Evaluation of the Aesthetic Outcomes of the Single Crowns Supported by Tissue Level Implants (PES/WES)

February 11, 2014 updated by: Hongchang Lai, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Evaluation of the Soft Tissue Stability Around Single Crowns Supported by Tissue Level Implants Placed in Non-augmented Healed Sites in the Anterior Maxilla: a Retrospective Study

The aim of this study is to review the long-term soft tissue stability and the long-term esthetic results of single crowns supported by tissue level implants placed in non-augmented healed sites.

The hypothesis of the present study is that tissue level implants can achieve ideal esthetic outcomes in non-augmented healed sites.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Both successful implant-supported restorations and the peri-implant soft and hard tissues are vital determinants which may affect the short- and long-term aesthetic outcomes.

For this reason, the pink aesthetic score (PES) was introduced for the evaluation of peri-implant soft tissues by Fürhauser in 2005 and modified by Belser as PES/WES in 2009.

So far, a series of clinical studies have confirmed the suitability of PES/WES and PES index for the objective outcome assessment of the aesthetic dimension of anterior single-tooth implants.

However, to our knowledge, studies with long term data of the aesthetic outcome evaluation in non-augmented healed sites of the anterior maxilla are still rare, for most of the papers published recently mainly focused on immediate implant placement after tooth extraction with only 1-5 years following up.

In our previous study, we have evaluated the alterations of soft tissue around implant-supported single crowns in the anterior maxilla with original standard PES at the time of crown placement and 6 months post-loading .We have found that the aesthetic outcome of soft tissue around the single-tooth implant had improved significantly at follow-up compared with baseline according to PES assessment. However, the follow up time of the previous study was short (6-8 months), long time follow up is necessary to confirm the previous hypothesis and observations.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Have at least one implant-supported single crown in the anterior maxilla region (13-23) with Straumann (Institute Straumann AG, Waldenburg, Switzerland) tissue level implants placed between December 2005 and October 2008.

Description

Inclusion Criteria:

  • Have had the tooth extraction at least 3 months before implant surgery.
  • Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery.
  • Did not receive restorative treatment of the adjacent teeth.
  • Underwent conventional healing and loading protocol after implant surgery.

  • Have both neighboring teeth and corresponding teeth in the mandible.

    ----For additional, the patients should have

  • Photographs of the anterior teeth, the photos should have been taken at right after crown placement and at the 6-10 months recall visit.
  • Radiographs of the implant-supported single crowns, the radiographs should have been taken at right after crown placement.

Exclusion Criteria:

  • Patients who don't fulfill the inclusion criteria
  • Patients who refused to join the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single crowns supported by implants
single crowns supported by implants placed in the anterior maxilla region, periodontally healthy
Procedure: single crowns supported by implants
The implant placement procedures were planned based on clinical and radiographic evaluation. During the surgeries, the mid-crestal incision and intra-crevicular incision were made following local articaine infiltration anesthesia. No releasing incisions were made. After full-thickness flaps were elevated labially and lingually to expose the alveolar ridge, the implants were placed according to the standard surgical procedures defined by the manufacturer. After a healing time of 10-16 weeks, implant-level impressions were taken. The porcelain (Ivoclar-Vivadent AG, Schaan, Lichtenstein) fused to noble metal crowns were fabricated. Abutment screws were torqued to 15 Ncm. Crowns were cemented with HY-bond Glassionomer Cement
Other Names:
  • Straumann dental implants SLA sp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aesthetic scores
Time Frame: baseline

The photos were taken 1 hour after cementation of the crowns Digital camera will being used during the examinations (Nikon D70, Nikon Medical Objective circular flash; Nikon Corporation, Tokyo, Japan).

The evaluation will be based on the pictures of the prosthesis and soft tissue around the crown which supported by implant.

7 parameters will be assessed for PES :mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture.

5 parameters will be assessed for WES:general tooth form; outline and volume of the clinical crown; color; surface texture; and translucency and characterization.

For both PES and WES, the score of 2, 1, or 0 is assigned to each parameter by certain evaluation standard
baseline
aesthetic scores
Time Frame: 6-10 months after crown placement

The pictures were taken routinely during patients's revisit . The PES will be assessed via photographs, in order to evaluate the changes of the soft tissue around the crown.

WES will not be evaluated at this time point.
6-10 months after crown placement
aesthetic scores
Time Frame: 5-8 years after crown placement

The photos will be taken by the same digital camera (Nikon D70, Nikon Medical Objective circular flash; Nikon Corporation, Tokyo, Japan)

both PES and WES will be evaluated at this time point
5-8 years after crown placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified plaque index (mPLI)
Time Frame: 5-8 years after restoration

The mPLI will be recorded at four sites (mesial, distal, buccal and palatal) around each of the implant-supported single crowns by a periodontal probe (15 UNC/CP-11.5B Screening Color-Coded Probe

, Hu-Friedy).
5-8 years after restoration
marginal bone resorption
Time Frame: 5-8 years after restoration
As routine postoperative examination, peri-apical radiographs were taken for all the patients with the long-cone technique at the time when the crowns were cemented. And the latest radiographs will be taken at the time of the last revisit. All of the radiographic films were scanned at 600 dpi with a scanner and the marginal bone level will be assessed with image analysis software.The distance between implant shoulder and first visible bone-to-implant contact (BID) will be measured on the mesial and distal aspects. For each implant and each examination period, the values will be calculated as the average of the obtained mesial and distal values.
5-8 years after restoration
Modified sulcus bleeding index (mSBI)
Time Frame: 5-8 years after crown placement
mSBI will recorded at four sites (mesial, distal, buccal and palatal) around each of the implant-supported single crowns by a periodontal probe (15 UNC/CP-11.5B Screening Color-Coded Probe, Hu-Friedy)
5-8 years after crown placement
probing depth (PD)
Time Frame: 5-8 years after crown placement

The peri-implant probing depth was recorded by a periodontal probe (15 UNC/CP-11.5B Screening Color-Coded Probe

, Hu-Friedy) at the four sites too (Mesial, Distal, buccal, lingual). The recordings were made to the nearest millimeter.
5-8 years after crown placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • Study Director: Hongchang Lai, DDS, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Shanghai9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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