Restorations and Furcation Involvement on Molars

Relationship Between Molar Restoration and Furcation Involvement

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Furcation Defects
• Intervention / Treatment: Diagnostic test: Periodontal probing

Detailed Description

Patients who have a molar tooth reconstructed with a second class filling according to Black, or a with crown or that is abutment of a prosthetic bridge will be included in the study provided they have at least one other intact molar.

The molars included in the study do not have to be wisdom teeth. In these patients, in addition to the presence of furcations (bone resorption in the space between the roots), the probing depth (PD), the loss of clinical attachment (CAL), bleeding on probing ( BOP), mobility, width of the keratinized tissue, the length of the root trunk (measured radiographically), the presence or absence of endodontic treatments (evaluated on the radiography), the anatomy of the roots (widely separated, fused, separated but fused) and the presence of enamel projections will be recorded.

Data will be analyzed with utilizing Pearson chi-square and the pair-wise t test.

The analysis of these data will provide us with evidence on the influence that interproximal restorations and fixed prostheses, in the presence of other co-factors, have on the presence of furcations in molars.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • CA
    • Monserrato, CA, Italy, 09042
      • Policlinico Duilio Casula, AOU Cagliari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Restored; Molars with a 2nd class restoration or a crown	Diagnostic test: Periodontal probing; 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; Other Names: Radiograph
Non-restored; Molars with no restorations	Diagnostic test: Periodontal probing; 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; Other Names: Radiograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Cagliari

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Furcation Defects; Dental Restoration, Permanent; Dental Crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Furcation Defects
• Other Study ID Numbers: Perio2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data will be shared in a publication after the end of the study
• IPD Sharing Time Frame: Data will be submitted for publication right after the analysis of the outcomes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No