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
About this trial
This is an interventional treatment trial for Sicca Syndrome focused on measuring natural film, prebiotics
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)
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
NCT ID
NCT04206826
First Posted
December 10, 2019
Last Updated
May 12, 2021
Sponsor
University Hospital, Brest
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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