The effectiveness of two aids for gingivitis prophylaxis and plaque removal in patients with fixed orthodontic appliances

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035086

Enrollment

Registered

2024-09-17

Start date

2024-10-01

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

The oral hygiene situation is determined at each appointment. The Papilla Bleeding Index (PBI) and a modified plaque index according to Silness & Loe are used for this purpose. The plaque index (PI) according to Silness & Loe is used to assess different areas separately.

Interventions

Group 1: Comparison group uses I-Prox single-tuft brushes Group 2: Test group uses Philips Power Flosser

Eligibility

Sex/Gender

All

Age

11 Years to 20 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria • Subjects with MB appliances • Age: 11-20 years, teeth of the 2nd dentition • Submission of the signed consent form of the subject (for 18-year-olds) or the legal guardian • Plaque index =1

Exclusion criteria

Exclusion criteria: Exclusion criteria The following criteria lead to exclusion from the clinical study: • severe general illnesses • subjects with physical and/or mental disabilities that limit manual and cognitive abilities and therefore make comparability impossible • allergic reactions to the substances used in the study (e.g. polishing paste, plaque elevator) • unsigned consent form • gingival hyperplasia that extends to the cervical bracket surface • lack of compliance, so that it cannot be guaranteed that the subject will adhere to the study protocol.

Design outcomes

Primary

Measure	Time frame
1. After six weeks of using the Power Flosser (Philipps), a lower level of gingivitis (PBI index) is expected compared to using I-Prox P (Miradent). 2. After six weeks of using the Power Flosser, a lower level of biofilm infestation (plaque index) is expected.	—

Secondary

Measure	Time frame
Another benefit is that the subjects are given detailed instructions on how to clean the fixed orthodontic appliances in every session in order to prevent gingivitis and caries. The new findings gained through the study help to improve oral hygiene measures at home and promote oral health. A growing awareness of more demanding dental care during multi-band treatment is made understandable to the subjects and is intended to encourage self-reflection.	—

Measure

Time frame

Another benefit is that the subjects are given detailed instructions on how to clean the fixed orthodontic appliances in every session in order to prevent gingivitis and caries. The new findings gained through the study help to improve oral hygiene measures at home and promote oral health. A growing awareness of more demanding dental care during multi-band treatment is made understandable to the subjects and is intended to encourage self-reflection.

—

Countries

Germany

Contacts

Public ContactMozghan Bizhang

Universität Witten/Herdecke

Mozghan.Bizhang@uni-wh.de02302/926-653

Outcome results

None listed

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