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

NCT06929676 | Enrolling By Invitation DMC

• 1 other identifier: 86301125.4.0000.5418
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periodontal Diseases; Periodontitis

Keywords

periodontal diseases; Tooth Mobility; Periodontal Splints

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

Tooth Mobility Assessment

EXPERIMENTAL

Evaluation of dental mobility before and after non-surgical periodontal treatment, after stabilization by periodontal splints.

Procedure: Periodontal Treatment; Other: assessment of tooth mobility before and after periodontal treatment; Other: Evaluation of Clinical Parameters

Interventions

Periodontal Treatment PROCEDURE

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

Tooth Mobility Assessment

assessment of tooth mobility before and after periodontal treatment OTHER

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

Tooth Mobility Assessment

Evaluation of Clinical Parameters OTHER

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

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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Tooth Mobility

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 16, 2025
• Study Start: April 30, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

BR (1)