Toothache relief: could a common painkiller beat standard root canal medicine?
NCT ID NCT07237620
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two medications placed inside the tooth after a failed root canal: standard calcium hydroxide and the painkiller diclofenac sodium. Sixty patients with persistent infection around the tooth root will be randomly assigned to one of the two treatments. Healing will be measured by changes in bone patterns on X-rays taken before and 12 months after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- calcium hydroxide and diclofenac sodium
- What this could lead to
- If this works, it could show that diclofenac sodium is a better option than standard calcium hydroxide for healing bone around the tooth root after a failed root canal.
- What could go wrong
- This is a small, early-phase study with only 60 patients, so results may not apply to everyone. The main measure is a change in bone pattern on X-rays, not a direct symptom check, and the 12-month follow-up may not capture long-term outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The study is planned to include patients aged 18-60 years who are systemically healthy (ASA I-II), present with apical periodontitis after primary root canal treatment, and have single-rooted, root-filled mandibular teeth with a periapical index (PAI) score of ≥3. Endodontic treatment failure is to be evaluated based on clinical and radiographic examinations. The duration of the initial endodontic treatment is to be at least four years or longer and/or the teeth are to exhibit clinical symptoms and signs. Previous root canal fillings are to be assessed for obturation quality and classified as satisfactory if they meet the following criteria: no visible voids, good condensation, and termination within 1-2 mm of the radiographic apex. If one or more of these criteria are not fulfilled, the obturation is to be classified as poor quality. The presence of post-treatment apical periodontitis, poor obturation quality, and/or persistent or newly developed symptoms (such as spontaneous pain, tenderness to palpation or percussion) and/or sinus tract formation are to be considered as indications for retreatment. Exclusion Criteria: Patients with a history of psychiatric disorders, allergic reactions, or pregnancy, and those who have taken analgesics within seven days prior to treatment or antibiotics within the previous three months, are to be excluded from the study. Teeth presenting with a periodontal pocket depth greater than 4 mm, severe coronal destruction preventing rubber dam placement, vertical root fracture, internal or external resorption, ankylosis, overfilling, open apex, or that have undergone surgical or nonsurgical retreatment after primary therapy are to be excluded. Teeth with perforation or fractured instruments are also to be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Merve Sarı
RECRUITINGHatay, Antakya, 31060, Turkey (Türkiye)
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