The Effect of Retraction Cord on the Surrounding Periodontal Tissues in Restorative Treatment

NCT07734935 | Completed FDA Device

• 2 other identifiers: 2024/802025-008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Carious Cervical Lesions (NCCLs); Periodontal Health; Tooth Abrasion; Gingival Recessions; Gingival Crevicular Fluid; Gingival Inflammation

Keywords

Non-Carious Cervical Lesion; Retraction Cord; Gingival Crevicular Fluid; Composite Resin Restoration; Periodontal Health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, and Days 1, 7, and 28 after restoration

Secondary Outcomes (11)

• Change in Plaque Index (PI)

  Baseline, and Days 1, 7, and 28 after restoration

• Change in Bleeding on Probing (BOP)

  Baseline, and Days 1, 7, and 28 after restoration

• Change in Probing Pocket Depth (PPD)

  Baseline, and Days 1, 7, and 28 after restoration

• Change in Keratinized Tissue Width (KTW)

  Baseline, and Days 1, 7, and 28 after restoration

• Change in Relative Gingival Margin Position

  Baseline, and Days 1, 7, and 28 after restoration

Study Arms (4)

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.

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.

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.

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.

Device: Gingival Retraction Cord; Device: Composite Resin Restorative; Device: Universal Adhesive - Scotchbond Universal Plus

Interventions

Gingival Retraction Cord DEVICE

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.

Group 2: G-Premio Bond + Retraction Cord; Group 4: Scotchbond Universal Plus + Retraction Cord

Composite Resin Restorative DEVICE

anofilled resin composite used for restoration of non-carious cervical lesions in all study groups.

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 Bond DEVICE

Single-component universal adhesive system used for bonding the composite restoration to tooth structure.

Group 1: G-Premio Bond, No Cord; Group 2: G-Premio Bond + Retraction Cord

Universal Adhesive - Scotchbond Universal Plus DEVICE

Universal adhesive system used for bonding the composite restoration to tooth structure.

Group 3: Scotchbond Universal Plus, No Cord; Group 4: Scotchbond Universal Plus + Retraction Cord

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, 34116, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Abrasion; Gingival Recession; Gingivitis

Condition Hierarchy (Ancestors)

Tooth Wear; Tooth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Infections

Study Officials

• Ali Cekici, DDS, PhD

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Safa Tuncer, DDS, PhD

  Istanbul University

  STUDY CHAIR

• Mehmet Cenkay Aydın, DDS

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start: February 18, 2025
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)