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NCT Number: NCT04206826

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

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.

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Key information

Conditions

Sicca Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PREDELFI

Device

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

Control

Device

It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.

Primary outcomes

  1. Tolerance evaluation

    Time frame: day 90

    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

Secondary outcomes

  1. Oral comfort

    Time frame: day 90

    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)

  2. Subjective evaluation of dry mouth

    Time frame: day 90

    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

  3. Clinical assessment of the mucous

    Time frame: day 90

    Objective clinical assessment of the general condition of the mucous membranes (redness, dryness, degree of inflammation of periodontal tissues, mucous membranes,...)

  4. Evaluation of salivary flow

    Time frame: day 90

    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.

  5. Evaluation of the salivary microbiota

    Time frame: day 90

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PREDELFI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2019
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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