teeth to be randomly allocated by coin-flip to different groups within the same participant. The participants and the examiner performing periodontal measurements were blinded to group allocation.
Procedures All restorations were placed by a single operator. In cord groups, an Ultrapak retraction cord was placed in the gingival sulcus before adhesive application and left in situ throughout the restorative procedure. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Keratinized Tissue Width, relative gingival margin position) and GCF samples were collected at baseline and on days 1, 7, and 28 after restoration. GCF biomarkers (TNF-α, IL-8, MMP-8, TIMP-1, PGE-2, LXA-4) were quantified using enzyme-linked immunosorbent assay (ELISA).
Enrollment Twelve participants (69 teeth) were initially enrolled; the study was completed with 10 participants (57 teeth) following two withdrawals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: G-Premio Bond, No Cord | Active comparator | Device: Composite Resin Restorative, Device: Universal Adhesive - G-Premio BondComposite resin restoration of non-carious cervical lesions using 3M Filtek Easy Match Universal Restorative with G-Premio Bond adhesive, without retraction cord placement. |
| Group 2: G-Premio Bond + Retraction Cord | Experimental | Device: Gingival Retraction Cord, Device: Composite Resin Restorative, Device: Universal Adhesive - G-Premio BondComposite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement. |
| Group 3: Scotchbond Universal Plus, No Cord | Active comparator | Device: Composite Resin Restorative, Device: Universal Adhesive - Scotchbond Universal PlusComposite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement. |
| Group 4: Scotchbond Universal Plus + Retraction Cord | Experimental | Device: Gingival Retraction Cord, Device: Composite Resin Restorative, Device: Universal Adhesive - Scotchbond Universal PlusComposite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, with Ultrapak retraction cord placed in the gingival sulcus before restoration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Systemically healthy
- Non-smoker
- Periodontally healthy (whole-mouth bleeding on probing <10%, mean probing pocket depth ≤3 mm, mean Plaque Index and Gingival Index ≤1.1)
- At least 20 teeth in occlusion (full/near-full dentition)
Key exclusion criteria (6 listed)
- Presence of systemic disease
- Use of medication known to affect inflammatory response during the study period
- Inability or unwillingness to comply with follow-up visits
- Pregnancy or lactation
- Current smoking
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 |
|---|---|---|
| Gingival Retraction CordA knitted retraction cord placed in the gingival sulcus prior to composite restoration to displace gingival tissue and control gingival crevicular fluid during the bonding procedure. | Device | Group 2: G-Premio Bond + Retraction Cord, Group 4: Scotchbond Universal Plus + Retraction Cord |
| Composite Resin Restorativeanofilled resin composite used for restoration of non-carious cervical lesions in all study groups. | Device | Group 1: G-Premio Bond, No Cord, Group 2: G-Premio Bond + Retraction Cord, Group 3: Scotchbond Universal Plus, No Cord, Group 4: Scotchbond Universal Plus + Retraction Cord |
| Universal Adhesive - G-Premio BondSingle-component universal adhesive system used for bonding the composite restoration to tooth structure. | Device | Group 1: G-Premio Bond, No Cord, Group 2: G-Premio Bond + Retraction Cord |
| Universal Adhesive - Scotchbond Universal PlusUniversal adhesive system used for bonding the composite restoration to tooth structure. | Device | Group 3: Scotchbond Universal Plus, No Cord, Group 4: Scotchbond Universal Plus + Retraction Cord |
Primary outcome
Change in Split-Mouth Gingival Index Difference (ΔGI) Over Time
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Difference in Gingival Index (Löe \& Silness) between cord-treated and no-cord teeth within the same participant (split-mouth design), assessed at each time point. The Gingival Index (Löe \& Silness) ranges from 0 to 3, where 0 indicates healthy gingiva and 3 indicates severe inflammation; higher scores indicate a worse outcome.
11 secondary outcomes
Change in Plaque Index (PI)
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Bleeding on Probing (BOP)
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Probing Pocket Depth (PPD)
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Keratinized Tissue Width (KTW)
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Relative Gingival Margin Position
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Tumor Necrosis Factor-alpha (TNF-α) Concentration
Time frame: Baseline (before restoration), and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Interleukin-8 (IL-8) Concentration
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Concentration
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Concentration
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Prostaglandin E2 (PGE-2) Concentration
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Change in Gingival Crevicular Fluid Lipoxin A4 (LXA-4) Concentration
Time frame: Baseline, and Days 1, 7, and 28 after restoration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to the absence of a formal data-sharing infrastructure. De-identified data may be made available from the corresponding author upon reasonable request for legitimate academic purposes.
Related trials for Tooth Abrasion
Active, not recruiting
Clinical Evaluation of Resin Infiltration Treatment of MIH-affected Teeth in Pediatric Patients
Molar Incisor Hypomineralization
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.
Ali Cekici, DDS, PhD principal investigator
Istanbul University
Safa Tuncer, DDS, PhD study chair
Istanbul University
Mehmet Cenkay Aydın, DDS study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival Retraction Cord, Composite Resin Restorative and Universal Adhesive - G-Premio Bond in people with Tooth Abrasion and Gingival Recessions, run by Istanbul 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 4 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Split-Mouth Gingival Index Difference (ΔGI) Over Time (time frame: Baseline, and Days 1, 7, and 28 after restoration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.