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Completed

NCT Number: NCT02276586

Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

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.

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Key information

Conditions

Gingival Recession Gingival Bleeding Gingival Disease Gingival Diseases Gingival Hemorrhage Hemorrhage Mouth Diseases Oral Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Padova

Padova, PD, 35122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • inability or unwillingness to return for follow-up visit.

Exlusion Criteria:

  • patients with systemic diseases (such as heart, coagulation, and leukocyte diseases or metabolic disorders)
  • history of radiation therapy in the head and neck region within 12 months prior to surgical phase
  • current treatment with steroids
  • neurological or psychiatric condition that could interfere with good oral hygiene
  • immunocompromised status, including infection with human immunodeficiency virus
  • smoking habit (more than 10 cigarettes/day)
  • drug or alcohol abuse
  • inadequate compliance
  • patients who received bone regeneration procedure

Treatment and study plan

Horizontal Tooth preparation

Procedure

Round parallel chamfer diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)

Vertical Tooth preparation

Procedure

Long flame diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Padova, School of Dental Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2014
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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