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

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ClinicalTrials.gov Identifier: NCT02061930
Recruitment Status : Unknown
Verified February 2014 by Hongchang Lai, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Hongchang Lai, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary:

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.


Condition or disease Intervention/treatment
Poor Aesthetics of Existing Restoration Procedure: single crowns supported by implants

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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : February 2014
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

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 Name: Straumann dental implants SLA sp




Primary Outcome Measures :
  1. 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


  2. 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.


  3. 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



Secondary Outcome Measures :
  1. 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).


  2. 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.

  3. 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)

  4. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061930


Contacts
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Contact: Xu Zhao, phd 13331169917 pig3333@foxmail.com

Locations
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China, Shanghai
Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital Not yet recruiting
Shanghai, Shanghai, China, 200011
Contact: HongChang Lai, DDS    86-021-23271699-5299    lhc9@hotmail.com   
Principal Investigator: Hongchang Lai, DDS         
Sub-Investigator: Xu Zhao, phd         
Sub-Investigator: Yingxin Gu, Phd         
Sub-Investigator: Shichong Qiao, Phd         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Director: Hongchang Lai, DDS Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications of Results:
Other Publications:

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Responsible Party: Hongchang Lai, Dept. Oral & Maxillofacial Implantology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02061930     History of Changes
Other Study ID Numbers: Shanghai9
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Hongchang Lai, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
single tooth
dental implant
aesthetics outcome
long term
soft tissue recession
pink esthetic score
white esthetic score