Endodontically-Treated TeethNCT04258696
Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser
A study testing diode laser and ultrapak Knitted retraction cord in people with Endodontically-Treated Teeth and Spacing of Anterior Maxillary Teeth, run by Cairo University at 1 site in Egypt.
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". Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Endodontically-Treated Teeth, Spacing of Anterior Maxillary Teeth, Broken Teeth Injury With Complication
- What is being tested?
- diode laser and ultrapak Knitted retraction cord
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Omaima Elmahalawy, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Alaa Abdelzaher Abdelhamid Omara
Giza
Alaa Omara, M.D.S, 01025238079, alaa.abdelzaher@dentistry.cu.edu.eg
About this study
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
- Being tested
- diode laser, ultrapak Knitted retraction cord
- Keywords
- Gingival retraction, Gingival displacement, Diode laser
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laserDevice
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
ultrapak Knitted retraction cordDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Gingival retraction by ultrapak retraction cord | Active comparator | Not described Receives: Device: ultrapak Knitted retraction cord |
| Gingival retraction by diode laser | Experimental | Not described Receives: Device: diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of lateral tissue displacement
Measured using Stereomicroscope
Measured: through study completion,up to 24 weeks
Secondary outcomes (1)
Amount of vertical tissue displacement
Measured using Stereomicroscope
Measured: through study completion,up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically-Treated TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelzaher Abdelhamid Omara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258696
- Sponsor's protocol ID
- CEBD-CU-2019-09-30
- Status last verified
- Feb 2020
- First submitted
- 1 Nov 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser
- ClinicalTrials.gov ID
- NCT04258696
- Acronym / sponsor ID
- CEBD-CU-2019-09-30
- Conditions
- Endodontically-Treated Teeth, Spacing of Anterior Maxillary Teeth, Broken Teeth Injury With Complication
- Keywords
- Gingival retraction, Gingival displacement, Diode laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingival retraction by ultrapak retraction cord | Active comparator | Device: ultrapak Knitted retraction cord |
| Gingival retraction by diode laser | Experimental | Device: diode laser |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 .
Key exclusion criteria (8 listed)
- Patients with poor oral hygiene.
- Patients with thin gingival biotype.
- Pregnant women.
- Unmotivated patients.
- Patients with gingival recession.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diode laserusing 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 | Device | Gingival retraction by diode laser |
| ultrapak Knitted retraction cordusing 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 | Device | Gingival retraction by ultrapak retraction cord |
Primary outcome
Amount of lateral tissue displacement
Time frame: through study completion,up to 24 weeks
Measured using Stereomicroscope
1 secondary outcome
Amount of vertical tissue displacement
Time frame: through study completion,up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omaima Elmahalawy, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diode laser and ultrapak Knitted retraction cord in people with Endodontically-Treated Teeth and Spacing of Anterior Maxillary Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Omara, M.D.s (01025238079, alaa.abdelzaher@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of lateral tissue displacement (time frame: through study completion,up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.