Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Gingival Recession Clinical Trial

Official title:

Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276586
• Other study ID #: 2737P
• 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

Related Conditions & MeSH terms

• Gingival Bleeding
• Gingival Disease
• Gingival Diseases
• Gingival Hemorrhage
• Gingival Recession
• Periodontal Diseases

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