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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession; Gingival Bleeding; Gingival Disease
• Intervention / Treatment: Procedure: Horizontal Tooth preparation; Procedure: Vertical Tooth preparation

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PD
    • Padova, PD, Italy, 35122
      • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index (PI)	Plaque Index (PI), according to Silness & Loe	Change from Baseline Plaque Index at 12 months post intervention
Periodontal Probing Depth (PPD)	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.	Change from Baseline Periodontal Probing Depth (PPD) at 12 months post intervention
Gingival Index (GI)	Gingival Index (GI), according to Silness & Loe	Change from Baseline Gingival Index (GI) at 12 months post intervention
Bleeding on Probing (BOP)	Bleeding on Probing (BOP), according to Ainamo & Bay (presence or absence)	Change from Baseline Bleeding on Probing (BOP) at 12 months post intervention
Gingival recession (GR)	Gingival margin position related to the crown margin	Change from Baseline Gingival recession (GR) at 12 months post intervention

Collaborators and Investigators

• Sponsor: University of Padova, School of Dental Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Oral Hemorrhage; Gingival Recession; Gingival Diseases; Gingival Hemorrhage
• Other Study ID Numbers: 2737P