NCT05949073

The Impact of Retraction Cords on the Gingival Margin Level.

The Impact of Retraction Cords Used in Fixed Prosthodontics on the Gingival Margin Level in Humans: A Clinical Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the relationship between placing specific retraction cord for different periods of time and the post-operative gingival margin level in humans. Determining the amount of immediate reversible and delayed irreversible gingival recession (vertical gingival retraction) that might happen after placing a retraction cord around a natural tooth in healthy humans. It also aims to investigate the impact of mechanical and chemo-mechanical gingival retraction on periodontal health.

Detailed description

Dental impression is the communication tool between the dentist and the dental technician during the fabrication of fixed dental prosthesis, capturing a precise impression of the prepared tooth and the finish line is mandatory to ensure the perfect fitting of the final prosthesis. Atraumatic gingival displacement is performed to provide sufficient both lateral and vertical space between the finish line and the gingival tissue that will allow recording adequate amount of unprepared tooth structure with the least distortion of impression material as well as minimal damage to attachment apparatus of the tooth as maintaining a healthy periodontium is an important factor in the survival of any fixed prosthesis. The gingival recession that might happen after soft tissue displacement may jeopardize treatment success in esthetic areas of the mouth. Knowledge about the soft tissue reaction to one of the most common gingival displacement methods (retraction cords) is critical yet limited. Also, there is a gap in knowledge about the safety of retraction cords when used for multiple teeth preparations and would then be left in the sulcus for an extended amount of time, as well as the potential harm they can do in terms of persistent gingival recession. The purpose of this study is to examine the relationship between placing specific retraction cords for different periods of time and the post-operative gingival margin level in humans. Determining the amount of immediate reversible and delayed irreversible gingival recession (vertical gingival retraction) that might happen after placing a retraction cord around a natural tooth in healthy humans. It also aims to investigate the impact of mechanical and chemo-mechanical gingival retraction on periodontal health. This clinical study is expected to be useful for dental clinicians who use retraction cords during restorative procedures (cervical composite restorations) or for fixed prostheses; awareness about the amount of transient and permanent gingival recession that could occur is important to avoid undesirable effects such as esthetic issues and/or sensitivity.

Conditions

• Gingival Retraction
• Gingival Recession
• Periodontal Health

Interventions

Type	Name	Description
PROCEDURE	Non-impregnated retraction cords/ less than 10 minutes	lower first molar will be prepared for full coverage restoration, plain retraction cord will be placed in the sulcus just before impression recording (less than 10 minutes).
PROCEDURE	Non-impregnated retraction cords/ more than 10 minutes	the preparation of the lower first molar for full coverage restoration will be initiated - occlusal reduction, contact points breaking, and preparation with the roughest bur- then a plain retraction cord will be placed and kept in the sulcus until finishing the preparation and impression recording which will take more than 10 minutes.
DRUG	impregnated gingival retraction cord - less than 10 minutes	lower first molar will be prepared for full coverage restoration, Aluminum chloride-impregnated retraction cord will be placed in the sulcus just before impression recording (less than 10 minutes).
DRUG	impregnated gingival retraction cord - more than 10 minutes	the preparation of the lower first molar for full coverage restoration will be initiated - occlusal reduction, contact points breaking, and preparation with the roughest bur- then an Aluminum chloride-impregnated retraction cord will be placed and kept in the sulcus until finishing the preparation and impression recording which will take more than 10 minutes.

Timeline

• Start date: 2023-07-25
• Primary completion: 2023-12-01
• Completion: 2024-05-01
• First posted: 2023-07-17
• Last updated: 2023-09-06

Locations

1 site across 1 country: Jordan