The Impact of Retraction Cords on the Gingival Margin Level.
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ClinicalTrials.gov Identifier: NCT05949073 |
Recruitment Status :
Recruiting
First Posted : July 17, 2023
Last Update Posted : September 6, 2023
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Condition or disease | Intervention/treatment | Phase |
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Gingival Retraction Gingival Recession Periodontal Health | 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 | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Impact of Retraction Cords Used in Fixed Prosthodontics on the Gingival Margin Level in Humans: A Clinical Study. |
Actual Study Start Date : | July 25, 2023 |
Estimated Primary Completion Date : | December 1, 2023 |
Estimated Study Completion Date : | May 1, 2024 |
Arm | Intervention/treatment |
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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.
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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). |
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.
|
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. |
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.
|
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. |
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.
|
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 |
- 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.
- 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.
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05949073
Contact: Majdoleen Fouad, Msc | +962799019839 | majdoleenfouad8@gmail.com | |
Contact: Mohammad Al-Rabab'ah, Phd | +962792131548 | malrababah@ju.edu.jo |
Jordan | |
the University of Jordan | Recruiting |
Amman, Jordan | |
Contact: Majdoleen Fouad +962799019839 majdoleenfouad8@gmail.com | |
Contact: mohammad al--rabab'ah +962792131548 malrababah@ju.edu.jo |
Study Director: | Ahmad Mahmoud, Phd | University of Jordan |
Responsible Party: | Majdoleen Fouad, Postgraduate Student., University of Jordan |
ClinicalTrials.gov Identifier: | NCT05949073 |
Other Study ID Numbers: |
Retraction cords |
First Posted: | July 17, 2023 Key Record Dates |
Last Update Posted: | September 6, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
retraction cords gingival recession periodontal health gingival retraction |
Gingival Recession Gingival Diseases Periodontal Diseases |
Mouth Diseases Stomatognathic Diseases Periodontal Atrophy |