The Impact of Retraction Cords on the Gingival Margin Level.

• ClinicalTrials.gov Identifier: NCT05949073
• Recruitment Status: Recruiting
• First Posted: July 17, 2023
• Last Update Posted: September 6, 2023
• Sponsor: University of Jordan
• Information provided by (Responsible Party): Majdoleen Fouad, University of Jordan

Tracking Information

• First Submitted Date: June 14, 2023
• First Posted Date: July 17, 2023
• Last Update Posted Date: September 6, 2023
• Actual Study Start Date: July 25, 2023
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2023)

The amount of irreversible gingival recession that might happen after gingival retraction. [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2023)

• The impact of retraction cords on periodontal health. [ Time Frame: 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.
• The level of patient's discomfort. [ Time Frame: Immediately after the intervention ]
  The patient's level of discomfort will be recorded using the Numerical Rating Scale.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Impact of Retraction Cords on the Gingival Margin Level.
• Official Title: The Impact of Retraction Cords Used in Fixed Prosthodontics on the Gingival Margin Level in Humans: A Clinical Study.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Gingival Retraction
• Gingival Recession
• Periodontal Health

Intervention

• 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).
  Other Name: Aluminum chloride-impregnated retraction cords.
• 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.
  Other Name: Aluminum chloride-impregnated retraction cord

Study Arms

• Active Comparator: Non impregnated gingival retraction cord - less than 10 minutes
  Non impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes.
  Intervention: Procedure: Non-impregnated retraction cords/ less than 10 minutes
• Active Comparator: Non impregnated gingival retraction cord - more than 10 minutes
  Non impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.
  Intervention: Procedure: Non-impregnated retraction cords/ more than 10 minutes
• Active Comparator: 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.
  Intervention: Drug: impregnated gingival retraction cord - less than 10 minutes
• Active Comparator: 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.
  Intervention: Drug: impregnated gingival retraction cord - more than 10 minutes

Publications *

• Al Hamad KQ, Azar WZ, Alwaeli HA, Said KN. A clinical study on the effects of cordless and conventional retraction techniques on the gingival and periodontal health. J Clin Periodontol. 2008 Dec;35(12):1053-8. doi: 10.1111/j.1600-051X.2008.01335.x.
• Ruel J, Schuessler PJ, Malament K, Mori D. Effect of retraction procedures on the periodontium in humans. J Prosthet Dent. 1980 Nov;44(5):508-15. doi: 10.1016/0022-3913(80)90069-4.
• Sarmento HR, Leite FR, Dantas RV, Ogliari FA, Demarco FF, Faot F. A double-blind randomised clinical trial of two techniques for gingival displacement. J Oral Rehabil. 2014 Apr;41(4):306-13. doi: 10.1111/joor.12142. Epub 2014 Jan 22.
• Feng J, Aboyoussef H, Weiner S, Singh S, Jandinski J. The effect of gingival retraction procedures on periodontal indices and crevicular fluid cytokine levels: a pilot study. J Prosthodont. 2006 Mar-Apr;15(2):108-12. doi: 10.1111/j.1532-849X.2006.00083.x.
• Einarsdottir ER, Lang NP, Aspelund T, Pjetursson BE. A multicenter randomized, controlled clinical trial comparing the use of displacement cords, an aluminum chloride paste, and a combination of paste and cords for tissue displacement. J Prosthet Dent. 2018 Jan;119(1):82-88. doi: 10.1016/j.prosdent.2017.03.010. Epub 2017 May 5.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 14, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2024
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Majdoleen Fouad, Msc; +962799019839; majdoleenfouad8@gmail.com

Contact: Mohammad Al-Rabab'ah, Phd; +962792131548; malrababah@ju.edu.jo

• Listed Location Countries: Jordan

Administrative Information

• NCT Number: NCT05949073
• Other Study ID Numbers: Retraction cords
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Majdoleen Fouad, University of Jordan
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Jordan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ahmad Mahmoud, Phd; University of Jordan

• PRS Account: University of Jordan
• Verification Date: September 2023