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

Endodontically-Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04258696
• Other study ID #: CEBD-CU-2019-09-30
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: Alaa Omara, M.D.s
• Phone: 01025238079
• Email: alaa.abdelzaher[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Broken Teeth Injury With Complication
• Endodontically-Treated Teeth
• Spacing of Anterior Maxillary Teeth
• Tooth Injuries
• Tooth, Nonvital

Intervention

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. suf?cient epithelium will be removed to place the impression material and visualize the ?nishing line. The tissue will be kept moist with water during the procedure then impression will be taken
• 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

Locations

Country	Name	City	State
Egypt	Alaa Abdelzaher Abdelhamid Omara	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Amount of lateral tissue displacement	Measured using Stereomicroscope	through study completion,up to 24 weeks
Secondary	Amount of vertical tissue displacement	Measured using Stereomicroscope	through study completion,up to 24 weeks