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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02276586
Other study ID # 2737P
Secondary ID
Status Completed
Phase N/A
First received October 9, 2014
Last updated October 23, 2014
Start date January 2013
Est. completion date September 2014

Study information

Verified date October 2014
Source University of Padova, School of Dental Medicine
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
Horizontal Tooth preparation
Round parallel chamfer diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)
Vertical Tooth preparation
Long flame diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)

Locations

Country Name City State
Italy University of Padova Padova PD

Sponsors (1)

Lead Sponsor Collaborator
University of Padova, School of Dental Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque Index (PI) Plaque Index (PI), according to Silness & Loe Change from Baseline Plaque Index at 12 months post intervention No
Primary 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 No
Primary Gingival Index (GI) Gingival Index (GI), according to Silness & Loe Change from Baseline Gingival Index (GI) at 12 months post intervention No
Primary 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 No
Primary Gingival recession (GR) Gingival margin position related to the crown margin Change from Baseline Gingival recession (GR) at 12 months post intervention No
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