Thymol Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial evaluated the clinical utility of thymol in oral health applications, specifically examining the efficacy of a chlorhexidine and thymol varnish on abutment teeth in patients wearing partial dentures for conditions including periodontal disease and dental caries. Conducted as a Phase 4 study with support from academic and industry sponsors, the trial's recruitment status is reported as withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02202304	Withdrawn	Periodontal Disease\|Caries	Rosa Moreno Lopez\|Ivoclar Vivadent AG\|University of Aberdeen	2017-09-10	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Thymol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thymol interacts with bacterial lipid membranes and inhibits pro-inflammatory signaling cascades, thereby disrupting membrane permeability and suppressing downstream inflammatory mediator release. This cellular inhibition reduces bacterial viability and localized tissue inflammation, providing a therapeutic rationale for its clinical investigation in periodontal disease and dental caries.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).