NCT03400969

Brief Summary

This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

October 29, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

December 14, 2017

Last Update Submit

October 26, 2018

Conditions

Xerostomia

Keywords

PalliativeMoisturisersDry mouthXerostomia

Outcome Measures

Primary Outcomes (1)

  • Subjective xerostomia

    Measured on a 5-point Likert-scale: Subjective feeling of dry mouth: 1. Not dry 2. Insignificantly dry 3. Fairly dry 4. Almost completely dry 5. Completely dry

    3 days

Secondary Outcomes (4)

  • Pain/discomfort

    3 days

  • Speech

    3 days

  • Diurnal variation

    3 days

  • Situational dry mouth

    3 days

Study Arms (3)

Glycerol 17 %

ACTIVE COMPARATOR

Oral moisturizer

Device: Glycerol 17%

Aequasyal (OGT)

ACTIVE COMPARATOR

Oral moisturizer

Device: Aequasyal (OGT)

Salient (new product)

ACTIVE COMPARATOR

Oral moisturizer

Device: Salient (new product)

Interventions

Glycerol 17%DEVICE

Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.

Glycerol 17 %
Aequasyal (OGT)DEVICE

Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist.

Aequasyal (OGT)
Salient (new product)DEVICE

Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist.

Salient (new product)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients have xerostomia (subjective feeling of dry mouth). 2
  • The patients are palliative and in institutionalized care.
  • Curative treatment of existing diseases has been completed.
  • WHOs functional status 3/Karnofsky functional status 30 - 40 % (only capable of limited self-care, tied to bed or chair more than 50% of wake time).
  • Participants are cognitively functioning, capable of and willing to consent, capable of giving responses to a limited questionnaire and are expected to remain at the care centre for a minimum of 3 days.

You may not qualify if:

  • Patients treated with radiotherapy in head and neck region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5099, Norway

RECRUITING

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Gunhild V Strand, DDS, PhD

    University of Bergen, Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siri F. Kvalheim, DDS

CONTACT

0047 55586488Siri.Kvalheim@uib.no

Stein-Atle Lie, PhD

CONTACT

0047 55586477Stein.Lie@uib.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A Block randomisation is made by a person, other than the one who applies the product. Neither the patient nor the person who records the product or the person who registers data knows which product is used for the intervention. The product is not labeled with name
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The different moisturizers will be compared in a double blind, cross-over design. Patient responses will be collected at baseline, immediately after exposure and after 2 hours.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2017

First Posted

January 17, 2018

Study Start

March 1, 2018

Primary Completion

December 15, 2018

Study Completion

March 15, 2019

Last Updated

October 29, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Anonymous data will be available by request after publication of effect article.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available after publication of article.

Locations

NO(1)