Pulpitis - IrreversibleZn-OO/MTAPNCT06854744
Zinc Oxide Ozonated Olive Oil in LSTR
A study testing lesion sterlization and tissue repair, Zinc Oxide Ozonated Oil and Modified Triple Antibiotic Paste in people with Pulpitis - Irreversible and Ozone, run by Tanta University at 2 sites in Egypt.
Trial summary
This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible, Ozone, Pulp Disease, Dental
- What is being tested?
- lesion sterlization and tissue repair, Zinc Oxide Ozonated Oil and Modified Triple Antibiotic Paste
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jan 2024to Apr 2025
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Physiologic root resorption is more than one-third of its length.
- Excessive internal resorption.
- Non-restorable teeth exhibiting greater than grade I mobility.
- Perforation into the bifurcation.
- Any underlying pathological lesion.
- Any previous history of allergy to the antibiotics used in the study. -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Nouran Esmail Mohamed Shalaby
Menouf, +20
esmail shalaby, +20 01018710314, PG_167682@dent.tanta.edu.eg
shimaa sh el-desouky, professor
- Recruiting
Faculty of dentistry Tanta university
Tanta, Gharbia Governorate, +20
nouran esmail shalaby, +20 01018710314, PG_167682@dent.tanta.edu.eg
shimaa sh el-desouky, professor
About this study
Official title: Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
Read the detailed description
Preservation of primary dentition is crucial for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss, especially of the primary second molar, can cause several problems. The first permanent molars typically erupt mesially as a result, leading to some problems including the ectopic eruption of the second premolar, the loss of space for the succeeding permanent teeth and functional impairment 1.
Dental caries is the most prevalent non-communicable disease in children with significant aesthetic, functional, and quality of life deterioration2. Caries lesions can jeopardize the teeth' vitality, as their progression cause infection, pain, and even early tooth loss 2,3. Thus, timely intervention is key to avoid unfavorable repercussions for the child. Depending on the depth of caries (which may have pulp involvement), two approaches may be considered in the primary dentition: vital pulp therapy (VPT) or non-vital therapy (NPT)2,4.
When the pulp can be recovered, VPT may be an option and three options are available: indirect pulp treatment (IPT), direct pulp cap (DPC), and pulpotomy 2-6.
When the caries lesion progresses to the point where the pulp necrotizes, then an NPT is performed, such as a pulpectomy 4. It is a nonvital treatment (NVT), a root canal treatment with irreversibly inflamed or necrotic pulp resulting from caries or trauma 2,4,6,7. Pulpectomy has been the gold-standard treatment for primary teeth with pulp necrosis or irreversible pulp inflammation and is based on the debridement of the root canals with manual or rotary instruments together with the use of antimicrobial irrigation solutions to decontaminate the root canal system for posterior filling with resorbable materials 8 However, the inherent characteristics of the root canal system in primary teeth make this procedure an endodontic challenge, especially in molars 9,10.
In the 1990s, an innovative procedure called lesion sterilization and tissue repair (LSTR) was proposed as an alternative biologic approach that was thought to facilitate the disinfection of dentinal carious lesions, pulp, and periapical lesions in primary teeth 11-13 with the advantages of being simpler and faster 14,15.
The LSTR is a minimally invasive endodontic therapy method that involves the introduction of an antibiotic combination in a propylene glycol vehicle to disinfect root canal systems and periapical lesions 16. It is also known as no instrumental endodontic treatment (NIET) 17. The rationale of LSTR is that combination of three antibiotics (3Mix) can sterilize necrotic pulps and infected root dentine of primary teeth. In primary dentition, LSTR has shown a high rate of clinical success as a substitute for pulpectomy 14,18.
A single antibiotic is insufficient to eradicate pathogenic flora; hence a combination of drugs popularly known as ''triple antibiotic paste'' (TAP) is recommended. This mix is potently active against a wide range of bacteria. It aids in disinfecting and sterilizing the root canal system. It also allows the entry and growth of new tissue in the radicular area in regenerative therapy in the case of young, immature teeth. TAP can also assist in the development of a discipline that will allow for the successful application of other desired and necessary therapies 19,20.
Most commonly, a combination of three broad-spectrum antibiotics, namely, ciprofloxacin, metronidazole and minocycline are used for root canal disinfection. Metronidazole acts against obligate anaerobes, which are the most commonly isolated species from infected root canals. Minocycline is a bacteriostatic long-acting antibiotic, potent against a wide range of microorganisms. Ciprofloxacin is added to eradicate Gram-negative species21,22.
The use of cefaclor (a second-generation cephalosporin) instead of minocycline and ornidazole instead of metronidazole in 3Mix improves clinical outcomes 23,24.
Cruz et al. 25 showed that the incorporation of propylene glycol and macrogol (MP) as a carrier vehicle dramatically raised the penetration of these drugs.
Herbal and natural extracts employed in dentistry as irrigants and intracanal medicaments have gained popularity in recent decades because of their antimicrobial activity, biocompatibility, and anti-inflammatory and anti-oxidant properties 26.
New generations of disinfecting agents have been developed among them is ozone, which is a powerful oxidizing agent and can be used to eliminate bacteria in root canals 27.
Ozone's antibacterial impact gets triggered by oxygenated radicals in aqueous solutions, this will cause changes in the osmotic permeability of the cell membranes resulting in cell damage 28. Ozone is not only an antimicrobial agent, but it can also enhance blood circulation and immune response. It can modulate the cellular and humoral immune system of the patient by the proliferation of immunocompetent cells and the synthesis of immunoglobulins. It can stimulate the phagocytosis process, activate the macrophages, and increase the sensitivity of microorganisms to macrophages29.
There are multiple forms for the application of ozone as ozone gas, ozonated water, and ozonated oil that are used for root canal irrigation and as intra-canal medicaments to obtain disinfection of root canal systems. Ozonated water and olive oil act by entrapping ozone and then emitting it 30.
Nowadays, ozone is utilized in the manufacturing of ozonated olive oil (Oleozon), which is increasingly being utilized as a clinical therapeutic agent for wound healing 31.
Olive oil has anti-inflammatory and antibacterial properties, mainly due to its fatty acid's oleic acid and linoleic acid, and its polyphenol compounds, such as hydroxytyrosol, tyrosol, oleuropein, and oleocanthal 32.
Up to our knowledge, no previous studies discussed Zinc oxide-ozonated olive oil as pulp capping material in non-vital primary molars.
Thus, the main purpose of this study is to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil versus Modified Triple Antibiotic Paste (MTAP) utilizing LSTR technique in the treatment of non-vital primary molars.
- Conditions
- Pulpitis - Irreversible, Ozone, Pulp Disease, Dental, Primary Teeth
- Being tested
- lesion sterlization and tissue repair, Zinc Oxide Ozonated Oil, Modified Triple Antibiotic Paste
- Keywords
- ZnOO /MTAP
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lesion sterlization and tissue repairProcedure or surgery
Also called zinc oxide ozonated oil and modified triple antibiotic paste
evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars.
Zinc Oxide Ozonated OilOther
Zinc Oxide Ozonated Oil
Modified Triple Antibiotic PasteOther
Modified Triple Antibiotic Paste
| Study group | Role | What they receive |
|---|---|---|
| Zinc Oxide Ozonated Oil | Experimental | Zinc Oxide Ozonated Oil as a Lesion Sterilization and Tissue Repair Technique in Primary Molars Receives: Procedure: lesion sterlization and tissue repair; Other: Zinc Oxide Ozonated Oil |
| Modified Triple Antibiotic Paste | Experimental | Modified Triple Antibiotic Paste (MTAP)as a Lesion Sterilization and Tissue Repair Technique in Primary Molars Receives: Procedure: lesion sterlization and tissue repair; Other: Modified Triple Antibiotic Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary out come
.evaluate clinical outcomes including Absence of pain or tenderness, No tooth mobility, and Presence of healthy soft tissue; no swelling, redness, or sinus tract for both groups including zinc oxide ozonated oil group and MTAP group during the follow-up periods 3,6,9,12 months follow up evaluate radiographic effect of both materials on: Continuity of lamina Dura, Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency., No newly formed radiographic lesion, Absence of pathological root resorption, and Evidence of bone regeneration utilizing gray value
Measured: 3,6,9,12 months
primary outcome
evaluate radiograhic effect of both materials on :
- Continuity of lamina Dura.
- Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency.
- No newly formed radiographic lesion.
- Absence of pathological root resorption
- Evidence of bone regeneration utilizatig gray value
Measured: 3,6,9,12 months follow up
Secondary outcomes (1)
secondary out come
evaluate lesion sterlization and tissue repair by (Zn-OO)as a substitute to pulpectomy
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start15 Jan 2024
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- 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
- Model description
- This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Esmail Mohamed Shalaby, Tanta University
- Investigators
- Shaimaa Sh El-Desokey, Professor, Principal investigator, Faculty of dentistry Tanta university , tantaFatma el hendawy, Professor, Study director, Faculty of dentistry Tanta university , TantaNancy metwally, doctor, Study director, Faculty of dentistry Tanta university , Tanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854744
- Sponsor's protocol ID
- 10-23-2093
- Acronym
- Zn-OO/MTAP
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
- ClinicalTrials.gov ID
- NCT06854744
- Acronym / sponsor ID
- Zn-OO/MTAP / 10-23-2093
- Conditions
- Pulpitis - Irreversible, Ozone, Pulp Disease, Dental, Primary Teeth
- Keywords
- ZnOO /MTAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 3 Mar 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.
This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
Detailed description
Preservation of primary dentition is crucial for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss, especially of the primary second molar, can cause several problems. The first permanent molars typically erupt mesially as a result, leading to some problems including the ectopic eruption of the second premolar, the loss of space for the succeeding permanent teeth and functional impairment 1.
Dental caries is the most prevalent non-communicable disease in children with significant aesthetic, functional, and quality of life deterioration2. Caries lesions can jeopardize the teeth' vitality, as their progression cause infection, pain, and even early tooth loss 2,3. Thus, timely intervention is key to avoid unfavorable repercussions for the child. Depending on the depth of caries (which may have pulp involvement), two approaches may be considered in the primary dentition: vital pulp therapy (VPT) or non-vital therapy (NPT)2,4.
When the pulp can be recovered, VPT may be an option and three options are available: indirect pulp treatment (IPT), direct pulp cap (DPC), and pulpotomy 2-6.
When the caries lesion progresses to the point where the pulp necrotizes, then an NPT is performed, such as a pulpectomy 4. It is a nonvital treatment (NVT), a root canal treatment with irreversibly inflamed or necrotic pulp resulting from caries or trauma 2,4,6,7. Pulpectomy has been the gold-standard treatment for primary teeth with pulp necrosis or irreversible pulp inflammation and is based on the debridement of the root canals with manual or rotary instruments together with the use of antimicrobial irrigation solutions to decontaminate the root canal system for posterior filling with resorbable materials 8 However, the inherent characteristics of the root canal system in primary teeth make this procedure an endodontic challenge, especially in molars 9,10.
In the 1990s, an innovative procedure called lesion sterilization and tissue repair (LSTR) was proposed as an alternative biologic approach that was thought to facilitate the disinfection of dentinal carious lesions, pulp, and periapical lesions in primary teeth 11-13 with the advantages of being simpler and faster 14,15.
The LSTR is a minimally invasive endodontic therapy method that involves the introduction of an antibiotic combination in a propylene glycol vehicle to disinfect root canal systems and periapical lesions 16. It is also known as no instrumental endodontic treatment (NIET) 17. The rationale of LSTR is that combination of three antibiotics (3Mix) can sterilize necrotic pulps and infected root dentine of primary teeth. In primary dentition, LSTR has shown a high rate of clinical success as a substitute for pulpectomy 14,18.
A single antibiotic is insufficient to eradicate pathogenic flora; hence a combination of drugs popularly known as ''triple antibiotic paste'' (TAP) is recommended. This mix is potently active against a wide range of bacteria. It aids in disinfecting and sterilizing the root canal system. It also allows the entry and growth of new tissue in the radicular area in regenerative therapy in the case of young, immature teeth. TAP can also assist in the development of a discipline that will allow for the successful application of other desired and necessary therapies 19,20.
Most commonly, a combination of three broad-spectrum antibiotics, namely, ciprofloxacin, metronidazole and minocycline are used for root canal disinfection. Metronidazole acts against obligate anaerobes, which are the most commonly isolated species from infected root canals. Minocycline is a bacteriostatic long-acting antibiotic, potent against a wide range of microorganisms. Ciprofloxacin is added to eradicate Gram-negative species21,22.
The use of cefaclor (a second-generation cephalosporin) instead of minocycline and ornidazole instead of metronidazole in 3Mix improves clinical outcomes 23,24.
Cruz et al. 25 showed that the incorporation of propylene glycol and macrogol (MP) as a carrier vehicle dramatically raised the penetration of these drugs.
Herbal and natural extracts employed in dentistry as irrigants and intracanal medicaments have gained popularity in recent decades because of their antimicrobial activity, biocompatibility, and anti-inflammatory and anti-oxidant properties 26.
New generations of disinfecting agents have been developed among them is ozone, which is a powerful oxidizing agent and can be used to eliminate bacteria in root canals 27.
Ozone's antibacterial impact gets triggered by oxygenated radicals in aqueous solutions, this will cause changes in the osmotic permeability of the cell membranes resulting in cell damage 28. Ozone is not only an antimicrobial agent, but it can also enhance blood circulation and immune response. It can modulate the cellular and humoral immune system of the patient by the proliferation of immunocompetent cells and the synthesis of immunoglobulins. It can stimulate the phagocytosis process, activate the macrophages, and increase the sensitivity of microorganisms to macrophages29.
There are multiple forms for the application of ozone as ozone gas, ozonated water, and ozonated oil that are used for root canal irrigation and as intra-canal medicaments to obtain disinfection of root canal systems. Ozonated water and olive oil act by entrapping ozone and then emitting it 30.
Nowadays, ozone is utilized in the manufacturing of ozonated olive oil (Oleozon), which is increasingly being utilized as a clinical therapeutic agent for wound healing 31.
Olive oil has anti-inflammatory and antibacterial properties, mainly due to its fatty acid's oleic acid and linoleic acid, and its polyphenol compounds, such as hydroxytyrosol, tyrosol, oleuropein, and oleocanthal 32.
Up to our knowledge, no previous studies discussed Zinc oxide-ozonated olive oil as pulp capping material in non-vital primary molars.
Thus, the main purpose of this study is to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil versus Modified Triple Antibiotic Paste (MTAP) utilizing LSTR technique in the treatment of non-vital primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
| Arm | Type | Receives |
|---|---|---|
| Zinc Oxide Ozonated Oil | Experimental | Procedure: lesion sterlization and tissue repair, Other: Zinc Oxide Ozonated OilZinc Oxide Ozonated Oil as a Lesion Sterilization and Tissue Repair Technique in Primary Molars |
| Modified Triple Antibiotic Paste | Experimental | Procedure: lesion sterlization and tissue repair, Other: Modified Triple Antibiotic PasteModified Triple Antibiotic Paste (MTAP)as a Lesion Sterilization and Tissue Repair Technique in Primary Molars |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| lesion sterlization and tissue repairAlso: zinc oxide ozonated oil and modified triple antibiotic pasteevaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars. | Procedure or surgery | Modified Triple Antibiotic Paste, Zinc Oxide Ozonated Oil |
| Zinc Oxide Ozonated OilZinc Oxide Ozonated Oil | Other | Zinc Oxide Ozonated Oil |
| Modified Triple Antibiotic PasteModified Triple Antibiotic Paste | Other | Modified Triple Antibiotic Paste |
Primary outcome
primary out come
Time frame: 3,6,9,12 months
.evaluate clinical outcomes including Absence of pain or tenderness, No tooth mobility, and Presence of healthy soft tissue; no swelling, redness, or sinus tract for both groups including zinc oxide ozonated oil group and MTAP group during the follow-up periods 3,6,9,12 months follow up evaluate radiographic effect of both materials on: Continuity of lamina Dura, Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency., No newly formed radiographic lesion, Absence of pathological root resorption, and Evidence of bone regeneration utilizing gray value
primary outcome
Time frame: 3,6,9,12 months follow up
evaluate radiograhic effect of both materials on : * Continuity of lamina Dura. * Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency. * No newly formed radiographic lesion. * Absence of pathological root resorption * Evidence of bone regeneration utilizatig gray value
1 secondary outcome
secondary out come
Time frame: 12 months follow up
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 3 Mar 2025.
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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.
Shaimaa Sh El-Desokey, Professor principal investigator
Faculty of dentistry Tanta university , tanta
Fatma el hendawy, Professor study director
Faculty of dentistry Tanta university , Tanta
Nancy metwally, doctor study director
Faculty of dentistry Tanta university , Tanta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lesion sterlization and tissue repair, Zinc Oxide Ozonated Oil and Modified Triple Antibiotic Paste in people with Pulpitis - Irreversible and Ozone, run by Tanta University at 2 sites 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 0 inclusion and 6 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 nouran esmail shalaby, master (+20 01018710314 ext. 04836440064, PG_167682@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary out come (time frame: 3,6,9,12 months). The study lists 2 primary outcomes in all. 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 3 Mar 2025.