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

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.

Study Overview

• Status: Unknown
• Conditions: Endodontically-Treated Teeth; Spacing of Anterior Maxillary Teeth; Broken Teeth Injury With Complication
• Intervention / Treatment: Device: ultrapak Knitted retraction cord; Device: diode laser

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Omara, M.D.S; Phone Number: 01025238079; Email: alaa.abdelzaher@dentistry.cu.edu.eg
• Study Contact Backup: Name: Omaima Elmahalawy, professor; Phone Number: 01222154399

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Alaa Abdelzaher Abdelhamid Omara
    • Contact: Alaa Omara, M.D.S; Phone Number: 01025238079; Email: alaa.abdelzaher@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Gingival retraction by ultrapak retraction cord	Device: ultrapak Knitted retraction cord; 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
EXPERIMENTAL: Gingival retraction by diode laser	Device: diode laser; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of lateral tissue displacement	Measured using Stereomicroscope	through study completion,up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of vertical tissue displacement	Measured using Stereomicroscope	through study completion,up to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Pain scale ( 0 - 5 ) 5 means maximum pain, worse outcome , 1 means low pain,better outcome o means no pain	through study completion,up to 24 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 30, 2020
• Primary Completion (ANTICIPATED): October 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Diode laser; Gingival retraction; Gingival displacement
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital; Tooth Injuries
• Other Study ID Numbers: CEBD-CU-2019-09-30

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