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Prospective clinical study about gingival inflammation in teeth treated with dental contact lenses without cervical preparation. Evaluation by clinical parameters and inflammatory mediators present in the gingival fluid.

Ceramic veneers cemented on no prep teeth. Prospective and longitudinal clinical study of marginal adaptation and evaluation of periodontal behavior using biomarkers of gingival crevicular fluid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-65d7cc
Enrollment
Unknown
Registered
2020-02-12
Start date
2015-09-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

Interventions

The behavior of periodontal tissue will be evaluated by analyzing the quantity of biomarkers and the volume of Crevicular Gingival Fluid with further verification of the adaptation and marginal behavi
Biological/vaccine
Procedure/surgery

Sponsors

Faculdade de Odontologia de Araçatuba da Universidade Estadual Paulista "Júlio de Mesquita Filho"
Lead Sponsor
Faculdade de Odontologia de Araçatuba da Universidade Estadual Paulista "Júlio de Mesquita Filho"
Collaborator

Eligibility

Age
No minimum to 0 Years

Inclusion criteria

Inclusion criteria: Healthy patients who needed ceramic lveneers in the region between teeth 15 to 25; with healthy teeth and in good condition of periodontal health attested by clinical and radiographic examination; with the need to close diastemas; elimination of black spaces; corrections of shape and dental contour with aesthetic and / or functional justification attested by diagnostic waxing.

Exclusion criteria

Exclusion criteria: Periodontal disease active at the time of screening; structural damage to gingival architecture; pregnancy; diabetes mellitus; autoimmune diseases; other uncontrolled systemic changes with a damaging effect on gingival tissues; continuous medication users; presence of hormonal or vitamin deficiency; patients with a history of recent use of anti-inflammatories or antibiotics.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Evaluate the behavior of periodontal tissue by analyzing the amount of biomarkers and the volume of Gingival Crevicular Fluid (GCF) with additional verification of the adaptation and marginal behavior of the restoration, in teeth restored with 0.2mm thick thin ceramic veneers on the cervical edge, cemented over teeth without wear on the cervical portion and presenting a cervical border positioned inside the gingival sulcus. 73 maxillary teeth will be treated with ceramic laminates in monolithic lithium disilicate. For all elements, the GCF will be collected prior to cementation (baseline) and at the time of the study (t0- 7 days, t1 - 15 days, t2 - 30, t3 - 60 days, t4 180 days and t5 365 days), where the volume of GCF will be calculated and the biomarkers quantified: TNF-a, MMP-8, IL-1B, TGF-B and IL-6 by ELISA. The neighboring or antagonist tooth will be used as a control. The null hypotheses are that: The levels of biomarkers will not be altered after the installation of ceramic laminates and that The overlapping of the installed part will not be harmful to the periodontal tissue in the long term.;Found outcome: No significant statistical differences in (Gingival Crevicular Fluid) GCF volume were noticed over time or between control and restored groups. TNF-a decreased significantly in restored group at 7, 15, 30, 60, 180 and 365 days. The both groups showed significant statistical differences in the baseline time in comparison to 365 days. MMP-8 showed significant statistical differences between restored group in the baseline time in comparison to the same group at 30 and 60 days and in comparison, to control group at 15, 30 and 60 days. IL-1B increased significantly in restored group at 365 days in comparison to both groups at baseline, 7, 15, 30, 60 and 180 days. TGF-B increased significantly in restored group from baseline to 15 days and decreased significantly at 180 and 365 days. IL-6 showed significant statistical differences between re

Secondary

MeasureTime frame
Expected outcome 2: Replicas of the cervical region will be obtained in epoxy resin, in 7 days (t0) and 180 days (t4) to check the marginal adaptation in a scanning electron microscope. The clinical evaluation was performed according to the modified USPHS criteria at the time of the study and with 1 year of follow-up (t5). It is expected that there will be no bubbles, cracks and discontinuity points in the cementation line, without prejudice to the adaptation of the restoration to the tooth.;Found outcome 2: The qualitative evaluation of the facial axial contour showed a continuing finish line, like a knife-edge finish line, similar to a tooth without restoration. There was no noticed discontinuity in the cementation line of the ceramic veneers, neither alteration in the cervical edge. All elements obtained alpha concept for marginal adaptation.

Countries

Brazil

Contacts

Public ContactEduardo Rocha

Faculdade de Odontologia de Araçatuba da Universidade Estadual Paulista "Júlio de Mesquita Filho"

1rocha.eduardo@gmail.com+551836363250

Outcome results

None listed

Source: REBEC (via WHO ICTRP)