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This Study Will be Performed to Evaluate the Efficiency of 810 nm Diode Laser Disinfection on Periapical Healing in Root Canal Retreatment CasesRetreatmentNCT07194837

The Efficiency of 810 nm Diode Laser on Periapical Healing After Root Canal Retreatment

A study testing diode laser and Calcium Hydroxide (Ca(OH)2) in people with This Study Will be Performed to Evaluate the Efficiency of 810 nm Diode Laser Disinfection on Periapical Healing in Root Canal Retreatment Cases, run by Al-Azhar University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main cause of endodontic disorders is microbial infection. From the infected root canal, microorganisms can penetrate into the deeper layers of root dentine and propagate a periapical tissue through the apical foramen and lateral canals. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
What is being tested?
diode laser and Calcium Hydroxide (Ca(OH)2)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
19 Sep 2025to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients have single rooted teeth with root canal form type I.
  • Have previous endodontic therapy with failure.
  • Have periapical radiolucency (PAI score of 3 or 4).
  • Patients who provide written informed consent.

Who cannot join

  • Patients who had received antibiotic therapy within the past month.
  • Pregnancy and lactation.
  • Systemic disease.
  • Physical or mental disability.
  • Non restorable teeth.
  • Any signs of resorption, immature roots, fracture, perforation.
  • Bone metabolism disease and/or patients using drugs that affect bone metabolism (such as steroids and bisphosphonates)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sabah M. Sobhy, PHD contact

+201096529143

sabamorad@yahoo.com

Sabah M. Sobhy, PHD contact

01096529143

sabamorad@yahoo.com

Egypt1 site, 1 recruiting
  • from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University

    Cairo

    Sabah M. Sobhy, PHD, 01096529143, sabamorad@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: The Efficiency of 810 nm Diode Laser on Periapical Healing After Root Canal Retreatment Using Cone Beam Computed Tomography: A Randomized Controlled Clinical Trial

The main cause of endodontic disorders is microbial infection. From the infected root canal, microorganisms can penetrate into the deeper layers of root dentine and propagate a periapical tissue through the apical foramen and lateral canals. Eliminating microorgnims is the primary objective of endodontics in order to create an environment as free of bacteria as possible. This will favor the environment for healing without the need of periapical surgery in some resistant cases.

Disinfection in root canal retreatment (RCR) is much more difficult because persistent microorganisms have settled in the root canal. The resistant periapical lesions result from resistant bacteria to antimicrobial agents. They can survive for years around the filled root canals. Sodium hypochlorite (NaOCl) is the most widely used irrigant in root canal therapy due to its strong antibacterial effect and its ability to dissolve organic substances. Effective canal cleaning is difficult to achieve without the use of NaOCl at a sufficiently high concentration. However, NaOCl has several drawbacks, including its cytotoxicity which can lead to tissue damage and patient symptoms. Additionally, its strong oxidizing nature negatively affects the mechanical properties of dentin such as microhardness and elastic modulus. NaOCl should be used with caution in endodontic procedures to prevent hypochlorite accidents.

Read more

Calcium hydroxide (Ca (OH)2) is the most widely utilized intracanal medication. It has the potential to dissolve tissue, acts as a physical barrier and generates hydroxyl ions, creating an extremely alkaline environment. It has been shown to be quite effective in the treatment of teeth with persistent periapical lesions. To provide optimal endodontic treatment, the root canal system should be thoroughly cleaned of soft-tissue debris, smear layer, and bacteria. However, it is impossible to completely disinfect and clean debris that build up. That is why, adjunctive aids, such as the use of passive ultrasonic and sonic activation of the irrigant and lasers with varying wave lengths, have been introduced during conventional endodontic therapy in cleaning maneuvers.

[ Laser therapy for root canal disinfection has gained popularity since laser-assisted root canal treatment aims to remove the smear layer, penetrate deep into dentin and eliminate bacteria up to 1000 μm . Laser types have been shown to reduce bacterial load when used as an adjunct to conventional root canal treatment such as Nd:YAG , Er:YAG and diode laser . Diode laser exhibits a powerful antibacterial effect by altering the bacterial cell wall and damaging the cell membrane. Its photothermal action targets accessible bacteria, while its photodisruptive properties affect those in less accessible areas. This mechanism may not cause immediate bacterial death but instead induces sublethal damage that inhibits bacterial growth. By compromising the integrity of the cell wall and causing the accumulation of denatured proteins, bacterial growth is halted, eventually leading to cell lysis. These effects are achieved with minimal does of heat . Researches have demonstrated differing degrees of effectiveness in achieving root canal disinfection with the use of diode lasers.

Diode laser is highly well-suited for root canal therapy due to its infrared wavelength and the use of a thin, flexible optic fiber tip (200 µm), which enables deep penetration into the root canal system. This design allows for efficient delivery and distribution of laser energy, improving disinfection and reducing microbial load. Furthermore, the compact size and affordability of diode lasers make them practical for use in general dental clinics and increasing their adoption in routine endodontic procedures. A study demonstrated that 980nm diode laser achieved bactericidal effect ranging from 77 to 97% in root canals infected with E. faecalis using energy outputs of 1.7, 2.3 and 2.8 W. Antimicrobial effect was related to the amount of energy and dentin thickness. Furthermore, several studies have confirmed that diode laser can serve as an adjunct to conventional root canal therapy in cases with necrotic pulp and periapical radiolucency because of the bactericidal effect, the ability to penetrate through the dentinal thickness, and the ability to vaporize soft tissues .

Radiographic examination provides essential information on post-treatment periapical healing, where the absence of periapical radiolucency remains a primary marker of successful therapy. Intraoral digital periapical radiograph remains the most widely used imaging modality in endodontics due to their accessibility and reliability. These radiographs provide valuable insights into dentoalveolar structures, allowing clinicians to assess root morphology, canal anatomy, and quality of the treatment. However, the primary limitation lies in its two-dime

Read the detailed description

Cone beam computed tomography (CBCT) has become a cornerstone in endodontic imaging, providing high-resolution, three-dimensional visualization of complex anatomical structures. CBCT enhances diagnostic precision and treatment planning beyond what is achievable with two-dimensional radiograph. It has been shown to be more accurate than digital periapical radiographs in the long-term assessment of root canal treat¬ment success. Moreover, CBCT demonstrates high accuracy in determining the volume of periapical pathosis making it a valuable tool in periapical healing evaluation. Therefore, this study aims to evaluate the effect of 810 nm diode laser on periapical healing after root canal retreatment in failed endodontic cases with chronic periapical lesion using CBCT. The null hypothesis is that there is no difference in periapical healing between the tested groups following root canal retreatment.

Being tested
diode laser, Calcium Hydroxide (Ca(OH)2)
Keywords
disinfection, retreatment, 810 diode laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diode laserDevice

    810 nm diode laser (Elexxion clarosdental laser, Singen Deutschland, Germany) in a continuous wave mode with a power of 1.5 Watts in 4 cycles of 5 seconds with 20 seconds intervals in between each.

  • Calcium Hydroxide (Ca(OH)2)Other

    Calcium hydroxide paste (MetaBiomed, Chungcheongbuk-do, Korea) will be placed inside the root canal and left for 1 week.

Study groups in NCT07194837
Study groupRoleWhat they receive
Group I (Diode laser group)ExperimentalLaser activated disinfection will be performed using 810 nm diode laser (Elexxion clarosdental laser, Singen Deutschland, Germany) in a continuous wave mode with a power of 1.5 Watts in 4 cycles of 5 seconds with 20 seconds intervals in between each. Prior to irradiation, all the individuals in the room will wear protective laser safety eye glasses. A 200 μm fiber optic tip (Lite medics, Italy) will be inserted 1 mm from the working length, activated and moved in slow helical motion from the apex to the cervical third with alternating between clockwise and counterclockwise direction at speed of about 2 mm/s(23). 5 ml saline solution will be used for each application and finally before tooth restoration temporarily with light cure glass ionomer resin cement. After 1 week, the temporary filling will be removed following local anaesthesia and isolation, the root canal will be irrigated with 5 ml saline. Then, the root canal system will be obturated using ADSEAL resin-based
Receives: Device: diode laser
Group II (Calcium hydroxide group)ExperimentalCalcium hydroxide paste (MetaBiomed, Chungcheongbuk-do, Korea) will be placed inside the root canal and left for 1 week. The access cavity will be temporarily sealed with light cure glass ionomer resin cement. After 1 week, the temporary filling will be removed following local anaesthesia and isolation, the root canal will be irrigated with 20 ml saline and gently filed using H file corresponding to the master apical file size. Root canal obturation and final coronal restoration will be completed as in group I.
Receives: Other: Calcium Hydroxide (Ca(OH)2)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. periapical healing at 1 year follow-up

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start19 Sep 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07194837
Sponsor's protocol ID
P-PD-25-27
Acronym
Retreatment
Status last verified
Sep 2025
First submitted
19 Sep 2025
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dogan MU, Aricioglu B, Kose TE, Cikman AS, Oksuzer MC. Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled Trial. Clin Oral Investig. 2024 Jun 15;28(7):376. doi: 10.1007/s00784-024-05758-4.

    PubMed 38878107
  • 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 31372210

Questions about this trial

What is this clinical trial studying?

A study testing diode laser and Calcium Hydroxide (Ca(OH)2) in people with This Study Will be Performed to Evaluate the Efficiency of 810 nm Diode Laser Disinfection on Periapical Healing in Root Canal Retreatment Cases, run by Al-Azhar 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 7 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sabah M. Sobhy, PHD (+201096529143, sabamorad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

periapical healing at 1 year follow-up (time frame: 1 year). 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 NCT07194837, 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 30 Sep 2025.

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