The Impact of Retraction Cords on the Gingival Margin Level.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedSeptember 6, 2023
September 1, 2023
4 months
June 14, 2023
September 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The amount of irreversible gingival recession that might happen after gingival retraction.
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.
4 weeks
Secondary Outcomes (2)
The impact of retraction cords on periodontal health.
4 weeks
The level of patient's discomfort.
Immediately after the intervention
Study Arms (4)
Non impregnated gingival retraction cord - less than 10 minutes
ACTIVE COMPARATORNon 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
ACTIVE COMPARATORNon 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
ACTIVE COMPARATORImpregnated 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
ACTIVE COMPARATORImpregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.
Interventions
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).
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.
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).
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.
Eligibility Criteria
You may qualify if:
- Age of 18-50 years
- Systemically healthy no history of medical disease
- Volunteers should have a lower first molar indicated for full coverage restoration, of healthy periodontium with an antagonist tooth and proximal contacts.
- Gingival index score 0,1
- Plaque index score 0,1
- Probing depth ≤3 mm
- No bleeding on probing.
You may not qualify if:
- Gingival and periodontal disease
- Pregnancy and lactation
- History of systemic diseases such as hypertension, diabetes mellitus, HIV, bone metabolic disorders, radiation therapy, and cancer.
- History of prolonged use of steroids/immunosuppressive agents/aspirin/anticoagulant/other medications.
- Heavy Smoking.
- Deleterious habits.
- Teeth with high scalloped margins, keratinized tissue less than 2 mm, fibrotic gingival tissue, gingival recession, pocket formation deeper than 3mm.
- Teeth with thick flat gingival phenotype.
- Teeth with Sub-gingival caries or restoration at the buccal surface.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the University of Jordan
Amman, Jordan
Related Publications (5)
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.
PMID: 19040582BACKGROUNDRuel 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.
PMID: 7003108BACKGROUNDSarmento 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.
PMID: 24446590BACKGROUNDFeng 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.
PMID: 16650011BACKGROUNDEinarsdottir 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.
PMID: 28478985BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmad Mahmoud, Phd
University of Jordan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postgraduate Student.
Study Record Dates
First Submitted
June 14, 2023
First Posted
July 17, 2023
Study Start
July 25, 2023
Primary Completion
December 1, 2023
Study Completion
May 1, 2024
Last Updated
September 6, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share