Localized Bite Force and Functional Recovery of Masticatory Function Following Primary and Revision Endodontic Therapy in Older Adults: A Prospective Three-Arm Cohort Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040547

Enrollment

Registered

2026-06-12

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

K04

Interventions

Group 1: 25 patients aged = 55 years with a planned primary endodontic treatment of a posterior tooth. Masticatory function and bite force are assessed at five standardized measurement time points: T0

Eligibility

Sex/Gender

All

Age

55 Years to No maximum

Inclusion criteria

Inclusion criteria: Group A (25 patients): scheduled primary endodontic treatment of a posterior tooth Group B (25 patients): scheduled endodontic retreatment of a posterior tooth Group C control (25 patients): absence of any pathology requiring treatment

Exclusion criteria

Exclusion criteria: -Presence of severe systemic diseases with an impact on masticatory performance -Presence of severe craniomandibular dysfunction -Complete edentulism or insufficient occluding dentition and/or inadequate prosthesis retention F-ailure to comply with scheduled follow-up (recall) visits

Design outcomes

Primary

Measure	Time frame
WHAT: Change in objective masticatory efficiency (OME) measured via color mixing of chewing gum (Hue-Check Gum Test; Variance of Hue, VOH) Change in isometric maximal bite force (N) WHEN (measurement time points): T0: Baseline (initial examination) T1: immediately before start of treatment T2: 1 week after completion of endodontic therapy T3: 3 months after therapy T4: 6 months after therapy (control group: T0 and T4) HOW: Masticatory efficiency (OME): Hue-Check Gum Test (bi-colored chewing gum), standardized chewing cycles (˜20), followed by compression, scanning (300 dpi), and computer-based analysis of color mixing using ViewGum software (calculation of VOH as a measure of dispersion of hue values). Bite force: Isometric bite force measurement using a piezoelectric sensor (T-Scan system + I-Scan software), three repeated maximal bites over 3–4 seconds with standardized pauses; force output in Newtons after calibration.	—

Measure

Time frame

WHAT: Change in objective masticatory efficiency (OME) measured via color mixing of chewing gum (Hue-Check Gum Test; Variance of Hue, VOH) Change in isometric maximal bite force (N) WHEN (measurement time points): T0: Baseline (initial examination) T1: immediately before start of treatment T2: 1 week after completion of endodontic therapy T3: 3 months after therapy T4: 6 months after therapy (control group: T0 and T4) HOW: Masticatory efficiency (OME): Hue-Check Gum Test (bi-colored chewing gum), standardized chewing cycles (˜20), followed by compression, scanning (300 dpi), and computer-based analysis of color mixing using ViewGum software (calculation of VOH as a measure of dispersion of hue values). Bite force: Isometric bite force measurement using a piezoelectric sensor (T-Scan system + I-Scan software), three repeated maximal bites over 3–4 seconds with standardized pauses; force output in Newtons after calibration.

—

Secondary

Measure	Time frame
Bite force (N) from T0–T4 Chewing comfort Subjective assessment of masticatory ability: clinic-internal questionnaire assessing temporomandibular disorders (TMD/CMD), reduced mandibular mobility, and functional impairment	—

Countries

Germany

Contacts

Public ContactAnna Greta Barbe

Zentrum für Zahn-, Mund- und Kieferheilunde, Abteilung für Zahnerhaltung und Parodontologie

greta.barbe@uk-koeln.de+49 221 478 96743

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026