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Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

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ClinicalTrials.gov Identifier: NCT02276586
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Eriberto Bressan, University of Padova, School of Dental Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gingival Recession Gingival Disease Gingival Bleeding Procedure: Horizontal Tooth preparation Procedure: Vertical Tooth preparation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design
Study Start Date : January 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
Horizontal Tooth preparation
 Procedure: Horizontal Tooth preparation
Round parallel chamfer diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)
Experimental: Group 2
Vertical tooth preparation
 Procedure: Vertical Tooth preparation
Long flame diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)


Outcome Measures
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Primary Outcome Measures :
  1. Plaque Index (PI) [ Time Frame: Change from Baseline Plaque Index at 12 months post intervention ]
    Plaque Index (PI), according to Silness & Loe

  2. 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.

  3. Gingival Index (GI) [ Time Frame: Change from Baseline Gingival Index (GI) at 12 months post intervention ]
    Gingival Index (GI), according to Silness & Loe

  4. 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)

  5. Gingival recession (GR) [ Time Frame: Change from Baseline Gingival recession (GR) at 12 months post intervention ]
    Gingival margin position related to the crown margin


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The patient inclusion criteria were as follows:

  1. dentate patients treatment planned for single unit restorations in the esthetic zone (from 1st premolar forward)
  2. periodontal probing depth prior to tooth preparation ≤4mm, with no bleeding on probing and no plaque
  3. >30 years of age
  4. full mouth plaque score (FMPS) and full mouth bleeding scores (FMBS) <20% at study baseline
  5. eventual loss of attachment limited only to areas different from the sites included in the study.

The patient exclusion criteria were as follows:

  1. patient with medical history in which any dental intervention would be contraindicated
  2. any local or systemic disease, condition or medication that might compromise healing and affect the periodontium
  3. dental caries or periodontal disease in the remaining teeth
  4. inability or unwillingness to return for follow-up visit.

Exlusion Criteria:

  1. patients with systemic diseases (such as heart, coagulation, and leukocyte diseases or metabolic disorders)
  2. history of radiation therapy in the head and neck region within 12 months prior to surgical phase
  3. current treatment with steroids
  4. neurological or psychiatric condition that could interfere with good oral hygiene
  5. immunocompromised status, including infection with human immunodeficiency virus
  6. smoking habit (more than 10 cigarettes/day)
  7. drug or alcohol abuse
  8. inadequate compliance
  9. patients who received bone regeneration procedure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276586


Locations
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Italy
University of Padova
Padova, PD, Italy, 35122
Sponsors and Collaborators
University of Padova, School of Dental Medicine
More Information
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Responsible Party: Eriberto Bressan, Chairman, Department of Periodontology, University of Padova, School of Dental Medicine
ClinicalTrials.gov Identifier: NCT02276586    
Other Study ID Numbers: 2737P
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Gingival Hemorrhage
Hemorrhage
Pathologic Processes
 Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Oral Hemorrhage