Clinical trial NCT04206826: Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
Official title: Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sicca Syndrome
Xerostomia
Keywords: natural film
prebiotics
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient will apply the two films (PreDelfi and control according to randomization) at the level of the gingival mucosa next to the maxillary vestibule for 30 days
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Tolerance evaluation
timeFrame: day 90
Secondary outcomes:
measure: Oral comfort
timeFrame: day 90
measure: Subjective evaluation of dry mouth
timeFrame: day 90
measure: Clinical assessment of the mucous
timeFrame: day 90
measure: Evaluation of salivary flow
timeFrame: day 90
measure: Evaluation of the salivary microbiota
timeFrame: day 90
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References: