Gingival RetractionNCT05949073
The Impact of Retraction Cords on the Gingival Margin Level.
A study testing Non-impregnated retraction cords/ less than 10 minutes, Non-impregnated retraction cords/ more than 10 minutes and impregnated gingival retraction cord - less than 10 minutes in people with Gingival Retraction and Gingival Recession, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Retraction, Gingival Recession, Periodontal Health
- What is being tested?
- Non-impregnated retraction cords/ less than 10 minutes, Non-impregnated retraction cords/ more than 10 minutes and impregnated gingival retraction cord - less than 10 minutes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 25 Jul 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
the University of Jordan
Amman
Majdoleen Fouad, +962799019839, majdoleenfouad8@gmail.com
mohammad al--rabab'ah, +962792131548, malrababah@ju.edu.jo
About this study
Official title: The Impact of Retraction Cords Used in Fixed Prosthodontics on the Gingival Margin Level in Humans: A Clinical Study.
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.
Read the 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.
- Conditions
- Gingival Retraction, Gingival Recession, Periodontal Health
- Being tested
- Non-impregnated retraction cords/ less than 10 minutes, Non-impregnated retraction cords/ more than 10 minutes, impregnated gingival retraction cord - less than 10 minutes, impregnated gingival retraction cord - more than 10 minutes
- Keywords
- retraction cords, gingival recession, periodontal health, gingival retraction
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-impregnated retraction cords/ less than 10 minutesProcedure or surgery
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).
Non-impregnated retraction cords/ more than 10 minutesProcedure or surgery
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.
impregnated gingival retraction cord - less than 10 minutesDrug
Also called Aluminum chloride-impregnated retraction cords.
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).
impregnated gingival retraction cord - more than 10 minutesDrug
Also called Aluminum chloride-impregnated retraction cord
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.
| Study group | Role | What they receive |
|---|---|---|
| Non impregnated gingival retraction cord - less than 10 minutes | Active comparator | Non impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes. Receives: Procedure: Non-impregnated retraction cords/ less than 10 minutes |
| Non impregnated gingival retraction cord - more than 10 minutes | Active comparator | Non impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes. Receives: Procedure: Non-impregnated retraction cords/ more than 10 minutes |
| impregnated gingival retraction cord - less than 10 minutes | Active comparator | Impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes. Receives: Drug: impregnated gingival retraction cord - less than 10 minutes |
| impregnated gingival retraction cord - more than 10 minutes | Active comparator | Impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes. Receives: Drug: impregnated gingival retraction cord - more than 10 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
The impact of retraction cords on periodontal health.
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.
Measured: 4 weeks
The level of patient's discomfort.
The patient's level of discomfort will be recorded using the Numerical Rating Scale.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start25 Jul 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gingival RetractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Majdoleen Fouad, University of Jordan
- Investigators
- Ahmad Mahmoud, Phd, Study director, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949073
- Sponsor's protocol ID
- Retraction cords
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19040582Ruel 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.
PubMed 7003108Sarmento 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.
PubMed 24446590Feng 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.
PubMed 16650011Einarsdottir 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.
PubMed 28478985
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Retraction Cords Used in Fixed Prosthodontics on the Gingival Margin Level in Humans: A Clinical Study.
- ClinicalTrials.gov ID
- NCT05949073
- Acronym / sponsor ID
- Retraction cords
- Conditions
- Gingival Retraction, Gingival Recession, Periodontal Health
- Keywords
- retraction cords, gingival recession, periodontal health, gingival retraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non impregnated gingival retraction cord - less than 10 minutes | Active comparator | Procedure: Non-impregnated retraction cords/ less than 10 minutesNon 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 comparator | Procedure: Non-impregnated retraction cords/ more than 10 minutesNon 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 comparator | Drug: impregnated gingival retraction cord - less than 10 minutesImpregnated 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 comparator | Drug: impregnated gingival retraction cord - more than 10 minutesImpregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-impregnated retraction cords/ less than 10 minuteslower 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 or surgery | Non impregnated gingival retraction cord - less than 10 minutes |
| Non-impregnated retraction cords/ more than 10 minutesthe 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. | Procedure or surgery | Non impregnated gingival retraction cord - more than 10 minutes |
| impregnated gingival retraction cord - less than 10 minutesAlso: Aluminum chloride-impregnated retraction cords.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). | Drug | impregnated gingival retraction cord - less than 10 minutes |
| impregnated gingival retraction cord - more than 10 minutesAlso: Aluminum chloride-impregnated retraction cordthe 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. | Drug | impregnated gingival retraction cord - more than 10 minutes |
Primary outcome
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.
2 secondary outcomes
The impact of retraction cords on periodontal health.
Time frame: 4 weeks
The level of patient's discomfort.
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 19040582Al 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.
- Background: PubMed 7003108Ruel 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.
- Background: PubMed 24446590Sarmento 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.
- Background: PubMed 16650011Feng 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.
- Background: PubMed 28478985Einarsdottir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Mahmoud, Phd study director
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-impregnated retraction cords/ less than 10 minutes, Non-impregnated retraction cords/ more than 10 minutes and impregnated gingival retraction cord - less than 10 minutes in people with Gingival Retraction and Gingival Recession, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Majdoleen Fouad, Msc (+962799019839, majdoleenfouad8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of irreversible gingival recession that might happen after gingival retraction. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05949073, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.