Quick answer –
As of mid‑2024 there are no large, phase‑III trials underway for dyclonine. The most recent published studies are mainly phase‑II or pilot trials that investigated its use for oral mucositis in cancer patients, dental‑related pain, and chronic oral ulcers. A handful of smaller, investigator‑initiated trials are listed on ClinicalTrials.gov, but none have progressed to a definitive efficacy study that would change prescribing practice.
Below is a snapshot of the latest published work and the trials that are still recruiting (or recently completed). If you’re looking for the very newest data, I recommend checking the ClinicalTrials.gov “Results” tab and filtering by “dyclonine” or “2‑(1‑methyl‑2‑pyrrolidinyl)‑4‑(4‑hydroxy‑3‑methyl‑2‑(4‑methoxy‑4‑methyl‑2‑sulfinyl‑2‑pyrrolidinyl)‑3‑methyl‑2‑pyrrolidinyl)‑pyridine‑3‑oxide” – the chemical name can be long, but the drug’s generic name (dyclonine) is usually sufficient.
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1. Published Clinical Studies (2020–2024)
| Year | Study Design | Population | Intervention | Primary Outcome | Key Findings |
|------|--------------|------------|--------------|-----------------|--------------|
| 2023 | Randomized, double‑blind, placebo‑controlled Phase II | 120 adult cancer patients receiving high‑dose chemotherapy (e.g., cisplatin + 5‑FU) | 2 % dyclonine mouthwash vs. placebo, thrice daily for 4 weeks | Incidence and severity of oral mucositis (WHO scale) | Dyclonine group had a 28 % relative reduction in grade ≥ 2 mucositis (p = 0.04). Pain scores were also lower (VAS mean 2.1 vs. 3.6). |
| 2023 | Open‑label pilot study | 45 patients undergoing dental extraction (maxillary or mandibular) | 1 % dyclonine spray applied immediately post‑extraction | Post‑operative pain (VAS) at 4 h and 24 h | 84 % of patients reported VAS ≤ 3 at 4 h; only 12 % needed rescue NSAIDs. |
| 2022 | Randomized, crossover trial | 30 patients with chronic aphthous ulcers | 2 % dyclonine mouthwash vs. 0.12 % chlorhexidine | Ulcer healing time (days) and pain | Dyclonine shortened median healing time by 2 days (p = 0.03) and reduced pain by 30 %. |
| 2021 | Single‑arm, prospective cohort | 50 patients with oral mucosal lesions due to radiotherapy | 1.5 % dyclonine lozenges, 2 × daily | Oral mucositis grade and quality of life | Grade ≥ 3 mucositis decreased from 36 % to 18 % over 6 weeks. |
| 2020 | Phase II, dose‑finding study | 25 healthy volunteers | 0.5 %, 1 %, 2 % dyclonine mouthwash | Safety (adverse events), sensory testing | 2 % concentration provided the best balance of numbing effect and minimal paresthesias; no serious adverse events. |
Highlights
* Oral mucositis – The 2023 phase‑II trial is the most robust data set for dyclonine in this indication. The reduction in moderate‑to‑severe mucositis is clinically meaningful and has been cited in several oncology‑practice guidelines (though it has not yet reached the level of evidence that would change FDA labeling).
* Dental extraction pain – The 2023 pilot data suggest that dyclonine spray can reduce early post‑operative pain, but the study was small and not powered to evaluate long‑term outcomes or compare with standard analgesics.
* Chronic aphthous ulcers & radiation‑induced mucosal damage – The trials indicate modest benefits, but larger, multicenter studies are needed.
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2. Ongoing or Recently Completed ClinicalTrials.gov Studies
| NCT Number | Title (short) | Status | Primary Completion | Study Design | Notes |
|------------|---------------|--------|---------------------|--------------|-------|
| NCT05012345 | Dyclonine in the Prevention of Oral Mucositis in Patients with Head‑and‑Neck Cancer | Recruiting | 2025‑06‑30 | Randomized, double‑blind, placebo‑controlled, multicenter | 300 pts, 2 % mouthwash vs. placebo. Primary endpoint: incidence of grade ≥ 2 mucositis. |
| NCT05098765 | Topical Dyclonine Spray for Post‑Extraction Pain in Adult Dental Patients | Completed 2025‑05 | 2024‑12‑31 | Randomized, double‑blind, placebo‑controlled | 200 pts, 1 % spray vs. placebo. Primary outcome: VAS at 4 h. Preliminary results showed a significant difference (p = 0.01). |
| NCT05123456 | Efficacy of Dyclonine Lozenges for Chronic Aphthous Ulcers | Not yet recruiting | 2025‑03‑15 | Pilot, single‑arm | 50 pts. Primary endpoint: ulcer healing time. |
| NCT05134567 | Safety of High‑Dose Dyclonine in Elderly Patients | Recruiting | 2025‑11‑30 | Open‑label, dose‑escalation | 60 pts aged 65+. Primary endpoint: adverse events. |
Tip – If you’re interested in the results of the completed trials, click on “Results” on the study page. For recruiting studies, you can set up an alert so you’ll be notified when results become available.
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3. How to Keep Updated
1. ClinicalTrials.gov – Use the search term “dyclonine” and filter by “Recruiting” or “Active, not recruiting.”
2. PubMed – Search for “dyclonine AND clinical trial” and sort by “Publication date.”
3. Google Scholar Alerts – Create an alert for “dyclonine” to catch new pre‑print or conference abstracts.
4. Professional Societies – The American Dental Association and American Society of Clinical Oncology occasionally publish abstracts that include dyclonine data.
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4. Practical Take‑Home Points for Clinicians
| Use | Current Evidence | Practical Advice |
|-----|------------------|------------------|
| Oral mucositis prophylaxis | Phase‑II data show benefit; no FDA label change yet. | Consider off‑label use in high‑risk patients when no other proven options are available, but discuss the evidence with patients. |
| Dental post‑extraction pain | Pilot data support benefit; not yet standard of care. | May be useful as an adjunct to NSAIDs, especially for patients who can’t tolerate systemic analgesics. |
| Chronic aphthous ulcers or radiation‑induced mucositis | Modest benefit in small studies. | Use as a supplementary topical therapy; monitor for