Apical PeriodontitisNCT07722416
Postoperative Pain After OCT or EDTA Irrigation in Regenerative Endodontic Treatment
A study testing Regenerative Endodontic Treatment Using Different Irrigation Solutions in people with Apical Periodontitis and Endodontic Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial evaluated the effect of two different irrigation solutions on postoperative pain following regenerative endodontic treatment of necrotic immature permanent teeth with apical periodontitis. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Endodontic Disease
- What is being tested?
- Regenerative Endodontic Treatment Using Different Irrigation Solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 12 Jul 2026
- 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemically healthy status classified as American Society of Anesthesiologists class I;
- An immature permanent tooth with pulp necrosis and apical periodontitis;
- Cvek stage 2 or 3 root development;
- Preoperative pain below 40 on a 0-100 numerical rating scale (NRS);
- A baseline Periapical Index (PAI) score between 2 and 4;
- A tooth considered restorable and suitable for RET; and
- Willingness of the participant and legal representative to comply with postoperative assessment and follow-up requirements.
Who cannot join
- systemic disease
- bruxism or another parafunctional habit
- had used analgesics within 12 hours before treatment
- severe root canal curvature
- vertical root fracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes Üniversitesi Diş Hekimliği Fakültesi
Kayseri, Kayseri, 38039
About this study
Official title: Effect of Different Irrigation Protocols on Postoperative Pain Following Regenerative Endodontic Treatment: A Randomized Clinical Trial
This randomized clinical trial evaluated the effect of two different irrigation solutions on postoperative pain following regenerative endodontic treatment of necrotic immature permanent teeth with apical periodontitis. Participants were randomly allocated to receive either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) during regenerative endodontic treatment.
A total of 40 patients aged 9 to 16 years were included and allocated to the two intervention groups in a 1:1 ratio. Postoperative pain was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from the second through the seventh postoperative day. Analgesic use and the occurrence of flare-up were also evaluated.
Read the detailed description
Necrotic immature permanent teeth with apical periodontitis present a clinical challenge because incomplete root development is associated with thin dentinal walls, an open apex, and an increased risk of root fracture. Regenerative endodontic treatment is a biologically based procedure that aims to control intracanal infection, promote healing of the periapical tissues, and allow continued root development.
Successful regenerative endodontic treatment requires effective root canal disinfection while preserving an environment that supports the survival and activity of stem cells from the apical papilla. Ethylenediaminetetraacetic acid (EDTA) is commonly used in regenerative procedures because of its chelating properties, its ability to modify the dentin surface, and its potential to promote the release of dentin-derived bioactive molecules. Octenidine dihydrochloride (OCT) is a broad-spectrum antiseptic that has demonstrated antimicrobial activity and potentially favorable biological effects on dental-derived stem cells. However, clinical evidence regarding the use of OCT during regenerative endodontic treatment remains limited.
This prospective, participant-blinded, parallel-group randomized clinical trial included 40 systemically healthy patients aged 9 to 16 years who had a necrotic immature permanent tooth with apical periodontitis. Eligible teeth had Cvek stage 2 or 3 root development and a baseline Periapical Index score between 2 and 4. Each participant contributed one tooth to the study.
Participants were randomly assigned in a 1:1 ratio to one of two irrigation groups:
- The OCT group received 0.1% octenidine dihydrochloride.
- The EDTA group received 17% ethylenediaminetetraacetic acid.
Regenerative endodontic treatment was performed in two visits. During the first visit, the root canal was initially irrigated with 1.5% sodium hypochlorite. The allocated OCT or EDTA solution was then applied and ultrasonically activated. Calcium hydroxide was placed as an intracanal medicament, and the access cavity was temporarily sealed.
The second visit was performed approximately two weeks later. After removal of the intracanal medicament, the root canal was irrigated again according to the allocated protocol, and the irrigant was ultrasonically activated. Apical bleeding was induced to create an intracanal blood clot. Biodentine was placed over the blood clot as a coronal barrier, and the tooth was permanently restored with resin composite.
The primary outcome was postoperative pain intensity, which was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from day 2 through day 7 after the second treatment visit. Secondary outcomes included analgesic consumption and the occurrence of flare-up, defined as severe postoperative pain and/or swelling requiring an unscheduled clinical visit.
- Conditions
- Apical Periodontitis, Endodontic Disease
- Being tested
- Regenerative Endodontic Treatment Using Different Irrigation Solutions
- Keywords
- apical periodontitis, immature permanent teeth, octenidine dihydrochloride, postoperative pain, regenerative endodontic treatment
- Medical subject headings
- Periapical Periodontitis, Dental Pulp Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontic Treatment Using Different Irrigation SolutionsOther
Regenerative endodontic treatment was performed using either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) as the allocated irrigation solution. In both groups, 20 mL of the assigned irrigant was applied for 5 minutes during each treatment visit and ultrasonically activated for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| 17% Ethylenediaminetetraacetic Acid (EDTA) | Active comparator | Participants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 17% ethylenediaminetetraacetic acid (EDTA) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups. Receives: Other: Regenerative Endodontic Treatment Using Different Irrigation Solutions |
| 0.1% Octenidine Dihydrochloride (OCT) | Active comparator | Participants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 0.1% octenidine dihydrochloride (OCT) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups. Receives: Other: Regenerative Endodontic Treatment Using Different Irrigation Solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured Using a Numerical Rating Scale
Postoperative pain intensity was self-recorded by participants using a numerical rating scale ranging from 0 to 100, where 0 indicated no pain and 100 indicated the worst pain imaginable. Higher scores indicated greater postoperative pain intensity. Pain scores were recorded after the second regenerative endodontic treatment visit.
Measured: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Secondary outcomes (1)
Postoperative Analgesic Consumption
Participants were instructed to use paracetamol only when postoperative pain persisted. A dose of 250 to 500 mg was recommended according to the participant's age and body weight. The number of paracetamol tablets taken at each assessment time was recorded as 0, 1, or 2. Higher values indicated greater analgesic consumption.
Measured: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start10 Apr 2026
- Primary completion8 Jun 2026
- Study completion12 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel intervention arms. One arm received 0.1% octenidine dihydrochloride, and the other arm received 17% ethylenediaminetetraacetic acid during regenerative endodontic treatment. Each participant remained in the assigned intervention arm throughout the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busranur Yavuz, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722416
- Sponsor's protocol ID
- 2026/192
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Irrigation Protocols on Postoperative Pain Following Regenerative Endodontic Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07722416
- Acronym / sponsor ID
- 2026/192
- Conditions
- Apical Periodontitis, Endodontic Disease
- Keywords
- apical periodontitis, immature permanent teeth, octenidine dihydrochloride, postoperative pain, regenerative endodontic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 12 Jul 2026 (actual)
- First posted
- 23 Jul 2026 (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 randomized clinical trial evaluated the effect of two different irrigation solutions on postoperative pain following regenerative endodontic treatment of necrotic immature permanent teeth with apical periodontitis. Participants were randomly allocated to receive either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) during regenerative endodontic treatment.
A total of 40 patients aged 9 to 16 years were included and allocated to the two intervention groups in a 1:1 ratio. Postoperative pain was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from the second through the seventh postoperative day. Analgesic use and the occurrence of flare-up were also evaluated.
Detailed description
Necrotic immature permanent teeth with apical periodontitis present a clinical challenge because incomplete root development is associated with thin dentinal walls, an open apex, and an increased risk of root fracture. Regenerative endodontic treatment is a biologically based procedure that aims to control intracanal infection, promote healing of the periapical tissues, and allow continued root development.
Successful regenerative endodontic treatment requires effective root canal disinfection while preserving an environment that supports the survival and activity of stem cells from the apical papilla. Ethylenediaminetetraacetic acid (EDTA) is commonly used in regenerative procedures because of its chelating properties, its ability to modify the dentin surface, and its potential to promote the release of dentin-derived bioactive molecules. Octenidine dihydrochloride (OCT) is a broad-spectrum antiseptic that has demonstrated antimicrobial activity and potentially favorable biological effects on dental-derived stem cells. However, clinical evidence regarding the use of OCT during regenerative endodontic treatment remains limited.
This prospective, participant-blinded, parallel-group randomized clinical trial included 40 systemically healthy patients aged 9 to 16 years who had a necrotic immature permanent tooth with apical periodontitis. Eligible teeth had Cvek stage 2 or 3 root development and a baseline Periapical Index score between 2 and 4. Each participant contributed one tooth to the study.
Participants were randomly assigned in a 1:1 ratio to one of two irrigation groups:
- The OCT group received 0.1% octenidine dihydrochloride.
- The EDTA group received 17% ethylenediaminetetraacetic acid.
Regenerative endodontic treatment was performed in two visits. During the first visit, the root canal was initially irrigated with 1.5% sodium hypochlorite. The allocated OCT or EDTA solution was then applied and ultrasonically activated. Calcium hydroxide was placed as an intracanal medicament, and the access cavity was temporarily sealed.
The second visit was performed approximately two weeks later. After removal of the intracanal medicament, the root canal was irrigated again according to the allocated protocol, and the irrigant was ultrasonically activated. Apical bleeding was induced to create an intracanal blood clot. Biodentine was placed over the blood clot as a coronal barrier, and the tooth was permanently restored with resin composite.
The primary outcome was postoperative pain intensity, which was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from day 2 through day 7 after the second treatment visit. Secondary outcomes included analgesic consumption and the occurrence of flare-up, defined as severe postoperative pain and/or swelling requiring an unscheduled clinical visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel intervention arms. One arm received 0.1% octenidine dihydrochloride, and the other arm received 17% ethylenediaminetetraacetic acid during regenerative endodontic treatment. Each participant remained in the assigned intervention arm throughout the study.
| Arm | Type | Receives |
|---|---|---|
| 17% Ethylenediaminetetraacetic Acid (EDTA) | Active comparator | Other: Regenerative Endodontic Treatment Using Different Irrigation SolutionsParticipants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 17% ethylenediaminetetraacetic acid (EDTA) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups. |
| 0.1% Octenidine Dihydrochloride (OCT) | Active comparator | Other: Regenerative Endodontic Treatment Using Different Irrigation SolutionsParticipants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 0.1% octenidine dihydrochloride (OCT) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Systemically healthy status classified as American Society of Anesthesiologists class I;
- An immature permanent tooth with pulp necrosis and apical periodontitis;
- Cvek stage 2 or 3 root development;
- Preoperative pain below 40 on a 0-100 numerical rating scale (NRS);
- A baseline Periapical Index (PAI) score between 2 and 4;
Key exclusion criteria (5 listed)
- systemic disease
- bruxism or another parafunctional habit
- had used analgesics within 12 hours before treatment
- severe root canal curvature
- vertical root fracture
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 |
|---|---|---|
| Regenerative Endodontic Treatment Using Different Irrigation SolutionsRegenerative endodontic treatment was performed using either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) as the allocated irrigation solution. In both groups, 20 mL of the assigned irrigant was applied for 5 minutes during each treatment visit and ultrasonically activated for 1 minute. | Other | 0.1% Octenidine Dihydrochloride (OCT), 17% Ethylenediaminetetraacetic Acid (EDTA) |
Primary outcome
Postoperative Pain Intensity Measured Using a Numerical Rating Scale
Time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Postoperative pain intensity was self-recorded by participants using a numerical rating scale ranging from 0 to 100, where 0 indicated no pain and 100 indicated the worst pain imaginable. Higher scores indicated greater postoperative pain intensity. Pain scores were recorded after the second regenerative endodontic treatment visit.
1 secondary outcome
Postoperative Analgesic Consumption
Time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
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 23 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative Endodontic Treatment Using Different Irrigation Solutions in people with Apical Periodontitis and 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 7 inclusion and 5 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 23 Oct 2026. 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.
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?
Postoperative Pain Intensity Measured Using a Numerical Rating Scale (time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit). 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 23 Oct 2026.