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Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Primary Purpose

Gingival Recession, Gingival Disease, Gingival Bleeding

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Horizontal Tooth preparation

Vertical Tooth preparation

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Horizontal Tooth preparation

Vertical tooth preparation

Outcomes

Primary Outcome Measures

Plaque Index (PI)

Plaque Index (PI), according to Silness & Loe

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.

Gingival Index (GI)

Gingival Index (GI), according to Silness & Loe

Bleeding on Probing (BOP)

Bleeding on Probing (BOP), according to Ainamo & Bay (presence or absence)

Gingival recession (GR)

Gingival margin position related to the crown margin

Secondary Outcome Measures

Full Information

NCT ID

NCT02276586

First Posted

October 9, 2014

Last Updated

October 23, 2014

Sponsor

University of Padova, School of Dental Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02276586

Brief Title

Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Official Title

Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Padova, School of Dental Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession, Gingival Disease, Gingival Bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

Horizontal Tooth preparation

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Vertical tooth preparation

Intervention Type

Procedure

Intervention Name(s)

Horizontal Tooth preparation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Vertical Tooth preparation

Intervention Description

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

Primary Outcome Measure Information:

Title

Plaque Index (PI)

Description

Plaque Index (PI), according to Silness & Loe

Time Frame

Change from Baseline Plaque Index at 12 months post intervention

Title

Periodontal Probing Depth (PPD)

Description

Time Frame

Change from Baseline Periodontal Probing Depth (PPD) at 12 months post intervention

Title

Gingival Index (GI)

Description

Gingival Index (GI), according to Silness & Loe

Time Frame

Change from Baseline Gingival Index (GI) at 12 months post intervention

Title

Bleeding on Probing (BOP)

Description

Bleeding on Probing (BOP), according to Ainamo & Bay (presence or absence)

Time Frame

Change from Baseline Bleeding on Probing (BOP) at 12 months post intervention

Title

Gingival recession (GR)

Description

Gingival margin position related to the crown margin

Time Frame

Change from Baseline Gingival recession (GR) at 12 months post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Padova

City

Padova

State/Province

ZIP/Postal Code

35122

Country

Italy

12. IPD Sharing Statement

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Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

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