Influence of a brushing app on the oral hygiene at home during non-surgicalperiodontal therapy phase.

Not Applicable

Recruiting

• Conditions: K05; Gingivitis and periodontal diseases

• Registration Number: DRKS00031539
• Lead Sponsor: Klinik für Zahnerhaltungs und Parodontologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

written informed consent for study participation, specifically of data recording during oral
hygiene at home by the study toothbrushes.
- generalized periodontitis = Stage I.
- patient age 18 to 80 years
- are in good general health
- Have at least 14 teeth (excluding implants);
- agree not to participate in any other oral care clinical trial during the study period;
- agree not to use other toothbrushes and dentifrices than the study products during the
study period;
- Subject will use interdental space hygiene aids such as dental floss, interdental brushes,
etc., but agrees not to use or change other oral hygiene products, including whiteners, etc.;
- agree to follow study procedures and attend all scheduled clinical visits;
- agree to refrain from elective dental treatments during the study, such as teeth whitening,
orthodontic tooth movement, etc., that are not part of the study protocol;
- availability of an internet and app-enabled smartphone or tablet.

Exclusion Criteria

- Patient is younger than 18 or older than 80 years of age;
- failure of patient to give informed consent for student treatment during non-surgical therapy;
- currently or enrolled within the past 30 days in another oral care clinical trial;
- dentists or dental students, dental assisting personnel;
- disease, condition, or medical condition that could reasonably be expected to interfere with the study procedures or affect or prevent the safe conduct of the study (e.g., chemotherapy, AIDS, diabetes mellitus, epilepsy, tremor, Parkinson's disease, dementia);
- physical limitations that might preclude normal oral hygiene;
- self-reported pregnancy or breastfeeding;
- taking medications for at least three consecutive days within the last 28 days that could affect the outcome of the study (e.g., anti-inflammatory medications, Dilantin, NSAIDs);
- current use of medications that may cause gingival hyperplasia (e.g., calcium antagonists such as nifedepine, hydantoin, ciclosporin);
- has a known allergic reaction to dental materials or oral hygiene products;
- who require medication of any kind prior to dental procedures;
- evidence of major hard or soft tissue lesions or trauma or carious lesions requiring restorative treatment;
- active orthodontic treatment;
- smokers with >10 cigs/d.;
- Patients who do not own a smartphone/tablet;
- professional tooth cleaning within the last 4 weeks prior to study entry

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of gingival bleeding index (?GBI) collected at baseline (1), visits (2-5), endpoint (6) each weekly

Secondary Outcome Measures

Name	Time	Method
Change in time spent on oral hygiene, brushing-systematic, -motivationand -behavior, pocket depths (?PD), recessions (?Rez), bleeding onprobing (?BOP), calculated clinical attachment level (?CAL), total plaqueindex (?PCR) collected at baseline (1), visits (2-5), endpoint (6) each weekly