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Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser

Primary Purpose

Endodontically-Treated Teeth, Spacing of Anterior Maxillary Teeth, Broken Teeth Injury With Complication

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
diode laser
ultrapak Knitted retraction cord
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically-Treated Teeth focused on measuring Gingival retraction, Gingival displacement, Diode laser

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
  • Patients able physically and psychologically to tolerate conventional restorative procedures.
  • Patients with no active periodontal disease.
  • Patients with thick gingival biotype.
  • Patients with teeth problems indicated for full coverage restoration .
  • Vital or non vital teeth.
  • Good Oral hygiene.

Exclusion Criteria:

  • Patients with poor oral hygiene.
  • Patients with thin gingival biotype.
  • Pregnant women.
  • Unmotivated patients.
  • Patients with gingival recession.
  • Patients with psychiatric problems or unrealistic expectation .
  • patient suffer from parafunctional habit .
  • Smokers and heavy caffeine consumers.

Sites / Locations

  • Alaa Abdelzaher Abdelhamid OmaraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gingival retraction by ultrapak retraction cord

Gingival retraction by diode laser

Arm Description

Outcomes

Primary Outcome Measures

Amount of lateral tissue displacement
Measured using Stereomicroscope

Secondary Outcome Measures

Amount of vertical tissue displacement
Measured using Stereomicroscope

Full Information

First Posted
November 1, 2019
Last Updated
February 4, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04258696
Brief Title
Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser
Official Title
Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2020 (Anticipated)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
In fixed prosthodontic treatment, deflection of gingival tissues for diagnosis or making an impression is one of the important phases. Gingival displacement is defined as "displacement of gingival tissues both in vertical and lateral dimensions". Lateral retraction displaces the tissues so that an adequate bulk of impression material can be interfaced with the prepared tooth. Vertical retraction exposes the uncut portion of the tooth apical to the finish line Conventional gingival retraction cord technique may injure the healthy epithelial lining and result in postoperative gingival recession The diode laser has been used for displacing gingiva to make a definitive impression. Rather than displacing gingival tissue, it removes the epithelial lining from the sulcus. The aim of the Study is to compare between the Ultrapak retraction cord and diode laser regarding the amount of vertical and lateral retraction and patient comfort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically-Treated Teeth, Spacing of Anterior Maxillary Teeth, Broken Teeth Injury With Complication
Keywords
Gingival retraction, Gingival displacement, Diode laser

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Gingival retraction by ultrapak retraction cord
Arm Type
Active Comparator
Arm Title
Gingival retraction by diode laser
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
diode laser
Intervention Description
using Ultrapak Knitted retraction cord as a gingival retraction method . using Wiser Cordless Dental Diode Laser from Doctor Smile Dental Laser By LAMBDA SpA Italy as a gingival retraction method.• The tip of diode laser, will be angled toward the soft tissue and away from the prepared tooth, will be passed along the gingival sulcus to remove the sulcular epithelium. Constant and steady short brushing strokes gently removed the lining of the sulcus in order to achieve a full 360-degree trough. The tip will be constantly cleaned with a gauze sponge wetted with hydrogen peroxide to remove debris and to eliminate potential bacterial contamination. sufficient epithelium will be removed to place the impression material and visualize the finishing line. The tissue will be kept moist with water during the procedure then impression will be taken
Intervention Type
Device
Intervention Name(s)
ultrapak Knitted retraction cord
Intervention Description
using Ultrapak Knitted retraction cord as a gingival retraction method retraction cord will be applied for 8-10 mins then an impression will be taken , poured to obtain a cast and the die sectioned
Primary Outcome Measure Information:
Title
Amount of lateral tissue displacement
Description
Measured using Stereomicroscope
Time Frame
through study completion,up to 24 weeks
Secondary Outcome Measure Information:
Title
Amount of vertical tissue displacement
Description
Measured using Stereomicroscope
Time Frame
through study completion,up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
Pain scale ( 0 - 5 ) 5 means maximum pain, worse outcome , 1 means low pain,better outcome o means no pain
Time Frame
through study completion,up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided. Patients able physically and psychologically to tolerate conventional restorative procedures. Patients with no active periodontal disease. Patients with thick gingival biotype. Patients with teeth problems indicated for full coverage restoration . Vital or non vital teeth. Good Oral hygiene. Exclusion Criteria: Patients with poor oral hygiene. Patients with thin gingival biotype. Pregnant women. Unmotivated patients. Patients with gingival recession. Patients with psychiatric problems or unrealistic expectation . patient suffer from parafunctional habit . Smokers and heavy caffeine consumers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Omara, M.D.s
Phone
01025238079
Email
alaa.abdelzaher@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Omaima Elmahalawy, professor
Phone
01222154399
Facility Information:
Facility Name
Alaa Abdelzaher Abdelhamid Omara
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa Omara, M.D.S
Phone
01025238079
Email
alaa.abdelzaher@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser

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