The Impact of Retraction Cords on the Gingival Margin Level.

Not Applicable

Recruiting

• Conditions: Gingival Retraction; Gingival Recession; Periodontal Health
• Interventions: Procedure: Non-impregnated retraction cords/ less than 10 minutes; Procedure: Non-impregnated retraction cords/ more than 10 minutes; Drug: impregnated gingival retraction cord - less than 10 minutes; Drug: impregnated gingival retraction cord - more than 10 minutes

• Registration Number: NCT05949073
• Lead Sponsor: University of Jordan

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-17
• Study Start: 2023-07-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2023-12-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age of 18-50 years
2. Systemically healthy no history of medical disease
3. Volunteers should have a lower first molar indicated for full coverage restoration, of healthy periodontium with an antagonist tooth and proximal contacts.
4. Gingival index score 0,1
5. Plaque index score 0,1
6. Probing depth ≤3 mm
7. No bleeding on probing.

Exclusion Criteria

1. Gingival and periodontal disease
2. Pregnancy and lactation
3. History of systemic diseases such as hypertension, diabetes mellitus, HIV, bone metabolic disorders, radiation therapy, and cancer.
4. History of prolonged use of steroids/immunosuppressive agents/aspirin/anticoagulant/other medications.
5. Heavy Smoking.
6. Deleterious habits.
7. Teeth with high scalloped margins, keratinized tissue less than 2 mm, fibrotic gingival tissue, gingival recession, pocket formation deeper than 3mm.
8. Teeth with thick flat gingival phenotype.
9. Teeth with Sub-gingival caries or restoration at the buccal surface.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non impregnated gingival retraction cord - less than 10 minutes	Non-impregnated retraction cords/ less than 10 minutes	Non impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes.
Non impregnated gingival retraction cord - more than 10 minutes	Non-impregnated retraction cords/ more than 10 minutes	Non impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.
impregnated gingival retraction cord - less than 10 minutes	impregnated gingival retraction cord - less than 10 minutes	Impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes.
impregnated gingival retraction cord - more than 10 minutes	impregnated gingival retraction cord - more than 10 minutes	Impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.

Primary Outcome Measures

Name	Time	Method
The amount of irreversible gingival recession that might happen after gingival retraction.	4 weeks	The amount of reversible and irreversible gingival recession (vertical gingival retraction) that might occur in healthy humans after placing retraction cords around prepared teeth for different periods of time. This will be measured after recording multiple digital intraoral scans pre-operative, 1 week, and 4 weeks post-operative using Medit i-700 then they will be superimposed using Medit Design tool (previously known as Medit compare) to track the vertical location of the gingival margin.

Secondary Outcome Measures

Name	Time	Method
The level of patient's discomfort.	Immediately after the intervention	The patient's level of discomfort will be recorded using the Numerical Rating Scale.
The impact of retraction cords on periodontal health.	4 weeks	The impact on periodontal health will be measured by recording the periodontal indices pre-operative, 1-week, and 4 weeks post-operative by a single-blinded periodontist.

Trial Locations

Locations (1)

the University of Jordan; 🇯🇴 Amman, Jordan