Gingival Crevicular Fluid, Gingival Inflammation, Gingival Recessions, Non-Carious Cervical Lesions (NCCLs), Periodontal Health, Tooth Abrasion
Conditions
Keywords
Non-Carious Cervical Lesion, Retraction Cord, Gingival Crevicular Fluid, Composite Resin Restoration, Periodontal Health
Brief 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 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.
Interventions
DEVICEGingival Retraction Cord
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.
DEVICEComposite Resin Restorative
anofilled resin composite used for restoration of non-carious cervical lesions in all study groups.
DEVICEUniversal Adhesive - G-Premio Bond
Single-component universal adhesive system used for bonding the composite restoration to tooth structure.
DEVICEUniversal Adhesive - Scotchbond Universal Plus
Universal adhesive system used for bonding the composite restoration to tooth structure.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Split-Mouth Gingival Index Difference (ΔGI) Over Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plaque Index (PI) | Baseline, and Days 1, 7, and 28 after restoration | 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. |
| Change in Bleeding on Probing (BOP) | Baseline, and Days 1, 7, and 28 after restoration | Percentage of probed sites showing bleeding on gentle periodontal probing. |
| Change in Probing Pocket Depth (PPD) | Baseline, and Days 1, 7, and 28 after restoration | Distance from the gingival margin to the base of the periodontal pocket, measured in millimeters with a periodontal probe. |
| Change in Keratinized Tissue Width (KTW) | Baseline, and Days 1, 7, and 28 after restoration | Width of keratinized gingiva, measured in millimeters from the gingival margin to the mucogingival junction. |
| Change in Relative Gingival Margin Position | Baseline, and Days 1, 7, and 28 after restoration | Position of the gingival margin relative to a fixed reference point, used to assess gingival recession or coronal displacement. |
| Change in Gingival Crevicular Fluid Tumor Necrosis Factor-alpha (TNF-α) Concentration | Baseline (before restoration), and Days 1, 7, and 28 after restoration | TNF-α concentration in gingival crevicular fluid (GCF) samples, quantified using enzyme-linked immunosorbent assay (ELISA), compared across treatment groups over time. |
| Change in Gingival Crevicular Fluid Interleukin-8 (IL-8) Concentration | Baseline, and Days 1, 7, and 28 after restoration | IL-8 concentration in gingival crevicular fluid, quantified using ELISA. |
| Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Concentration | Baseline, and Days 1, 7, and 28 after restoration | MMP-8 concentration in gingival crevicular fluid, quantified using ELISA. |
| Change in Gingival Crevicular Fluid Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Concentration | Baseline, and Days 1, 7, and 28 after restoration | TIMP-1 concentration in gingival crevicular fluid, quantified using ELISA. |
| Change in Gingival Crevicular Fluid Prostaglandin E2 (PGE-2) Concentration | Baseline, and Days 1, 7, and 28 after restoration | PGE-2 concentration in gingival crevicular fluid, quantified using ELISA. |
| Change in Gingival Crevicular Fluid Lipoxin A4 (LXA-4) Concentration | Baseline, and Days 1, 7, and 28 after restoration | LXA-4 concentration in gingival crevicular fluid, quantified using ELISA. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAli Cekici, DDS, PhD
Istanbul University
STUDY_CHAIRSafa Tuncer, DDS, PhD
Istanbul University
STUDY_DIRECTORMehmet Cenkay Aydın, DDS
Istanbul University
Outcome results
None listed