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

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

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

Interventions

DEVICE

Gingival 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.

DEVICE

Composite Resin Restorative

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

DEVICE

Universal Adhesive - G-Premio Bond

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

DEVICE

Universal Adhesive - Scotchbond Universal Plus

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

Sponsors & Collaborators

• Istanbul University

  lead OTHER

Principal Investigators

• Ali Cekici, DDS, PhD · Istanbul University

• Safa Tuncer, DDS, PhD · Istanbul University

• Mehmet Cenkay Aydın, DDS · Istanbul University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-18

Primary Completion

2025-09-23

Completion

2025-09-23

Countries

• Turkey (Türkiye)

Study Locations