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Periodontal DiseasesNCT06929676

Assessment of Tooth Mobility After Non-surgical Periodontal Treatment Followed by Tooth Splinting

A study testing Periodontal Treatment, assessment of tooth mobility before and after periodontal treatment and Evaluation of Clinical Parameters in people with Periodontal Diseases and Periodontitis, run by University of Campinas, Brazil at 1 site in Brazil.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This clinical study aims to investigate changes in tooth mobility after non-surgical periodontal treatment in anterior teeth with mobility. Twenty patients from the Piracicaba Dental School - Unicamp, diagnosed with stage III or IV periodontitis and grade 2 or 3 tooth mobility, will be selected. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontal Diseases, Periodontitis
What is being tested?
Periodontal Treatment, assessment of tooth mobility before and after periodontal treatment and Evaluation of Clinical Parameters
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
30 Apr 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who cannot join

  • Crossbite or edge-to-edge
  • Absence of posterior occlusal contact
  • Bruxism
  • Implants adjacent to the tooth with mobility
  • Extreme mobility
  • Patients requiring prophylactic antibiotics
  • Smokers
  • Diabetics

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site
  • Piracicaba Dental School, State University of Campinas

    Piracicaba, São Paulo, 13414-903

Other trials in Brazil

About this study

This clinical study aims to investigate changes in tooth mobility after non-surgical periodontal treatment in anterior teeth with mobility. Twenty patients from the Piracicaba Dental School - Unicamp, diagnosed with stage III or IV periodontitis and grade 2 or 3 tooth mobility, will be selected. Mobility will be assessed using an innovative method involving a customized plate and a tensiometer adapted to apply controlled force.

Initially, participants will undergo a detailed clinical examination, including periodontal evaluation, occlusal analysis, and gingival crevicular fluid collection. After periodontal treatment, which will involve scaling and root planing, mobility will be reassessed after 60 days. Then, a temporary fiber-reinforced resin splint will be applied to the affected teeth and maintained for another 60 days. At the end of the period, the splint will be removed, and new assessments will be conducted.

The study will also analyze the impact of treatment on patients' quality of life (OHIP-14) and the levels of bone and inflammatory markers (OPG, RANK/RANKL, IL-1β, and TNF-α). The findings are expected to provide a better understanding of the response of mobile teeth to periodontal treatment and the role of splinting in stabilizing periodontal tissues.

Read the detailed description

Study Location and Participants

The study will be conducted at the Specialization Clinic of the Piracicaba Dental School (FOP-Unicamp). Participants will be voluntary patients receiving clinical care at the Undergraduate Clinic of FOP, diagnosed with stage III or IV periodontitis with grades A, B, or C (Papapanou et al., 2018). The inclusion criteria are: periodontal pockets ≥ 4 mm, anterior teeth with mobility (grade 2 or 3) and periodontal attachment loss, and participants of both sexes aged 18 years or older.

All participants will receive treatment in the sextant of the affected tooth/teeth by the researcher, while periodontal treatment of the remaining sextants will be performed as part of the activities of the Undergraduate Clinic at FOP.

Procedure Phase 1: Assessment of Mobility, Clinical Parameters, and Bone Markers Before Non-Surgical Periodontal Treatment Clinical Parameters Initially, volunteers will receive information regarding the etiology and pathogenesis of periodontal diseases. A detailed periodontal evaluation will be performed on the affected sextant (2/5), assessing probing depth (PD) and clinical attachment level (CAL) at six sites per tooth using a calibrated periodontal probe (PCP-UNC 15 tip, Hu-Friedy, Chicago, IL). A complementary periapical radiographic examination will be performed (regions 13-23/33-43), along with the administration of the OHIP-14 questionnaire.

Fabrication of the Tooth Mobility Assessment Device Customized Tray Plate A customized tray plate will be fabricated using Polyethylene Terephthalate Glycol (PET-G) (Bio-Art; Bio-Art Soluções Inteligentes), based on a plaster model of the patient's dentition with a thickness of 1.0 mm. A 3 mm resin layer will be applied over the mobile tooth in the plaster model, creating space on the buccal, lingual/palatal, and incisal surfaces. Relief areas will be made in the acetate plate on the surfaces of mobile teeth, in a circular shape, with diameters larger than 10 mm to allow for displacement force application and measurement.

Instrumentation - Displacement Measurement The instrument chosen and adapted for this research is the Orthodontic Tensiometer (Morelli Orthodontics, Sorocaba/SP, Brazil). Force measurements are presented in gram-force (gf), ranging from 25 gf to 250 gf, with additional readings of 6.25 gf and 12.5 gf. The adapted instrument has a calibration certificate with a precision margin of ±10%, as in the original model.

Displacement will be measured in millimeters using the Absolute digital caliper (Mitutoyo, Illinois, USA), an instrument with a resolution of 0.01 mm/0.0005" and accuracy of ±0.03 mm/0.0015". Measurements will be marked using a silicone stop attached to the millimeter probe, where the instrument tip will touch the dental surface, and the stop will be moved to the external part of the plate on the buccal and lingual/palatal surfaces.

The use of the tensiometer in this study allows for the application of a specific and constant force for each tooth, which will be determined during the initial assessment.

Evaluation of Mobility and Clinical Parameters The examiner will assess the periodontal data of mobile teeth using the PCP-UNC 15 probe (Hu-Friedy), measuring PD and CAL at six sites per tooth. Premature contacts and occlusal interferences will be evaluated using articulating paper. The OHIP-14 questionnaire will be administered, followed by the adaptation of the acetate plate to the patient's arch to assess tooth mobility.

The examiner will apply buccal-lingual and buccal-palatal displacement forces using the tensiometer, determining the force necessary to achieve displacement. A minimum 1-minute interval will be observed between measurements to allow for periodontal ligament relaxation (Konermann et al., 2017). This relaxation time was selected based on investigations into stress relaxation during tooth loading (Komatsu, 2010).

Three measurements will be taken: initial, anterior deflection, and posterior deflection. The initial measurement will be subtracted from the displacement values. All measurements will be performed by the same examiner. Mobility will then be classified according to Lindhe and Nyman (1975), summing the anterior and posterior deflection values.

The displacement force value for each tooth will be specific to each patient and will serve as a standard for mobility reassessments throughout the study.

Gingival Crevicular Fluid Collection Gingival crevicular fluid (GCF) will be collected from each site using sterile absorbent paper cones, which will be carefully inserted into the gingival sulcus at the selected sites. The cone will remain in position for 30 seconds before samples are stored at -20°C in sterilized tubes.

Phase 2: Non-Surgical Periodontal Therapy This phase will involve non-surgical periodontal treatment, including patient visits for mechanical debridement sessions.

Plaque-retentive factors will be eliminated. Supragingival scaling (RDS) of the affected sextant will be performed using Gracey curettes and an ultrasonic scaler (Cavitron® Select) with tips for supragingival use.

Oral hygiene instructions (OHI) will be provided. Supragingival scaling will be performed as needed throughout the study, with careful handling of mobile teeth.

After 15 days, subgingival scaling and root planing (RD/AR) will be performed on sites with periodontal pockets.

Instrumentation will be carried out using Gracey curettes, Mini-Five Gracey curettes, and the Cavitron® Select ultrasonic scaler with tips for both supragingival and subgingival instrumentation. If necessary, occlusal adjustments will be performed on mobile teeth.

Oral hygiene instructions (OHI) will be reinforced at each follow-up visit, which will occur monthly until the study's conclusion.

Phase 3: Reassessment of Tooth Mobility and Clinical Parameters Sixty days after the non-surgical periodontal treatment, tooth mobility will be reassessed using the previously fabricated customized instrument. The same displacement force applied during the initial evaluation will be used for each specific tooth.

If displacement occurs, it will be measured in millimeters and converted into mobility grades according to Lindhe and Nyman (1975), summing the anterior and posterior deflection values.

Clinical parameters will be reassessed, including PD and CAL, which will be measured at six sites per tooth using the PCP-UNC 15 probe (Hu-Friedy). The OHIP-14 questionnaire will be re-administered. GCF samples will be collected again, following the same protocol, and stored at -20°C in sterilized tubes.

Phase 4: Splinting After non-surgical periodontal therapy, all patients will receive a fiber-reinforced composite resin splint (Interlig®, Angelus, 2016), following the manufacturer's instructions.

Clinical Procedure:

Isolation: Absolute isolation of the test tooth and adjacent teeth. Wedge Placement: Interproximal wedges. Surface Preparation: 37% phosphoric acid etching for 30 seconds, adhesive application, light-curing for 20 seconds per segment.

Resin Layer: First composite resin layer applied to lingual/palatal surfaces, followed by adaptation of Interlig fiber and light-curing for 20 seconds per segment.

Final Resin Layer: Applied to cover the fiber, light-cured for 20 seconds per segment.

Finishing and Polishing: Fine diamond burs to remove excess resin and polishing with sequential-grit finishing discs.

Occlusal Adjustment: If premature contacts are present. The splint will remain in place for 60 days, after which all clinical parameters will be reassessed, including radiographic examination.

Analysis of Bone Markers

GCF samples will be collected at three time points:

Baseline 60 days after non-surgical treatment 60 days after splinting removal Bone marker levels (OPG and RANK/RANKL) will be determined using specific kits and MAGpix® technology (MiraiBio, Alameda, CA, USA). These measurements will be analyzed individually using specialized software, with biomarker concentrations expressed in picograms per millimeter (pg/mm)

Being tested
Periodontal Treatment, assessment of tooth mobility before and after periodontal treatment, Evaluation of Clinical Parameters
Keywords
periodontal diseases, Tooth Mobility, Periodontal Splints
Medical subject headings
Periodontal Diseases, Periodontitis, Tooth Mobility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periodontal TreatmentProcedure or surgery

    Non-surgical periodontal treatment with scaling and root planing and dental splinting

  • assessment of tooth mobility before and after periodontal treatmentOther

    Evaluation of dental mobility with a customized device before and after non-surgical periodontal therapy and after stabilization by periodontal splints

  • Evaluation of Clinical ParametersOther

    Periodontal: probing depth, bone loss, CAL (clinical attachment level) Clinical: occlusal prematurities and collection of gingival crevicular fluid Questionnaire: quality of life (OHIP-14)

Study groups in NCT06929676
Study groupRoleWhat they receive
Tooth Mobility AssessmentExperimentalEvaluation of dental mobility before and after non-surgical periodontal treatment, after stabilization by periodontal splints.
Receives: Procedure: Periodontal Treatment; Other: assessment of tooth mobility before and after periodontal treatment; Other: Evaluation of Clinical Parameters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of dental mobility with a customized device before and after non-surgical periodontal therapy and after stabilization by periodontal splints

    Tooth mobility will be measured using a custom-made device specifically designed for each patient, allowing for standardized and reproducible assessment. Evaluations will occur at three time points: before the initiation of non-surgical periodontal therapy (baseline), at 60 days (after non-surgical treatment), and at 120 days (after splinting). This method ensures consistent positioning and pressure application during assessments. Each participant will serve as their own control, and the individual tooth will be considered the statistical unit.

    Measured: Baseline (Day 0), post- treatment non-surgical periodontal(Day 60), and post splinting (Day 120)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2025
  2. Study start30 Apr 2025
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06929676
Sponsor's protocol ID
86301125.4.0000.5418
Status last verified
May 2025
First submitted
31 Mar 2025
Last updated
20 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Periodontal Treatment, assessment of tooth mobility before and after periodontal treatment and Evaluation of Clinical Parameters in people with Periodontal Diseases and Periodontitis, 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 4 inclusion and 8 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: enrolling by invitation, 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?

This study is still under way. Results are not available in the source record yet.

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?

Evaluation of dental mobility with a customized device before and after non-surgical periodontal therapy and after stabilization by periodontal splints (time frame: Baseline (Day 0), post- treatment non-surgical periodontal(Day 60), and post splinting (Day 120)). 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.

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