NCT05481580

Brief Summary

The aim of this study will be to analyze the relationship between the presence of second class restorations (interproximal fillings) or prostheses (crowns, bridges) on molar teeth and the presence of bone resorption between the roots of the latter. Patients with this type of restorations will be identified and a non-interventional clinical and radiographic analysis will be conducted.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

July 25, 2022

Last Update Submit

July 28, 2022

Conditions

Keywords

Furcation DefectsDental Restoration, PermanentDental Crowns

Outcome Measures

Primary Outcomes (1)

  • Presence of furcation

    The presence of bone resorption between the roots of the molar

    At the time of evaluation, the first time the patients is seen (time 0)

Study Arms (2)

Restored

Molars with a 2nd class restoration or a crown

Diagnostic Test: Periodontal probing

Non-restored

Molars with no restorations

Diagnostic Test: Periodontal probing

Interventions

Periodontal probingDIAGNOSTIC_TEST

The teeth involved will be probed to assess probing depth, presence of furcation, bleeding. A radiograph will be taken to assess the length of the root trunk and the presence of root canal treatment

Also known as: Radiograph
Non-restoredRestored

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Periodontal maintenance patients who have restored and non-restored molars present both with and without furcation involvement.

You may qualify if:

  • Patients who have molars both with and without restorations
  • Restorations presents for at least 5 years

You may not qualify if:

  • Patients who do not want to undergo evaluation
  • Patients who cannot undergo radiation (pregnant women)
  • Patients who do not have at least one other unrestored molar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Duilio Casula, AOU Cagliari

Monserrato, CA, 09042, Italy

Location

Related Publications (4)

  • Nibali L, Zavattini A, Nagata K, Di Iorio A, Lin GH, Needleman I, Donos N. Tooth loss in molars with and without furcation involvement - a systematic review and meta-analysis. J Clin Periodontol. 2016 Feb;43(2):156-66. doi: 10.1111/jcpe.12497. Epub 2016 Feb 12.

    PMID: 26932323BACKGROUND
  • Wang HL, Burgett FG, Shyr Y. The relationship between restoration and furcation involvement on molar teeth. J Periodontol. 1993 Apr;64(4):302-5. doi: 10.1902/jop.1993.64.4.302.

  • Hou GL, Tsai CC. Relationship between periodontal furcation involvement and molar cervical enamel projections. J Periodontol. 1987 Oct;58(10):715-21. doi: 10.1902/jop.1987.58.10.715.

  • Brunsvold MA, Lane JJ. The prevalence of overhanging dental restorations and their relationship to periodontal disease. J Clin Periodontol. 1990 Feb;17(2):67-72. doi: 10.1111/j.1600-051x.1990.tb01064.x.

MeSH Terms

Conditions

Furcation Defects

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 1, 2022

Study Start

September 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared in a publication after the end of the study

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be submitted for publication right after the analysis of the outcomes

Locations