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Method for Measuring Dental Mobility and Displacement Force

U

University of Campinas, Brazil

Status

Completed

Conditions

Periodontal Disease
Mobility, Tooth

Treatments

Diagnostic Test: Tooth mobility assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT06600867
81525124.9.0000.5418

Details and patient eligibility

About

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.

Full description

This will be a descriptive study. The population will consist of 20 volunteers diagnosed with periodontitis in stages II, III, and IV and grades A, B, and C, meeting the following inclusion criteria: periodontal pockets ≥ 4 mm, anterior teeth (regions 13-23 and/or 33-43) with dental mobility (grades 1, 2, or 3) and periodontal attachment loss, aged 18 years or older.

Patient selection will initially be conducted through the electronic medical records of patients undergoing treatment at the Piracicaba Dental School - Unicamp clinic.

The research will be carried out at the Periodontology Clinic of the Piracicaba Dental School (FOP-Unicamp), and the participation of volunteers will occur during regular clinical appointments, under the responsibility of the masters student Larissa Alexandra Fatinanzi and supervision of Prof. Dr. Enílson Antônio Sallum.

The method for evaluating dental mobility will include the use of a custom-made mold tray (PET-G; Bio-Art Soluções Inteligentes) for each patient with adaptations for displacement readings, an adapted tensiometer (Morelli, Orthodontics), a dynamometer (Zeusan, Campinas), two mirror handles, an endodontic spacer with a stop, and a caliper (Mitutoyo, Illinois, USA). Initially, the participant will receive the Informed Consent Form (ICF), and upon acceptance, the creation of the mold tray will begin based on the plaster model. In the next step, periodontal parameters (PS, NIC, bone loss in mm and % bone loss), premature contacts, and occlusal interferences will be assessed, along with the OHIP-14 (Oral Health Impact Profile), followed by dental mobility assessment using the conventional method with subjective force (mirror handles). The subjective force will determine the tooth displacement in millimeters (mm), which will then be used to establish the necessary objective force (measured by the tensiometer/dynamometer) to achieve the same displacement. Mobility will be classified according to Lindhe and Nyman classification (1975).

The chosen and adapted instrument for this research is the Orthodontic Tensiometer (Morelli Orthodontics, Sorocaba/SP, Brazil), with the inclusion of the Dynamometer (Zeusan, Campinas/SP - Brazil) for comparison purposes. The force measurements are presented in gf (gram-force), ranging from 25gf to 250gf (tensiometer) and 12.5g to 300g. Both instruments in this study will allow for the objective assessment of the routinely used subjective force and its possible relationship with clinical levels of attachment, in order to understand the magnitude of the force needed to displace a dental element with periodontal disease. The dynamometer will serve as a comparison tool and to confirm the accuracy of the tensiometer.

For statistical analysis, the comparison between the two techniques will be applied within the same group of subjects. Each volunteer will serve as their own control, reducing inter-subject variability. Normal distribution will be tested using the Shapiro-Wilk test. Comparisons will be made using Students t-test.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Tooth Mobility Assessment
Experimental group
Description:
Tooth Mobility and Applied Force Assessment
Treatment:
Diagnostic Test: Tooth mobility assessment

Trial contacts and locations

1

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Central trial contact

Enílson A Sallum, PhD

Data sourced from clinicaltrials.gov

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