Method for Measuring Dental Mobility and Displacement Force

NCT06600867 | Completed

• 1 other identifier: 81525124.9.0000.5418
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the use of a new method for measuring tooth mobility, which includes control of force (gf) and labial/lingual/palatal displacement (mm) of upper and lower incisors with tooth mobility. It will take place during a single assessment session at the clinic of the Piracicaba Dental School (FOP-Unicamp), supervised by the research student Larissa Alexandra Fatinanzi and Prof. Dr. Enílson Antônio Sallum. The evaluation will be conducted in person during regular clinical appointments, without requiring additional travel or extended time beyond what is planned. The research will be conducted over two different days of appointments, scheduled on the same day and time as regular clinical appointments, occupying 30 minutes to 1 hour each. Day 1: A molding (copy of the tooth) will be performed. Based on this step, a customized instrument will be made (necessary for evaluating the tooth with mobility). Customized Instrument: The materials used will include: acetate plate (similar to a teeth whitening tray); endodontic spacer (used in root canal treatment); tensiometer and dynamometer (used in orthodontics to measure force); and caliper (a device for measuring in millimeters). Day 2: Evaluations will be conducted, including mobility (tooth with movement), periodontal parameters (examination of the gums and tooth support system), and completion of a questionnaire with basic questions relating daily life to the clinical situation (tooth with movement). The assessment of dental mobility involves moving the tooth forward and backward, similar to routine clinical practice. The amount of tooth movement will be measured in millimeters using the customized instrument. Additionally, a tensiometer and dynamometer will be used to measure the force. The force applied by the instruments will not harm the tooth with mobility. Two sets of dental mobility tests will be performed, with a 1-minute interval between them. The instruments used pose no risk to oral tissues, are employed in dental treatments, and are non-invasive. All evaluations will be carried out on the same day of the appointment.

Conditions

Periodontal Disease; Mobility, Tooth

Keywords

Periodontal Disease; Tooth Mobility; Periodontal Attachment Loss

Outcome Measures

Primary Outcomes (2)

• Tooth mobility: force control (gf)

  Assess the force (gf) needed for each patient/tooth to achieve the diagnostic displacement of lower and upper incisors exhibiting dental mobility

  immediately before the clinical assessment

• Tooth Mobility: labial-lingual/palatal displacement (mm)

  Assess the displacement of lower and upper incisors with dental mobility

  immediately before the clinical assessment

Secondary Outcomes (1)

• Compare two instruments for measuring force

  At the end of the 3-months study

Other Outcomes (1)

• Quality of life (OHIP-14) questionnaire

  At the end of the 3-months study

Study Arms (1)

Tooth Mobility Assessment

EXPERIMENTAL

Tooth Mobility and Applied Force Assessment

Diagnostic Test: Tooth mobility assessment

Interventions

Tooth mobility assessment DIAGNOSTIC_TEST

The examiner, holding the instruments (two clinical mirror handles), will apply labial/lingual or labial/palatal displacement movements using the subjective technique, just as routinely done. Using the endodontic spacer and the stop, the deflection will be measured in millimeters. Subsequently, the examiner, with the instruments in hand (tensiometer and dynamometer), will apply labial/lingual and labial/palatal displacement movements, determining the force required to achieve the same displacement previously established by the subjective method (reference/limit of displacement).

Tooth Mobility Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Periodontitis Stage II, III, and IV (grades A, B,C) and with periodontal pockets ≥ 4 mm.
• Anterior teeth (13-23 and 33-43) with dental mobility (grade 1, 2, or 3).
• Aged ≥ 18 years.

You may not qualify if:

• Crossbite or end-to-end bite.
• Bruxism.
• Implants adjacent to the tooth with mobility.
• Extreme mobility.
• Occlusal trauma.
• Patients requiring prophylactic antibiotics.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas

Piracicaba, São Paulo, 13414903, Brazil

Location

MeSH Terms

Conditions

Periodontal Diseases; Tooth Mobility; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Larissa A Fatinanzi, MsC

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of the Periodontology Department

Model Details: Descriptive interventional clinical study

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: August 10, 2024
• Primary Completion: March 21, 2025
• Study Completion: April 30, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

BR (1)