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Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes

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ClinicalTrials.gov Identifier: NCT03816930
Recruitment Status : Active, not recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Beyza Ünalan Değirmenci, Yuzuncu Yıl University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periodontal Disease Gingival Disease Procedure: mechanical cord usage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : January 17, 2020
Estimated Study Completion Date : April 17, 2020

Arm Intervention/treatment
Active Comparator: Mechanical cord usage
Mechanical retraction
Procedure: mechanical cord usage
Due to the retraction procedures, same preparation conditions will be obtained.
Other Names:
  • Chemical contained retraction usage
  • MZ-6 laser tip used throughing

Active Comparator: Chemical contained retraction usage
Chemical retraction
Procedure: mechanical cord usage
Due to the retraction procedures, same preparation conditions will be obtained.
Other Names:
  • Chemical contained retraction usage
  • MZ-6 laser tip used throughing

Active Comparator: MZ-6 laser tip used throughing
Laser retraction
Procedure: mechanical cord usage
Due to the retraction procedures, same preparation conditions will be obtained.
Other Names:
  • Chemical contained retraction usage
  • MZ-6 laser tip used throughing




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT03816930


Locations
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Turkey
Beyza Ünalan Değirmenci
Van, Turkey, 65080
Sponsors and Collaborators
Yuzuncu Yıl University

Publications of Results:
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Responsible Party: Beyza Ünalan Değirmenci, Assistant Professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03816930     History of Changes
Other Study ID Numbers: 05
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Beyza Ünalan Değirmenci, Yuzuncu Yıl University:
CAD/CAM
Gingival retraction

Additional relevant MeSH terms:
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Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases