Endodontic DiseasePhase 4NCT06386991
Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing
A Phase 4 study testing Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments in people with Endodontic Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Phase 4
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teeth with apical periodontitis
- Teeth for which prosthetic restoration is not planned
- Patients between the ages of 8-15 who do not have any significant health problems
- Patients who are not accompanied by periodontal problems and have good oral hygiene
- Exclusion Criteria:• People with systemic disease and allergic reactions
- Severely damaged teeth
- If the tooth has previously undergone root canal treatment.
- Use of antibiotics, anti-inflammatory and painkillers in the last two weeks
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes Üniversitesi Diş Hekimliği Fakültesi
Kayseri, 38039
ERASLAN AKYÜZ, 4447138 ext. 0352, ipekemamak@hotmail.com
ÜSTÜN, 4447138 ext. 0352, yustun@erciyes.edu.tr
About this study
Official title: Evaluation of the Effects of Different Irrigation Solutions Used in Regenerative Endodontic Treatment of Lower Molars With Open Necrotic Apexes on Postoperative Pain and Lesion Healing
In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year.
Read the detailed description
Root canal treatment is a treatment method applied to milk and permanent teeth. The inflamed and necrotic pulp where the root canal is located is cleaned, debrided chemo-mechanically, and finally filled hermetically with a biocompatible material. Necrotic immature teeth lose their restorative and defensive abilities. Since the root canal walls of these teeth are thin and weak, regenerative endodontic procedures are applied more frequently in the treatment of immature teeth to ensure root development and to restore the vitality of the pulp tissue. In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year.
- Conditions
- Endodontic Disease
- Being tested
- Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments
- 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.
Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatmentsOther
Regenerative endodontic treatment using different irrigation solutions
| Study group | Role | What they receive |
|---|---|---|
| Ethylenediamine tetraacetic acid (EDTA) | Active comparator | Regenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and Ethylenediamine tetraacetic acid (EDTA)will be used when disinfecting root canals. (GROUP 1) Receives: Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments |
| CITRIC ACID (MONO/ANH) | Active comparator | Regenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and CITRIC ACID (MONO/ANH) be used when disinfecting root canals. (GROUP 2) Receives: Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments |
| ETİDRONİC ACID (HEBP) | Active comparator | Regenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and ETİDRONİC ACID (HEBP) be used when disinfecting root canals. (GROUP 3) Receives: Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining and recording pain levels on the pain scale between treatment sessions
Evaluations close to 100 on the postoperative pain scale indicate that the severity of pain increases. Evaluations close to 0 indicate that the severity of pain has decreased.
Measured: 2 weeks
Secondary outcomes (1)
In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography.
Evaluations close to 100 on the scale following lesion healing indicate that the lesion size has increased. Evaluations close to 0 indicate that the lesion size has decreased.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ipek Eraslan Akyuz, TC Erciyes University
- Investigators
- ERASLAN AKYÜZ, Principal investigator, BAŞ ARAŞTIRMACIÜSTÜN, Study director, YÜRÜTÜCÜEMİNSOY AVCI, Study chair, YARDIMCI ARAŞTIRMACISOLAK KOLÇAKOĞLU, Study chair, YARDIMCI ARAŞTIRMACIKIZILCI, Study chair, YARDIMCI ARAŞTIRMACI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386991
- Sponsor's protocol ID
- 2024/206
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akyuz IE, Eminsoy Avci AT, Ustun Y, Kolcakoglu KS, Kizilci E. Evaluation of the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic molar teeth with open apex on postoperative pain- randomized clinical trial. Clin Oral Investig. 2025 Jan 16;29(1):66. doi: 10.1007/s00784-025-06153-3.
PubMed 39815035
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Irrigation Solutions Used in Regenerative Endodontic Treatment of Lower Molars With Open Necrotic Apexes on Postoperative Pain and Lesion Healing
- ClinicalTrials.gov ID
- NCT06386991
- Acronym / sponsor ID
- 2024/206
- Conditions
- Endodontic Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 26 Apr 2024 (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 this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year.
Detailed description
Root canal treatment is a treatment method applied to milk and permanent teeth. The inflamed and necrotic pulp where the root canal is located is cleaned, debrided chemo-mechanically, and finally filled hermetically with a biocompatible material. Necrotic immature teeth lose their restorative and defensive abilities. Since the root canal walls of these teeth are thin and weak, regenerative endodontic procedures are applied more frequently in the treatment of immature teeth to ensure root development and to restore the vitality of the pulp tissue. In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ethylenediamine tetraacetic acid (EDTA) | Active comparator | Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatmentsRegenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and Ethylenediamine tetraacetic acid (EDTA)will be used when disinfecting root canals. (GROUP 1) |
| CITRIC ACID (MONO/ANH) | Active comparator | Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatmentsRegenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and CITRIC ACID (MONO/ANH) be used when disinfecting root canals. (GROUP 2) |
| ETİDRONİC ACID (HEBP) | Active comparator | Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatmentsRegenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and ETİDRONİC ACID (HEBP) be used when disinfecting root canals. (GROUP 3) |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Teeth with apical periodontitis
- Teeth for which prosthetic restoration is not planned
- Patients between the ages of 8-15 who do not have any significant health problems
- Patients who are not accompanied by periodontal problems and have good oral hygiene
- Exclusion Criteria:• People with systemic disease and allergic reactions
Key exclusion criteria (0 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 |
|---|---|---|
| Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatmentsRegenerative endodontic treatment using different irrigation solutions | Other | CITRIC ACID (MONO/ANH), ETİDRONİC ACID (HEBP), Ethylenediamine tetraacetic acid (EDTA) |
Primary outcome
Determining and recording pain levels on the pain scale between treatment sessions
Time frame: 2 weeks
Evaluations close to 100 on the postoperative pain scale indicate that the severity of pain increases. Evaluations close to 0 indicate that the severity of pain has decreased.
1 secondary outcome
In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 39815035Akyuz IE, Eminsoy Avci AT, Ustun Y, Kolcakoglu KS, Kizilci E. Evaluation of the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic molar teeth with open apex on postoperative pain- randomized clinical trial. Clin Oral Investig. 2025 Jan 16;29(1):66. doi: 10.1007/s00784-025-06153-3.
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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.
ERASLAN AKYÜZ principal investigator
BAŞ ARAŞTIRMACI
ÜSTÜN study director
YÜRÜTÜCÜ
EMİNSOY AVCI study chair
YARDIMCI ARAŞTIRMACI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments in people with Endodontic Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 8 inclusion and 0 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 26 Apr 2024. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 ERASLAN AKYÜZ (4447138 ext. 0352, ipekemamak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining and recording pain levels on the pain scale between treatment sessions (time frame: 2 weeks). 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 NCT06386991, which also lists 1 linked publication.
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 26 Apr 2024.