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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299347
• Other study ID #: PR001
• Status: Completed
• Start date: November 29, 2018
• Est. completion date: March 3, 2020

Study information

• Verified date: March 2020
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 3, 2020
• Est. primary completion date: June 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on Probing	bleeding from the gingival sulcus when probing	12 months
Secondary	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