Endodontically Treated TeethNCT05603988
Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression
A study testing Intracanal Diode laser irradiation in people with Endodontically Treated Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
This clinical trial will be conducted to evaluate the amount of Il-8 expression before and after the application of intracanal irradiation with diode laser 980 nm versus placebo in failed endodontic cases with periapical lesions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Intracanal Diode laser irradiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2021to 27 Apr 2022
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- failed previously treated endodontic single-rooted teeth with chronic periapical lesions; with radiographic evidence of periapical radiolucency of not less than 1 cm diameter will be selected.
- Teeth with straight root canals.
- No contributory medical history.
- No previous administration of analgesics and/or antibiotics within the previous 2 weeks.
Who cannot join
- Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
- Teeth with curved roots.
- Swelling or sinus tract.
- Mutilated teeth that interfere with proper isolation and seal between visits.
- Subjects with generalized periodontitis, or if the tooth has a probing depth of more than 3 mm.
- Subjects with uncontrolled diabetes or debilitating diseases.
- Pregnant or nursing females.
- Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression in Lesions Refractory to Endodontic Treatment: A Randomized Control Trial
This clinical trial will be conducted to evaluate the amount of Il-8 expression before and after the application of intracanal irradiation with diode laser 980 nm versus placebo in failed endodontic cases with periapical lesions.
Read the detailed description
- Thorough medical and dental history for the eligible patients
- Thorough intraoral and extraoral diagnosis
- Local anesthesia
- Isolation and removal of any previous filling or restoration
- Removal of old gutta percha and establish patency to the full working length.
- 1st sample: will be collected using 3 sterile paper points
- Chemo-mechanical preparation.
- 2nd sample collection
- Laser group: The canals will be irradiated with a high-power diode laser, with wavelength of 980 nm, maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter.
- Mock laser application (Placebo group): The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation, but not activated.
- 3rd sample collection
- A piece of dry cotton will be placed in the access cavity, and then will be sealed with glass ionomer filling material
- 2nd visit: 1 week later, 4th sample collection then Obturation
- Number of visits \& follow up period: Two visits
- Conditions
- Endodontically Treated Teeth
- Being tested
- Intracanal Diode laser irradiation, Placebo
- Keywords
- Diode laser, Endodontic retreatment, IL-8 expression
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracanal Diode laser irradiationDevice
After endodontic retreatment, root canals will be irradiated with a 980 nm diode laser coupled with optical fibre 200 μm (Litemedics, Italy) with setting 1.2-watt power, in pulsed mode. The irradiation protocol will be of 5-sec irradiation followed by a 10-sec pause, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth. The tip will be positioned 1 mm short of the apex. Followed by activation during which it will be slowly dragged at a speed of approximately 2 mm/ sec in a way that the root canals will be irradiated from the apical to the coronal portion, in a helicoidal movement touching the canal walls.
PlaceboOther
After endodontic retreatment, mock laser application (Placebo group) will be applied:
The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | • Mock laser application (Placebo group): The fiber optic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated Receives: Other: Placebo |
| Diode Laser group | Other | Intracanal Diode laser application Receives: Device: Intracanal Diode laser irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantification of IL-8
- After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before (S-1), after chemo-mechanical preparation (S-2), after intracanal irradiation or placebo effect (S-3) and last after one week of the treatment (S-4). The kit is used according to the manufacturer's recommendations.
Measured: one week
Secondary outcomes (1)
Postoperative pain
Following the first visit, the modified visual analogue scale (VAS scale) with 11 points where 0 means no pain and 10 means maximum pain will be used to record patient's level of pain
Measured: 6, 12, 24 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start14 Apr 2021
- Primary completion22 Mar 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ahmed Morsy, Cairo University
- Investigators
- Dina A Morsy, lecturer, Principal investigator, Cairo UniversitySherif A Elkhodary, assoc. Prof, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603988
- Sponsor's protocol ID
- DAMorsy
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morsy DA, Negm M, Diab A, Ahmed G. Postoperative pain and antibacterial effect of 980 nm diode laser versus conventional endodontic treatment in necrotic teeth with chronic periapical lesions: A randomized control trial. F1000Res. 2018 Nov 15;7:1795. doi: 10.12688/f1000research.16794.1. eCollection 2018.
PubMed 31372210Kamma JJ, Vasdekis VG, Romanos GE. The effect of diode laser (980 nm) treatment on aggressive periodontitis: evaluation of microbial and clinical parameters. Photomed Laser Surg. 2009 Feb;27(1):11-9. doi: 10.1089/pho.2007.2233.
PubMed 19196111
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression in Lesions Refractory to Endodontic Treatment: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05603988
- Acronym / sponsor ID
- DAMorsy
- Conditions
- Endodontically Treated Teeth
- Keywords
- Diode laser, Endodontic retreatment, IL-8 expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 3 Nov 2022 (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.
This clinical trial will be conducted to evaluate the amount of Il-8 expression before and after the application of intracanal irradiation with diode laser 980 nm versus placebo in failed endodontic cases with periapical lesions.
Detailed description
- Thorough medical and dental history for the eligible patients
- Thorough intraoral and extraoral diagnosis
- Local anesthesia
- Isolation and removal of any previous filling or restoration
- Removal of old gutta percha and establish patency to the full working length.
- 1st sample: will be collected using 3 sterile paper points
- Chemo-mechanical preparation.
- 2nd sample collection
- Laser group: The canals will be irradiated with a high-power diode laser, with wavelength of 980 nm, maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter.
- Mock laser application (Placebo group): The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation, but not activated.
- 3rd sample collection
- A piece of dry cotton will be placed in the access cavity, and then will be sealed with glass ionomer filling material
- 2nd visit: 1 week later, 4th sample collection then Obturation
- Number of visits \& follow up period: Two visits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Placebo• Mock laser application (Placebo group): The fiber optic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated |
| Diode Laser group | Other | Device: Intracanal Diode laser irradiationIntracanal Diode laser application |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- failed previously treated endodontic single-rooted teeth with chronic periapical lesions; with radiographic evidence of periapical radiolucency of not less than 1 cm diameter will be selected.
- Teeth with straight root canals.
- No contributory medical history.
- No previous administration of analgesics and/or antibiotics within the previous 2 weeks.
Key exclusion criteria (8 listed)
- Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
- Teeth with curved roots.
- Swelling or sinus tract.
- Mutilated teeth that interfere with proper isolation and seal between visits.
- Subjects with generalized periodontitis, or if the tooth has a probing depth of more than 3 mm.
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 |
|---|---|---|
| Intracanal Diode laser irradiationAfter endodontic retreatment, root canals will be irradiated with a 980 nm diode laser coupled with optical fibre 200 μm (Litemedics, Italy) with setting 1.2-watt power, in pulsed mode. The irradiation protocol will be of 5-sec irradiation followed by a 10-sec pause, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth. The tip will be positioned 1 mm short of the apex. Followed by activation during which it will be slowly dragged at a speed of approximately 2 mm/ sec in a way that the root canals will be irradiated from the apical to the coronal portion, in a helicoidal movement touching the canal walls. | Device | Diode Laser group |
| PlaceboAfter endodontic retreatment, mock laser application (Placebo group) will be applied: The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated | Other | Placebo group |
Primary outcome
quantification of IL-8
Time frame: one week
- After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before (S-1), after chemo-mechanical preparation (S-2), after intracanal irradiation or placebo effect (S-3) and last after one week of the treatment (S-4). The kit is used according to the manufacturer's recommendations.
1 secondary outcome
Postoperative pain
Time frame: 6, 12, 24 hours and 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 31372210Morsy DA, Negm M, Diab A, Ahmed G. Postoperative pain and antibacterial effect of 980 nm diode laser versus conventional endodontic treatment in necrotic teeth with chronic periapical lesions: A randomized control trial. F1000Res. 2018 Nov 15;7:1795. doi: 10.12688/f1000research.16794.1. eCollection 2018.
- Results publication: PubMed 19196111Kamma JJ, Vasdekis VG, Romanos GE. The effect of diode laser (980 nm) treatment on aggressive periodontitis: evaluation of microbial and clinical parameters. Photomed Laser Surg. 2009 Feb;27(1):11-9. doi: 10.1089/pho.2007.2233.
- Individual participant dataSharing planned: No
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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.
Dina A Morsy, lecturer principal investigator
Cairo University
Sherif A Elkhodary, assoc. Prof principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracanal Diode laser irradiation in people with Endodontically Treated 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 4 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: finished, as of the sponsor's last update on 21 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantification of IL-8 (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603988, which also lists 2 linked publications.
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 21 Aug 2023.