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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sicca Syndrome, Xerostomia

Intervention / Treatment
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* Device: PREDELFI
* Device: CONTROL


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREDELFI Film<br> | Device: PREDELFI<br>* It's a natural film which contains a concentrated alpha-GOS (alpha-galacto-oligosaccharide) soy extract, a milk protein concentrate containing caseins and whey proteins and vegetable glycerin<br>|
| Placebo Comparator: CONTROL Film<br> | Device: CONTROL<br>* It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance evaluation | The primary endpoint is a composite endpoint of tolerance evaluation defined by: the patient (EVA from 0 to 100), the investigator (degree of redness and inflammation of the mucous membranes opposite the site of the device, reporting adverse events related to the device | day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral comfort | Self-evaluation of the patient's oral dryness (oral comfort) using a 100mm visual analogue scale (measurement of the absolute variation at the beginning and end of each treatment period) | day 90 | 
| Subjective evaluation of dry mouth | Subjective evaluation of the absolute variation of the specific signs and symptoms of dry mouth (difficulty speaking, chewing swallowing, taste alteration, burning sensations) using 100 mm analogue visual scales | day 90 | 
| Clinical assessment of the mucous | Objective clinical assessment of the general condition of the mucous membranes (redness, dryness, degree of inflammation of periodontal tissues, mucous membranes,...) | day 90 | 
| Evaluation of salivary flow | Objective evaluation of the absolute variation of the stimulated and unstimulated salivary flow rates according to the dosage forms used and the variation of the oral pH using specific strips. | day 90 | 
| Evaluation of the salivary microbiota | Evaluation by molecular sequencing of the salivary microbiota to study the impact of the film on the modification of the salivary microbiota (quantification of the different species by NGS) | day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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natural film, prebiotics