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The Impact of Retraction Cords on the Gingival Margin Level.

Primary Purpose

Gingival Retraction, Gingival Recession, Periodontal Health

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
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
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Retraction focused on measuring retraction cords, gingival recession, periodontal health, gingival retraction

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • the University of JordanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Non impregnated gingival retraction cord - less than 10 minutes

Non impregnated gingival retraction cord - more than 10 minutes

impregnated gingival retraction cord - less than 10 minutes

impregnated gingival retraction cord - more than 10 minutes

Arm Description

Non impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes.

Non impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.

Impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes.

Impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The level of patient's discomfort.
The patient's level of discomfort will be recorded using the Numerical Rating Scale.

Full Information

First Posted
June 14, 2023
Last Updated
September 4, 2023
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT05949073
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Retraction, Gingival Recession, Periodontal Health
Keywords
retraction cords, gingival recession, periodontal health, gingival retraction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non impregnated gingival retraction cord - less than 10 minutes
Arm Type
Active Comparator
Arm Description
Non impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes.
Arm Title
Non impregnated gingival retraction cord - more than 10 minutes
Arm Type
Active Comparator
Arm Description
Non impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.
Arm Title
impregnated gingival retraction cord - less than 10 minutes
Arm Type
Active Comparator
Arm Description
Impregnated gingival retraction cord will be placed around the prepared tooth and left for less than 10 minutes.
Arm Title
impregnated gingival retraction cord - more than 10 minutes
Arm Type
Active Comparator
Arm Description
Impregnated gingival retraction cord will be placed around the prepared tooth and left for more than 10 minutes.
Intervention Type
Procedure
Intervention Name(s)
Non-impregnated retraction cords/ less than 10 minutes
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Non-impregnated retraction cords/ more than 10 minutes
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
impregnated gingival retraction cord - less than 10 minutes
Other Intervention Name(s)
Aluminum chloride-impregnated retraction cords.
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
impregnated gingival retraction cord - more than 10 minutes
Other Intervention Name(s)
Aluminum chloride-impregnated retraction cord
Intervention Description
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.
Primary Outcome Measure Information:
Title
The amount of irreversible gingival recession that might happen after gingival retraction.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The impact of retraction cords on periodontal health.
Description
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.
Time Frame
4 weeks
Title
The level of patient's discomfort.
Description
The patient's level of discomfort will be recorded using the Numerical Rating Scale.
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Majdoleen Fouad, Msc
Phone
+962799019839
Email
majdoleenfouad8@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Al-Rabab'ah, Phd
Phone
+962792131548
Email
malrababah@ju.edu.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Mahmoud, Phd
Organizational Affiliation
University of Jordan
Official's Role
Study Director
Facility Information:
Facility Name
the University of Jordan
City
Amman
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Majdoleen Fouad
Phone
+962799019839
Email
majdoleenfouad8@gmail.com
First Name & Middle Initial & Last Name & Degree
mohammad al--rabab'ah
Phone
+962792131548
Email
malrababah@ju.edu.jo

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19040582
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.
Results Reference
background
PubMed Identifier
7003108
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.
Results Reference
background
PubMed Identifier
24446590
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.
Results Reference
background
PubMed Identifier
16650011
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.
Results Reference
background
PubMed Identifier
28478985
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.
Results Reference
background

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The Impact of Retraction Cords on the Gingival Margin Level.

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