Randomized double-blind crossover study to compare the efficacy of GUM HYDRAL Mouth Wash and Gel versus Biotene Mouth wash and Gel on medication-induced xerostomia (MPG23b)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009685

Enrollment

Registered

2015-11-18

Start date

2016-01-04

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

Medication-induced dry mouth T88.7

Interventions

Group 1: 20 patients with medication-induced xerostomia (minimal 4 points on a 10 points Visual analog Scale) receive at day 1 Product A (Biotene) mouthrinse and gel for usage for a 4 weeks duration.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Minimum age: at least 18 years of age Written informed consent Daily intake of at least one drug with medication-induced xerostomia as declared side effect in the product insert (the patient will be asked at the beginning of the trial about taken drug names and application rates) and as it is stated in the attached Hydral Medications List and in (Screebny et al.) Subjective xerostomia: Minimum level of xerostomia on a VAS scale: 4 of 10 Minimum number of teeth: 4

Exclusion criteria

Exclusion criteria: Any allergic or undesired condition stated in the case history on one of the study product ingredients Pregnancy or planned pregnancy during the study Current or anamnestic radiation therapy or chemotherapy Current or anamnestic parotid malignancy Current or anamnestic head/neck malignancy Current or anamnestic surgery in the head/neck region Sjögren’s syndrome Other medical reasons for xerostomia without drug intake Current daily intake of symptom alleviating products against xerostomia (other than high frequent water intake) Smoking of more than 10 cigarettes/day

Design outcomes

Primary

Measure	Time frame
The subjektive improvement of the xerostomic symptoms are measured via the Visual Analoge Scale at baseline and after 4 weeks of utilisation of the study products	—

Secondary

Measure	Time frame
quantitative amount of salive (Measurement of the saliva amount) and oral health related quality of life (OHIPG 14) are measured at baseline and after 4 weeks of usage of the study products Additionally, at baseline and after 4 weeks of usage of the study products will be measured: Xerostomia questionnaire, a questionnaire concerning the xerostomia related Quality of life, a questionnaire concerning the subjective efficy of the used products and clinical Parameters (organoleptic scale, Plaqueindex, Gingivitisindex, Mukositisindex, pH)	—

Measure

Time frame

quantitative amount of salive (Measurement of the saliva amount) and oral health related quality of life (OHIPG 14) are measured at baseline and after 4 weeks of usage of the study products Additionally, at baseline and after 4 weeks of usage of the study products will be measured: Xerostomia questionnaire, a questionnaire concerning the xerostomia related Quality of life, a questionnaire concerning the subjective efficy of the used products and clinical Parameters (organoleptic scale, Plaqueindex, Gingivitisindex, Mukositisindex, pH)

—

Countries

Germany

Contacts

Public ContactGreta Barbe

Uniklinik KölnAbteilung für Zahnerhaltung und Parodontologie

anna.barbe@uk-koeln.de0221-478-96743

Outcome results

None listed

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