Clinical trial NCT05949073: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Retraction
Gingival Recession
Periodontal Health
Keywords: retraction cords
gingival recession
periodontal health
gingival retraction
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The amount of irreversible gingival recession that might happen after gingival retraction.
timeFrame: 4 weeks
Secondary outcomes:
measure: The impact of retraction cords on periodontal health.
timeFrame: 4 weeks
measure: The level of patient's discomfort.
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: the University of Jordan
Study officials:
affiliation: University of Jordan
name: Ahmad Mahmoud, Phd
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.