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Status unknownNCT04258696Updated Feb 6, 2020

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

An interventional study of diode laser and ultrapak Knitted retraction cord in Endodontically-Treated Teeth, Spacing of Anterior Maxillary Teeth and Broken Teeth Injury With Complication, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
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Study 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.

02

Conditions studied

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

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Keywords

  • Gingival retraction
  • Gingival displacement
  • Diode laser
03

In context

Tooth, Nonvital

113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.

This study's planned enrollment of 22 is below the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
22 participants (estimated)

Study arms

  • Active comparator
    Gingival retraction by ultrapak retraction cord

    Device: ultrapak Knitted retraction cord

  • Experimental
    Gingival retraction by diode laser

    Device: diode laser

Interventions

  • Devicediode 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

  • Deviceultrapak 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

06

What researchers measure

Primary outcomes

  1. Amount of lateral tissue displacement

    Measured using Stereomicroscope

    Time frame: through study completion,up to 24 weeks

Secondary outcomes

  1. Amount of vertical tissue displacement

    Measured using Stereomicroscope

    Time frame: through study completion,up to 24 weeks

Other outcomes

  1. Patient satisfaction

    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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04258696
Lead sponsor
Cairo University
Responsible party
Alaa Abdelzaher Abdelhamid Omara (Lecturer assistant , Fixed Prosthodontics Department ,Faculty of Dentistry, Cairo University) — Principal investigator
First posted
Feb 6, 2020
Start date
Jun 30, 2020 (estimated)
Primary completion
Oct 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Feb 6, 2020

Study contacts

Alaa Omara, M.D.s
Contact
alaa.abdelzaher@dentistry.cu.edu.eg
01025238079
Omaima Elmahalawy, professor
Contact
01222154399

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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