Randomized investigator-blinded crossover study of the efficacy of XyliMelts adhesive tablets for symptomatic relief of nocturnal dry mouth in patients with dry mouth after head and neck irradiation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030537

Enrollment

Registered

2022-10-18

Start date

2023-10-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K11.7 Z92.3

Interventions

Group 1: XyliMelts Adhesive Tablets (retarded xylitol (550 mg), gum arabic, cellulose gum, magnesium stearate, mild natural mint (not included in "Nature" flavor), sodium bicarbonate, calcium carbonat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Minimum age: 18 - Ability to consent to study participation. - Written informed consent - Patients from the dental group practice of Dr. Dirheimer and Dr. Ludwig Ulm, Germany. - Subjective xerostomia: at least 6 on a VAS scale of 1 to 10 after waking AND at least 6 weeks of radiation therapy due to tumor disease in the head and neck region - Primary therapy at least 6 months, maximum 18 months ago

Exclusion criteria

Exclusion criteria: - Existing or planned pregnancy during the study - Current radiotherapy/chemotherapy or antibody therapy - Acute inflammatory oral disease/abscess - Change in medication with possible influence on salivary flow rates during the study

Design outcomes

Primary

Measure	Time frame
To investigate whether the use of Xylimelts adhesive tablets during the night induces subjective symptom relief (VAS 100mm) in patients with nocturnal dry mouth after irradiation in the head and neck region in a before-after comparison and in a comparison with the use of water.	—

Secondary

Measure	Time frame
To investigate whether the use of Xylimelts adhesive tablets during the night brings about an improvement with regard to the following study parameters in a before-after comparison as well as in comparison with the use of water: - 100 mm VAS Dry Mouth Scale. - Shahdad Questionnaire of symptomatic relief - Number of nocturnal awakenings - Objective test of saliva volume (modified umbrella test and WSS/UWSS) Documentation of side effects, adverse events, or (not expected) serious adverse events.	—

Measure

Time frame

To investigate whether the use of Xylimelts adhesive tablets during the night brings about an improvement with regard to the following study parameters in a before-after comparison as well as in comparison with the use of water: - 100 mm VAS Dry Mouth Scale. - Shahdad Questionnaire of symptomatic relief - Number of nocturnal awakenings - Objective test of saliva volume (modified umbrella test and WSS/UWSS) Documentation of side effects, adverse events, or (not expected) serious adverse events.

—

Countries

Germany

Contacts

Public ContactGreta Barbe

Poliklinik für Zahnerhaltung und Parodontologie, Zentrum für Zahn- Mund und Kieferheilkunde, Uniklinik Köln

greta.barbe@uk-koeln.de+49 221 478-7174

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026