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

NCT ID: NCT04206826

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2021-04-23

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.

Conditions

Sicca Syndrome; Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PREDELFI Film

Group Type: EXPERIMENTAL

PREDELFI

Intervention Type: 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 Film

Group Type: PLACEBO_COMPARATOR

CONTROL

Intervention Type: DEVICE

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

Interventions

PREDELFI

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

Intervention Type: DEVICE

CONTROL

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Brest

Brest, , France

Countries

France

References

Orliaguet M, Fong SB, Le Pottier L, Meuric V, Boisrame S, Bonnaure-Mallet M, Pers JO. Tolerance to intraoral biofilms and their effectiveness in improving mouth dryness and modifying oral microbiota in patients with primary Sjogren's syndrome: "Predelfi study". Front Microbiol. 2023 Feb 8;14:1071683. doi: 10.3389/fmicb.2023.1071683. eCollection 2023.

Reference Type: DERIVED

PMID: 37293235 (View on PubMed)

Other Identifiers

29BRC18.0037 (PREDELFI)

Identifier Type: -

Identifier Source: org_study_id