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

NCT04206826 | Completed

• 1 other identifier: 29BRC18.0037 (PREDELFI)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sicca Syndrome; Xerostomia

Keywords

natural film; prebiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Oral comfort

  day 90

• Subjective evaluation of dry mouth

  day 90

• Clinical assessment of the mucous

  day 90

• Evaluation of salivary flow

  day 90

• Evaluation of the salivary microbiota

  day 90

Study Arms (2)

PREDELFI Film

EXPERIMENTAL

Device: PREDELFI

CONTROL Film

PLACEBO COMPARATOR

Device: CONTROL

Interventions

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

PREDELFI Film

CONTROL DEVICE

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

CONTROL Film

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Having a life-threatening condition for the duration of the study
• Using salivary substitutes
• Protected persons within the law (articles L1121-5 to L1121-8)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, 29609, France

Location

Related Publications (1)

• 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.

  PMID: 37293235 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 20, 2019
• Study Start: June 25, 2020
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: February 5, 2025

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)