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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05481580
Other study ID # Perio2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date June 30, 2023

Study information

Verified date July 2022
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Patients with this type of restorations will be identified and a non-interventional clinical and radiographic analysis will be conducted.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Policlinico Duilio Casula, AOU Cagliari Monserrato CA

Sponsors (1)

Lead Sponsor Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. Review. — View Citation

Hou GL, Tsai CC. Relationship between periodontal furcation involvement and molar cervical enamel projections. J Periodontol. 1987 Oct;58(10):715-21. — View Citation

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. Review. — View Citation

Wang HL, Burgett FG, Shyr Y. The relationship between restoration and furcation involvement on molar teeth. J Periodontol. 1993 Apr;64(4):302-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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