Randomized double-blind crossover study to compare the efficacy of Dr. Wolff Mouth Gel versus Biotène® Oralbalance Mouth Gel on xerostomia patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013281

Enrollment

Registered

2017-12-27

Start date

2018-01-08

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

Xerostomia K11.7 R68.2

Interventions

Group 1: 32 patients with subjective dry mouth (VAS greater than or equal to 4) receive 4 appointments (baseline 1, follow-up 1, baseline 2, follow-up 2) at weekly intervals at the University Dental C

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Minimum age: 18 -Written declaration of consent -Subject Xerostomia (between 4 and 8 on a VAS scale from 1 to 10) -Minimal number of teeth: 4

Exclusion criteria

Exclusion criteria: Any allergic or past history, undesirable condition, based on components of the study products. Existing or planned pregnancy during the study Current radiotherapy or chemotherapy Current parotid gland tumor Current head / neck tumor Current daily intake of symptom-alleviating products for xerostomia (except frequent water intake)

Design outcomes

Primary

Measure	Time frame
The subjective improvement of dry mouth after application of Dr. Wolff mouth gels measured using the Visual Analogue Scale at baseline 1/2 and after 1-week (follow-up 1/2). Comparison of Dr. Wolff mouth gel and Biotene gel regarding the improvement of subjective dry mouth: Mean difference in xerostomic VA scales collected in baseline examinations 1 and 2 and follow-up examinations 1 and 2 (cross-over).	—

Measure

Time frame

The subjective improvement of dry mouth after application of Dr. Wolff mouth gels measured using the Visual Analogue Scale at baseline 1/2 and after 1-week (follow-up 1/2). Comparison of Dr. Wolff mouth gel and Biotene gel regarding the improvement of subjective dry mouth: Mean difference in xerostomic VA scales collected in baseline examinations 1 and 2 and follow-up examinations 1 and 2 (cross-over).

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Secondary

Measure	Time frame
Subjective assessment of the following parameters on the basis of VA scales: - Retention in mouth - taste - consistency - Application and distributability - moistening effect (formation of a moisture film) - Quantification of the effect length (sustainability) - Fresh breath - Reduction of the need for drinking - side effects - Willingness to pay The survey will take place at appointment 1 (baseline 1) after the one-time administration by Dr. Wolff mouth gel and Biotene mouth gel and after the one-week use of the products (follow-up 1 and follow-up 2).	—

Measure

Time frame

Subjective assessment of the following parameters on the basis of VA scales: - Retention in mouth - taste - consistency - Application and distributability - moistening effect (formation of a moisture film) - Quantification of the effect length (sustainability) - Fresh breath - Reduction of the need for drinking - side effects - Willingness to pay The survey will take place at appointment 1 (baseline 1) after the one-time administration by Dr. Wolff mouth gel and Biotene mouth gel and after the one-week use of the products (follow-up 1 and follow-up 2).

—

Countries

Germany

Contacts

Public ContactLena Ludwar

Poliklinik für Zahnerhaltung und Parodontologie Uniklinik Köln

lena.ludwar@uk-koeln.de+49 177 5137748

Outcome results

None listed

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