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

Primary Purpose

Periodontal Disease, Gingival Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mechanical cord usage
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Periodontal Disease focused on measuring CAD/CAM, Gingival retraction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beyza Ünalan Değirmenci

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Mechanical cord usage

Chemical contained retraction usage

MZ-6 laser tip used throughing

Arm Description

Mechanical retraction

Chemical retraction

Laser retraction

Outcomes

Primary Outcome Measures

Retraction methods or procedures effects on gingival health
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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2019
Last Updated
April 21, 2021
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT03816930
Brief Title
Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes
Official Title
Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
April 17, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Gingival Disease
Keywords
CAD/CAM, Gingival retraction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanical cord usage
Arm Type
Active Comparator
Arm Description
Mechanical retraction
Arm Title
Chemical contained retraction usage
Arm Type
Active Comparator
Arm Description
Chemical retraction
Arm Title
MZ-6 laser tip used throughing
Arm Type
Active Comparator
Arm Description
Laser retraction
Intervention Type
Procedure
Intervention Name(s)
mechanical cord usage
Other Intervention Name(s)
Chemical contained retraction usage, MZ-6 laser tip used throughing
Intervention Description
Due to the retraction procedures, same preparation conditions will be obtained.
Primary Outcome Measure Information:
Title
Retraction methods or procedures effects on gingival health
Description
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.
Time Frame
3-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Beyza Ünalan Değirmenci
City
Van
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12716328
Citation
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.
Results Reference
result
PubMed Identifier
20882737
Citation
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.
Results Reference
result
PubMed Identifier
11155185
Citation
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.
Results Reference
result
PubMed Identifier
11887594
Citation
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.
Results Reference
result
PubMed Identifier
17319365
Citation
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.
Results Reference
result
PubMed Identifier
8648569
Citation
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.
Results Reference
result
PubMed Identifier
6951037
Citation
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.
Results Reference
result
PubMed Identifier
25917854
Citation
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.
Results Reference
result

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

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