Clinical Trial: Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Brief Summary:

Background: The actual literature is consistent in considering potential negative effects of sub-gingival prosthetic margins on the periodontal health, but no research has focused the attention on the type of prosthetic margin designs. Hence, the aim of the present study is to evaluate if a horizontal finishing line (deep chamfer preparation) may have a different influence on periodontal soft tissue in comparison with a vertical finishing line (feather edge preparation).

Methods: A prospective randomized controlled double blind clinical trial with one single operator and three experienced examiners was performed. One hundred and six crowns were prepared with horizontal tooth preparation while ninety-four with vertical tooth preparation. All the margins were positioned within the periodontal sulcus, at 0.5mm sub-gingivally and all the all-ceramic restorations were cemented with resin cement. Periodontal Probing Depth (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival Bleeding on Probing (BOP) were recorded prior to tooth preparation and twelve month after crown cementation. Also, at 12 months follow-up, the gingival margin position was related to the crown margin position.


Detailed Summary:
Sponsor: University of Padova, School of Dental Medicine

Current Primary Outcome:

  • Plaque Index (PI) [ Time Frame: Change from Baseline Plaque Index at 12 months post intervention ]
    Plaque Index (PI), according to Silness & Loe
  • Periodontal Probing Depth (PPD) [ Time Frame: Change from Baseline Periodontal Probing Depth (PPD) at 12 months post intervention ]
    Periodontal Probing Depth (PPD) measured at three different facial sites (mesial, facial, distal), with the utilization of a periodontal probe (UNC periodontal probe, Hu-Friedy, Chicago, IL) recording the measurements to the nearest millimeter.
  • Gingival Index (GI) [ Time Frame: Change from Baseline Gingival Index (GI) at 12 months post intervention ]
    Gingival Index (GI), according to Silness & Loe
  • Bleeding on Probing (BOP) [ Time Frame: Change from Baseline Bleeding on Probing (BOP) at 12 months post intervention ]
    Bleeding on Probing (BOP), according to Ainamo & Bay (presence or absence)
  • Gingival recession (GR) [ Time Frame: Change from Baseline Gingival recession (GR) at 12 months post intervention ]
    Gingival margin position related to the crown margin


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Padova, School of Dental Medicine

Dates:
Date Received: October 9, 2014
Date Started: January 2013
Date Completion:
Last Updated: October 23, 2014
Last Verified: October 2014