Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

NCT02276586 | Completed DMC

• 1 other identifier: 2737P
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession; Gingival Disease; Gingival Bleeding

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Horizontal Tooth preparation

Procedure: Horizontal Tooth preparation

Group 2

EXPERIMENTAL

Vertical tooth preparation

Procedure: Vertical Tooth preparation

Interventions

Horizontal Tooth preparation PROCEDURE

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

Group 1

Vertical Tooth preparation PROCEDURE

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

Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova, School of Dental Medicine: lead

Study Sites (1)

University of Padova

Padua, PD, 35122, Italy

Location

MeSH Terms

Conditions

Gingival Recession; Gingival Diseases; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Periodontology

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 28, 2014
• Study Start: January 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

IT (1)