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Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02276586
Enrollment
58
Registered
2014-10-28
Start date
2013-01-31
Completion date
2014-09-30
Last updated
2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Bleeding, Gingival Disease, Gingival Recession

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.

Interventions

PROCEDUREHorizontal Tooth preparation

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

PROCEDUREVertical Tooth preparation

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

Sponsors

University of Padova, School of Dental Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plaque Index (PI)Change from Baseline Plaque Index at 12 months post interventionPlaque Index (PI), according to Silness & Loe
Periodontal Probing Depth (PPD)Change from Baseline Periodontal Probing Depth (PPD) at 12 months post interventionPeriodontal 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)Change from Baseline Gingival Index (GI) at 12 months post interventionGingival Index (GI), according to Silness & Loe
Bleeding on Probing (BOP)Change from Baseline Bleeding on Probing (BOP) at 12 months post interventionBleeding on Probing (BOP), according to Ainamo & Bay (presence or absence)
Gingival recession (GR)Change from Baseline Gingival recession (GR) at 12 months post interventionGingival margin position related to the crown margin

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026