Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Xerostomia

Sicca Syndrome

Treatments

Device: PREDELFI

Device: CONTROL

Study type

Interventional

Funder types

Other

Identifiers

NCT04206826

29BRC18.0037 (PREDELFI)

Details and patient eligibility

About

Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. It handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. This dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. Today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. This study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.

Full description

The purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film.

The primary endpoint is the assessment of tolerability assessed using a visual analogue scale (VAS) from 0 to 100 at the end of the 1-month period of both treatment periods (D30 and D90). In this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed.

Each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men or women aged 18 or over
Complaining of xerostomia and validated by a standardized question
With hyposialia diagnosed by the measurement of stimulated salivary flow (DSS) and unstimulated (DNS)
Patient having signed a consent
Registered with Social Security

Exclusion criteria

The patient having known sensitivity to any of the products or components of the biofilms (milk protein, soy derivatives, sodium alginate, vegetable glycerin, caramel and beta carotene)
Allergic to birch and / or peanut
Having an ethyl intoxication (> 2 glasses of wine / day), smoking (> 10 cigarettes / day)
Unable to complete self-assessment questionnaires or to follow study protocol procedures (unable to read and / or write).
Participant in another clinical study at the time of inclusion or having participated in the 30 days preceding recruitment in this study
Having a life-threatening condition for the duration of the study
Treated with sialogogues (pilocarpine hydrochloride) within 30 days prior to inclusion
Using salivary substitutes
Protected persons within the law (articles L1121-5 to L1121-8)