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

Primary Purpose

Sicca Syndrome, Xerostomia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PREDELFI
CONTROL
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sicca Syndrome focused on measuring natural film, prebiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHRU Brest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PREDELFI Film

CONTROL Film

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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,...)
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.
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)

Full Information

First Posted
December 10, 2019
Last Updated
May 12, 2021
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04206826
Brief Title
Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
Acronym
PREDELFI
Official Title
Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sicca Syndrome, Xerostomia
Keywords
natural film, prebiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PREDELFI Film
Arm Type
Experimental
Arm Title
CONTROL Film
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
PREDELFI
Intervention Description
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
Intervention Name(s)
CONTROL
Intervention Description
It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.
Primary Outcome Measure Information:
Title
Tolerance evaluation
Description
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
Time Frame
day 90
Secondary Outcome Measure Information:
Title
Oral comfort
Description
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)
Time Frame
day 90
Title
Subjective evaluation of dry mouth
Description
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
Time Frame
day 90
Title
Clinical assessment of the mucous
Description
Objective clinical assessment of the general condition of the mucous membranes (redness, dryness, degree of inflammation of periodontal tissues, mucous membranes,...)
Time Frame
day 90
Title
Evaluation of salivary flow
Description
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.
Time Frame
day 90
Title
Evaluation of the salivary microbiota
Description
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)
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning five years and ending fifteen years following the final study report completion
IPD Sharing 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.

Learn more about this trial

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

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