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

NCT04258696 | Unknown

• 1 other identifier: CEBD-CU-2019-09-30
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gingival retraction; Gingival displacement; Diode laser

Outcome Measures

Primary Outcomes (1)

• Amount of lateral tissue displacement

  Measured using Stereomicroscope

  through study completion,up to 24 weeks

Secondary Outcomes (1)

• Amount of vertical tissue displacement

  through study completion,up to 24 weeks

Other Outcomes (1)

• Patient satisfaction

  through study completion,up to 24 weeks

Study Arms (2)

Gingival retraction by ultrapak retraction cord

ACTIVE COMPARATOR

Device: ultrapak Knitted retraction cord

Gingival retraction by diode laser

EXPERIMENTAL

Device: diode laser

Interventions

diode laser DEVICE

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

Gingival retraction by diode laser

ultrapak Knitted retraction cord DEVICE

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

Gingival retraction by ultrapak retraction cord

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Alaa Abdelzaher Abdelhamid Omara

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Alaa Omara, M.D.s

CONTACT

01025238079; alaa.abdelzaher@dentistry.cu.edu.eg

Omaima Elmahalawy, professor

CONTACT

01222154399

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer assistant , Fixed Prosthodontics Department ,Faculty of Dentistry

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: February 6, 2020
• Study Start: June 30, 2020
• Primary Completion: October 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

EG (1)