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.
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
- Conditions the study is for
- This Study Will be Performed to Evaluate the Efficiency of 810 nm Diode Laser Disinfection on Periapical Healing in Root Canal Retreatment Cases
- 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.
Egypt1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Group I (Diode laser group) | Experimental | Laser 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) | Experimental | Calcium 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.
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.
- First posted26 Sep 2025
- Study start19 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
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 This Study Will be Performed to Evaluate the Efficiency of 810 nm Diode Laser Disinfection on Periapical Healing in Root Canal Retreatment CasesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabah Morad Sobhy, Al-Azhar University
- Investigators
- Sabah M Sobhy, PHD, Principal investigator, Al-Azhar UniversityEman M. Hassan, Study director, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egyp
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 38878107Morsy 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07194837
- Acronym / sponsor ID
- Retreatment / P-PD-25-27
- Keywords
- disinfection, retreatment, 810 diode laser
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Sep 2025 (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.
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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Diode laser group) | Experimental | Device: diode laserLaser 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 |
| Group II (Calcium hydroxide group) | Experimental | Other: Calcium Hydroxide (Ca(OH)2)Calcium 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients who had received antibiotic therapy within the past month.
- Pregnancy and lactation.
- Systemic disease.
- Physical or mental disability.
- Non restorable teeth.
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 laser810 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. | Device | Group I (Diode laser group) |
| Calcium Hydroxide (Ca(OH)2)Calcium hydroxide paste (MetaBiomed, Chungcheongbuk-do, Korea) will be placed inside the root canal and left for 1 week. | Other | Group II (Calcium hydroxide group) |
Primary outcome
periapical healing at 1 year follow-up
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 38878107Dogan 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.
- 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.
- Individual participant dataSharing planned: No
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.
Sabah M Sobhy, PHD principal investigator
Al-Azhar University
Eman M. Hassan study director
Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egyp
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 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.