ClinicalTrials.gg
Status unknownNCT05481580Updated Aug 1, 2022

Restorations and Furcation Involvement on Molars

An observational study in Furcation Defects, sponsored by University of Cagliari. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by University of Cagliari · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Furcation Defects

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Keywords

  • Furcation Defects
  • Dental Restoration, Permanent
  • Dental Crowns
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In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

Browse Furcation Defects studies →

Lead sponsor

University of Cagliari is the lead sponsor of 85 studies on the registry; 17 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testPeriodontal 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

    Also known as: Radiograph

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What researchers measure

Primary outcomes

  1. Presence of furcation

    The presence of bone resorption between the roots of the molar

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

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Study locations

1 site
  • Policlinico Duilio Casula, AOU Cagliari
    Monserrato, CA 09042, Italy
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References and documents

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. PubMed 26932323 ↗
  • 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. PubMed 8483093 ↗
  • 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. PubMed 3478466 ↗
  • 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. PubMed 2406294 ↗

Individual participant data

Plan to share: Yes — Individual participant data will be shared in a publication after the end of the study

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Data will be submitted for publication right after the analysis of the outcomes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05481580
Lead sponsor
University of Cagliari
Responsible party
Nicola Alberto Valente, DDS, MS, PhD (Assistant Professor, University of Cagliari) — Principal investigator
First posted
Aug 1, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Aug 1, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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