Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

NCT ID: NCT02276586

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

Horizontal Tooth preparation

Group Type: ACTIVE_COMPARATOR

Horizontal Tooth preparation

Intervention Type: PROCEDURE

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

Group 2

Vertical tooth preparation

Group Type: EXPERIMENTAL

Vertical Tooth preparation

Intervention Type: PROCEDURE

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

Interventions

Horizontal Tooth preparation

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

Intervention Type: PROCEDURE

Vertical Tooth preparation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova, School of Dental Medicine

OTHER

Sponsor Role: lead

Responsible Party

Eriberto Bressan

Chairman, Department of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Padova

Padua, PD, Italy

Countries

Italy

Other Identifiers

2737P

Identifier Type: -

Identifier Source: org_study_id