NCT03816930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2020

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

January 17, 2019

Last Update Submit

April 21, 2021

Conditions

Keywords

CAD/CAMGingival retraction

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-12 months

Study Arms (3)

Mechanical cord usage

ACTIVE COMPARATOR

Mechanical retraction

Procedure: mechanical cord usage

Chemical contained retraction usage

ACTIVE COMPARATOR

Chemical retraction

Procedure: mechanical cord usage

MZ-6 laser tip used throughing

ACTIVE COMPARATOR

Laser retraction

Procedure: mechanical cord usage

Interventions

Due to the retraction procedures, same preparation conditions will be obtained.

Also known as: Chemical contained retraction usage, MZ-6 laser tip used throughing
Chemical contained retraction usageMZ-6 laser tip used throughingMechanical cord usage

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being systemically healthy
  • To indicate crown restoration in mandibular molar teeth
  • To be vital to the preparation of the crown of the teeth

You may not qualify if:

  • Systemically unhealthy individuals
  • Endodontic treatment of mandibular molar teeth
  • Mandibular molar female individuals drawn for various reasons
  • Pregnant women
  • Periodontally unhealthy individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beyza Ünalan Değirmenci

Van, 65080, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

MeSH Terms

Conditions

Periodontal DiseasesGingival Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 25, 2019

Study Start

January 17, 2019

Primary Completion

January 17, 2020

Study Completion

April 17, 2020

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations