- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816930
Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes
April 21, 2021 updated by: Beyza Ünalan Değirmenci, Yuzuncu Yıl University
Clinically, the gingival retraction dentistry itself has found wide uses.
It has achieved the use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative dentistry, management of root caries and root sensitivity, and recently in the use of appropriate measurements to improve the marginal fit of implant prostheses.There are three different retraction procedures described in the literature: mechanical, mechanical-chemical (chemically impregnated cords or matrix in injectable form) and surgery (electrosurgical, laser, cauterization, etc.)The mechanical method of retraction cords is not always suitable for patients' existing pocket depth, the necessity of using different combinations in shallow or deep pockets, the potential for limited bleeding control in chemically impregnated cords and the toxicity values in those who interact with chemical have led researchers to search for alternative methods.
Especially inflammed gingiva is very sensitive to mechanical and chemical trauma.
Studies have reported that gingival inflammation, pain, pocket formation, gingival withdrawal, increased bleeding and wound contamination occurred following retraction cord application.
However, it is a known fact that the impression material is distorted or the accuracy of the measurement is decreased with the measurements taken without retraction.
Nowadays, CAD / CAM (computer-aided design / computer-aided manufacturing) devices, which are designed to overcome these problems and eliminate the errors related to the measurement material, are the first step to be taken with a clear measure.Gingival retraction is recommended to improve the success of scanners in all restorations performed at the gingival or subgingival endpoint.
Therefore, in our study, crown restorations will be produced from hybrid blocks by means of CAD / CAM device in order to evaluate the interaction of gingival health with hybrid blocks and to provide the latest technology and standardization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Van, Turkey, 65080
- Beyza Ünalan Değirmenci
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being systemically healthy
- To indicate crown restoration in mandibular molar teeth
- To be vital to the preparation of the crown of the teeth
Exclusion Criteria:
- Systemically unhealthy individuals
- Endodontic treatment of mandibular molar teeth
- Mandibular molar female individuals drawn for various reasons
- Pregnant women
- Periodontally unhealthy individuals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mechanical cord usage
Mechanical retraction
|
Due to the retraction procedures, same preparation conditions will be obtained.
Other Names:
|
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Active Comparator: Chemical contained retraction usage
Chemical retraction
|
Due to the retraction procedures, same preparation conditions will be obtained.
Other Names:
|
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Active Comparator: MZ-6 laser tip used throughing
Laser retraction
|
Due to the retraction procedures, same preparation conditions will be obtained.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retraction methods or procedures effects on gingival health
Time Frame: 3-12 months
|
Probing depth is one of the criteria that shows the gingival health.
In each control sessions same researcher measure the probing depth as mm via a periodontal probe.
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3-12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Padbury A Jr, Eber R, Wang HL. Interactions between the gingiva and the margin of restorations. J Clin Periodontol. 2003 May;30(5):379-85. doi: 10.1034/j.1600-051x.2003.01277.x.
- Al-Ani A, Bennani V, Chandler NP, Lyons KM, Thomson WM. New Zealand dentists' use of gingival retraction techniques for fixed prosthodontics and implants. N Z Dent J. 2010 Sep;106(3):92-6.
- Goldberg PV, Higginbottom FL, Wilson TG. Periodontal considerations in restorative and implant therapy. Periodontol 2000. 2001;25:100-9. doi: 10.1034/j.1600-0757.2001.22250108.x.
- Kopac I, Cvetko E, Marion L. Gingival inflammatory response induced by chemical retraction agents in beagle dogs. Int J Prosthodont. 2002 Jan-Feb;15(1):14-9.
- Polat NT, Ozdemir AK, Turgut M. Effects of gingival retraction materials on gingival blood flow. Int J Prosthodont. 2007 Jan-Feb;20(1):57-62.
- Ferrari M, Cagidiaco MC, Ercoli C. Tissue management with a new gingival retraction material: a preliminary clinical report. J Prosthet Dent. 1996 Mar;75(3):242-7. doi: 10.1016/s0022-3913(96)90479-5.
- de Gennaro GG, Landesman HM, Calhoun JE, Martinoff JT. A comparison of gingival inflammation related to retraction cords. J Prosthet Dent. 1982 Apr;47(4):384-6. doi: 10.1016/s0022-3913(82)80085-1.
- Ahmed SN, Donovan TE. Gingival displacement: Survey results of dentists' practice procedures. J Prosthet Dent. 2015 Jul;114(1):81-5.e1-2. doi: 10.1016/j.prosdent.2014.11.015. Epub 2015 Apr 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2019
Primary Completion (Actual)
January 17, 2020
Study Completion (Actual)
April 17, 2020
Study Registration Dates
First Submitted
January 17, 2019
First Submitted That Met QC Criteria
January 23, 2019
First Posted (Actual)
January 25, 2019
Study Record Updates
Last Update Posted (Actual)
April 22, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.