Chronic Apical PeriodontitisNCT07057336
Evaluation of Post-Operative Pain Following the Use of Nano-Calcium Hydroxide
A study testing Conventional Calcium Hydroxide (CH) and Nanocalcium Hydroxide (NCH) in people with Chronic Apical Periodontitis, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effect of different intracanal medicaments-conventional calcium hydroxide (CH) and nano-sized calcium hydroxide (NCH)-on the intensity of postoperative pain following root canal treatment in asymptomatic necrotic single-rooted teeth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Apical Periodontitis
- What is being tested?
- Conventional Calcium Hydroxide (CH) and Nanocalcium Hydroxide (NCH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2024to 20 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- Single-rooted permanent maxillary or mandibular teeth
- Asymptomatic teeth with necrotic pulps confirmed by negative response to cold test
- Presence of periapical radiolucency (PAI score 2-5)
- No sensitivity to percussion or palpation
- Patients who signed informed consent
Who cannot join
- Pregnancy or lactation
- Systemic diseases requiring antibiotic prophylaxis (e.g., infective endocarditis, immunosuppression)
- Use of antibiotics, corticosteroids, or analgesics within the past 7 days
- History of chemotherapy or radiotherapy
- Uncontrolled diabetes mellitus or hypertension
- Chronic renal failure, hematologic disorders
Show all 10Show fewer
- Teeth with root resorption, previous endodontic treatment, or multirooted anatomy
- Teeth with periodontal pockets >4 mm or mobility
- Inability to attend follow-up visits
- Patients with extensive coronal destruction rendering definitive restoration unfeasible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-Operative Pain Following the Use of Nano-Calcium Hydroxide as an Intracanal Medicament: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the effect of different intracanal medicaments-conventional calcium hydroxide (CH) and nano-sized calcium hydroxide (NCH)-on the intensity of postoperative pain following root canal treatment in asymptomatic necrotic single-rooted teeth.
The primary research question of this study is as follows:
Read more
Does the use of nano-sized calcium hydroxide, compared to conventional calcium hydroxide, result in significantly reduced postoperative pain after root canal treatment?
In both groups, standardized instrumentation will be performed using rotary NiTi files and 2.5% sodium hypochlorite irrigation. After cleaning and shaping, canals will be medicated with either CH or NCH, followed by temporary sealing.
- Conditions
- Chronic Apical Periodontitis
- Being tested
- Conventional Calcium Hydroxide (CH), Nanocalcium Hydroxide (NCH)
- Keywords
- Calcium Hydroxide, Nanocalcium Hydroxide, Postoperative pain, Chronic apical periodontitis, Intracanal medicament
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Calcium Hydroxide (CH)Drug
Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. The cavity was sealed temporarily with a sterile cotton pellet and glass ionomer cement. Conventional calcium hydroxide was retained for 7 days before final obturation.
Nanocalcium Hydroxide (NCH)Drug
Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. The cavity was sealed temporarily with a sterile cotton pellet and glass ionomer cement. Nanocalcium hydroxide was retained for 7 days before final obturation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Calcium Hydroxide (CH) | Experimental | Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. Canals were then dried using sterile paper points. Conventional calcium hydroxide (CH) paste was introduced into the canal using a Lentulo spiral. A sterile cotton pellet was placed in the pulp chamber, and the cavity was sealed with glass ionomer cement. Receives: Drug: Conventional Calcium Hydroxide (CH) |
| Nanocalcium Hydroxide (NCH) | Experimental | Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. Canals were then dried using sterile paper points. Nanocalcium hydroxide (NCH) paste was placed into the canal using a Lentulo spiral to ensure uniform distribution. The access cavity was temporarily restored with a sterile cotton pellet and glass ionomer cement. Receives: Drug: Nanocalcium Hydroxide (NCH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start14 May 2024
- Primary completion15 Dec 2024
- Study completion20 Dec 2025
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 Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Över Kılıç, Cukurova University
- Investigators
- Hamdi Oğuz Yoldaş, DDS PHD, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057336
- Sponsor's protocol ID
- 05.04.2024/143
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amir N, Mansoor E, Eeman N, Ahmed MN, Mansoor E, Mansoor E, Hussain K, Afreixo V, Mansoor A, Brochado Martins JF, Palma PJ. Jasminum-based Nano-reinforced Calcium Hydroxide Reduces Postoperative Pain in Symptomatic Apical Periodontitis: A Randomized Controlled Trial. J Endod. 2025 Aug;51(8):996-1005. doi: 10.1016/j.joen.2025.05.016. Epub 2025 Jun 2.
PubMed 40466913
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Operative Pain Following the Use of Nano-Calcium Hydroxide as an Intracanal Medicament: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07057336
- Acronym / sponsor ID
- 05.04.2024/143
- Conditions
- Chronic Apical Periodontitis
- Keywords
- Calcium Hydroxide, Nanocalcium Hydroxide, Postoperative pain, Chronic apical periodontitis, Intracanal medicament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 9 Jul 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 goal of this clinical trial is to evaluate the effect of different intracanal medicaments-conventional calcium hydroxide (CH) and nano-sized calcium hydroxide (NCH)-on the intensity of postoperative pain following root canal treatment in asymptomatic necrotic single-rooted teeth.
The primary research question of this study is as follows:
Does the use of nano-sized calcium hydroxide, compared to conventional calcium hydroxide, result in significantly reduced postoperative pain after root canal treatment?
In both groups, standardized instrumentation will be performed using rotary NiTi files and 2.5% sodium hypochlorite irrigation. After cleaning and shaping, canals will be medicated with either CH or NCH, followed by temporary sealing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Calcium Hydroxide (CH) | Experimental | Drug: Conventional Calcium Hydroxide (CH)Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. Canals were then dried using sterile paper points. Conventional calcium hydroxide (CH) paste was introduced into the canal using a Lentulo spiral. A sterile cotton pellet was placed in the pulp chamber, and the cavity was sealed with glass ionomer cement. |
| Nanocalcium Hydroxide (NCH) | Experimental | Drug: Nanocalcium Hydroxide (NCH)Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. Canals were then dried using sterile paper points. Nanocalcium hydroxide (NCH) paste was placed into the canal using a Lentulo spiral to ensure uniform distribution. The access cavity was temporarily restored with a sterile cotton pellet and glass ionomer cement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-65 years
- Single-rooted permanent maxillary or mandibular teeth
- Asymptomatic teeth with necrotic pulps confirmed by negative response to cold test
- Presence of periapical radiolucency (PAI score 2-5)
- No sensitivity to percussion or palpation
Key exclusion criteria (10 listed)
- Pregnancy or lactation
- Systemic diseases requiring antibiotic prophylaxis (e.g., infective endocarditis, immunosuppression)
- Use of antibiotics, corticosteroids, or analgesics within the past 7 days
- History of chemotherapy or radiotherapy
- Uncontrolled diabetes mellitus or hypertension
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 |
|---|---|---|
| Conventional Calcium Hydroxide (CH)Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. The cavity was sealed temporarily with a sterile cotton pellet and glass ionomer cement. Conventional calcium hydroxide was retained for 7 days before final obturation. | Drug | Conventional Calcium Hydroxide (CH) |
| Nanocalcium Hydroxide (NCH)Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. The cavity was sealed temporarily with a sterile cotton pellet and glass ionomer cement. Nanocalcium hydroxide was retained for 7 days before final obturation. | Drug | Nanocalcium Hydroxide (NCH) |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: up to 72 hours
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
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 31 Aug 2026.
- Background: PubMed 40466913Amir N, Mansoor E, Eeman N, Ahmed MN, Mansoor E, Mansoor E, Hussain K, Afreixo V, Mansoor A, Brochado Martins JF, Palma PJ. Jasminum-based Nano-reinforced Calcium Hydroxide Reduces Postoperative Pain in Symptomatic Apical Periodontitis: A Randomized Controlled Trial. J Endod. 2025 Aug;51(8):996-1005. doi: 10.1016/j.joen.2025.05.016. Epub 2025 Jun 2.
- Individual participant dataSharing planned: No
Related trials for Chronic Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Active, not recruiting
Effects of Irrigation Activation Methods on Periapical Healing in Chronic Apical Periodontitis
Chronic Apical Periodontitis
Active, not recruiting
Rotary Versus Manual Degranulation in Alveolar Ridge Preservation
Chronic Periapical Periodontitis, Alveolar Ridge Preservation
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.
Hamdi Oğuz Yoldaş, DDS PHD principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Calcium Hydroxide (CH) and Nanocalcium Hydroxide (NCH) in people with Chronic Apical Periodontitis, run by Cukurova 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 6 inclusion and 10 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 31 Aug 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?
Visual Analogue Scale (VAS) (time frame: up to 72 hours). 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 NCT07057336, 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 31 Aug 2026.