European real-Life use of Eludril eXtra among 4 countries (ELEX4)

23/04/2026
23/04/2026
EU PAS number:
EUPAS1000000986
Study
Finalised
Study identification

EU PAS number

EUPAS1000000986

Study ID

1000000986

Official title and acronym

European real-Life use of Eludril eXtra among 4 countries (ELEX4)

DARWIN EU® study

No

Study countries

Bulgaria
Greece
Poland
Portugal

Study description

Chlorhexidine 0.2% mouthrinse (Eludril Extra) is widely used in dentistry as an adjunct to mechanical plaque control for the prevention and management of gingivitis, periodontitis, peri-implant mucositis, and other oral conditions. Oral health is strongly influenced by systemic diseases such as diabetes and cancer, as well as pregnancy and lifestyle factors, and is associated with a significant impact on quality of life.
This study aimed to evaluate the impact of CHX 0.2% in routine clinical practice on oral health-related quality of life (OHRQoL), as well as treatment use, compliance, and patient and dentist satisfaction. Particular attention was given to special-interest populations, including pregnant women, diabetic patients, oncological patients, and patients with peri-implant mucositis.
This was a prospective, longitudinal, observational cohort study conducted in four European countries (Bulgaria, Greece, Poland, and Portugal). Adult patients prescribed CHX 0.2% mouthrinse as part of routine dental care were included after the prescribing decision made by the dentist. Treatment initiation and follow-up were fully driven by routine clinical practice, without any intervention from the study protocol.
Data were collected at baseline and at a single follow-up visit between 10-20 days. Collected variables included socio-demographic characteristics, medical history, oral health status, clinical parameters, treatment patterns, compliance, and satisfaction. Oral health status was assessed using clinical indicators such as bleeding on probing, gingival inflammation, and plaque index (Silness-Löe Index). OHRQoL was measured using the validated Oral Health Impact Profile-5 (OHIP-5).
The primary endpoint was the change in OHRQoL (OHIP-5 score) between baseline and follow-up. Secondary endpoints included description of real-world use of CHX 0.2%, patient compliance, and patient and dentist satisfaction with treatment. A total of 408 patients were included in the analysis.

Study status

Finalised
Research institutions and networks

Institutions

Pierre Fabre Oral Care

Contact details

Jean-Noel Vergnes

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
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Data analysis start date

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Date of final study report

Planned:
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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pierre Fabre Oral Care
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable