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Clinical Trials/NCT02276586
NCT02276586
Completed
Not Applicable

Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

University of Padova, School of Dental Medicine1 site in 1 country58 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
University of Padova, School of Dental Medicine
Enrollment
58
Locations
1
Primary Endpoint
Periodontal Probing Depth (PPD)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Padova, School of Dental Medicine
Responsible Party
Principal Investigator
Principal Investigator

Eriberto Bressan

Chairman, Department of Periodontology

University of Padova, School of Dental Medicine

Eligibility Criteria

Inclusion Criteria

  • The patient inclusion criteria were as follows:
  • dentate patients treatment planned for single unit restorations in the esthetic zone (from 1st premolar forward)
  • periodontal probing depth prior to tooth preparation ≤4mm, with no bleeding on probing and no plaque
  • \>30 years of age
  • full mouth plaque score (FMPS) and full mouth bleeding scores (FMBS) \<20% at study baseline
  • eventual loss of attachment limited only to areas different from the sites included in the study.
  • The patient exclusion criteria were as follows:
  • patient with medical history in which any dental intervention would be contraindicated
  • any local or systemic disease, condition or medication that might compromise healing and affect the periodontium
  • dental caries or periodontal disease in the remaining teeth

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Plaque Index (PI)

Time Frame: Change from Baseline Plaque Index at 12 months post intervention

Plaque Index (PI), according to Silness \& Loe

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

Study Sites (1)

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