Periodontal DiseaseNCT06600867
Method for Measuring Dental Mobility and Displacement Force
A study testing Tooth mobility assessment in people with Periodontal Disease and Mobility, Tooth, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease, Mobility, Tooth
- What is being tested?
- Tooth mobility assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Crossbite or end-to-end bite.
- Bruxism.
- Implants adjacent to the tooth with mobility.
- Extreme mobility.
- Occlusal trauma.
- Patients requiring prophylactic antibiotics.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas
Piracicaba, São Paulo, 13414903
About this study
Official title: Evaluation of a Method for Measuring Dental Mobility and Displacement Force in Incisors With Periodontal Support Loss
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.
Read more
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.
Read the detailed 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.
- Conditions
- Periodontal Disease, Mobility, Tooth
- Being tested
- Tooth mobility assessment
- Keywords
- Periodontal Disease, Tooth Mobility, Periodontal Attachment Loss
- Medical subject headings
- Periodontal Diseases, Tooth Mobility, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth mobility assessmentDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Tooth Mobility Assessment | Experimental | Tooth Mobility and Applied Force Assessment Receives: Diagnostic Test: Tooth mobility assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately before the clinical assessment
Tooth Mobility: labial-lingual/palatal displacement (mm)
Assess the displacement of lower and upper incisors with dental mobility
Measured: immediately before the clinical assessment
Secondary outcomes (1)
Compare two instruments for measuring force
adapted tensiometer versus dynamometer
Measured: At the end of the 3-months study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Aug 2024
- Primary completion21 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive interventional clinical study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enilson Antonio Sallum, University of Campinas, Brazil
- Investigators
- Larissa A Fatinanzi, MsC, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600867
- Sponsor's protocol ID
- 81525124.9.0000.5418
- Status last verified
- May 2025
- First submitted
- 11 Sep 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Method for Measuring Dental Mobility and Displacement Force in Incisors With Periodontal Support Loss
- ClinicalTrials.gov ID
- NCT06600867
- Acronym / sponsor ID
- 81525124.9.0000.5418
- Conditions
- Periodontal Disease, Mobility, Tooth
- Keywords
- Periodontal Disease, Tooth Mobility, Periodontal Attachment Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive interventional clinical study
| Arm | Type | Receives |
|---|---|---|
| Tooth Mobility Assessment | Experimental | Diagnostic Test: Tooth mobility assessmentTooth Mobility and Applied Force Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Crossbite or end-to-end bite.
- Bruxism.
- Implants adjacent to the tooth with mobility.
- Extreme mobility.
- Occlusal trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth mobility assessmentThe 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). | Diagnostic test | Tooth Mobility Assessment |
Primary outcome
Tooth mobility: force control (gf)
Time frame: immediately before the clinical assessment
Assess the force (gf) needed for each patient/tooth to achieve the diagnostic displacement of lower and upper incisors exhibiting dental mobility
Tooth Mobility: labial-lingual/palatal displacement (mm)
Time frame: immediately before the clinical assessment
Assess the displacement of lower and upper incisors with dental mobility
1 secondary outcome
Compare two instruments for measuring force
Time frame: At the end of the 3-months study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa A Fatinanzi, MsC principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth mobility assessment in people with Periodontal Disease and Mobility, Tooth, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth mobility: force control (gf) (time frame: immediately before the clinical assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.