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
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
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- 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.
- 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