Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment

Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment. A Longitudinal Study

The aim of the present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the supracrestal tissue attachment.

Study Overview

• Status: Completed
• Conditions: Gingivitis

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • AOUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients coming to the Endodontic and Restorative department of Policlinico le Scotte- Siena, when eligible, were included in the study.

Description

Inclusion Criteria:

• an age range 18-70 years
• a good general health
• the ability to understand the phases of the trial and to stick to them for the whole length of the study
• the ability of will to release a written informed consent
• presence of a marginal cavity or a 2mm subgingival cavity
• presence of a cavity subgingival > 2mm

Exclusion Criteria:

• PPD>4mm
• patients affected by active periodontal disease
• patients smoking more than 10 cigarettes/pipes per day

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on Probing	bleeding from the gingival sulcus when probing	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic distance from the caries/margin of the restoration to the bone crest	LInear measurement between the most apical level of the restoration to the bone crest	12 months

Collaborators and Investigators

• Sponsor: University of Siena

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): June 29, 2019
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: biomarkers; cytokine; subgingival restorations; proximal restorations; GCF sampling
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: PR001