Furcation DefectsNCT05481580
Restorations and Furcation Involvement on Molars
An observational study of Furcation Defects, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects
- What is being tested?
- Periodontal probing
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Periodontal maintenance patients who have restored and non-restored molars present both with and without furcation involvement.
Who may be able to join
- Patients who have molars both with and without restorations
- Restorations presents for at least 5 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Furcation Defects
- Being tested
- Periodontal probing
- Keywords
- Furcation Defects, Dental Restoration, Permanent, Dental Crowns
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal probingDiagnostic test
Also called Radiograph
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
| Study group | Role | What they receive |
|---|---|---|
| Restored | Molars with a 2nd class restoration or a crown Receives: Diagnostic Test: Periodontal probing | |
| Non-restored | Molars with no restorations Receives: Diagnostic Test: Periodontal probing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of furcation
The presence of bone resorption between the roots of the molar
Measured: At the time of evaluation, the first time the patients is seen (time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481580
- Sponsor's protocol ID
- Perio2
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared in a publication after the end of the study
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 26932323Wang 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 8483093Hou 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 3478466Brunsvold 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Molar Restoration and Furcation Involvement
- ClinicalTrials.gov ID
- NCT05481580
- Acronym / sponsor ID
- Perio2
- Conditions
- Furcation Defects
- Keywords
- Furcation Defects, Dental Restoration, Permanent, Dental Crowns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restored | – | Diagnostic Test: Periodontal probingMolars with a 2nd class restoration or a crown |
| Non-restored | – | Diagnostic Test: Periodontal probingMolars with no restorations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Periodontal maintenance patients who have restored and non-restored molars present both with and without furcation involvement.
Key inclusion criteria (2 listed)
- Patients who have molars both with and without restorations
- Restorations presents for at least 5 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal probingAlso: RadiographThe 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 | Diagnostic test | Non-restored, Restored |
Primary outcome
Presence of furcation
Time frame: At the time of evaluation, the first time the patients is seen (time 0)
The presence of bone resorption between the roots of the molar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 26932323Nibali 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.
- Results publication: PubMed 8483093Wang 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.
- Results publication: PubMed 3478466Hou 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.
- Results publication: PubMed 2406294Brunsvold 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared in a publication after the end of the study
Related trials for Furcation Defects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Furcation Defects, run by University of Cagliari at 1 site in Italy.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. 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 Italy. 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?
Results are not available in the source record.
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?
Presence of furcation (time frame: At the time of evaluation, the first time the patients is seen (time 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481580, which also lists 4 linked publications.
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 1 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.