Evaluation of the Aesthetic Outcomes of the Single Crowns Supported by Tissue Level Implants (PES/WES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
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|
|Estimated Enrollment :||90 participants|
|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|
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
- 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
- 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.
- 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
- 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
- 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.
- 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)
- 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.
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
|Contact: Xu Zhao, firstname.lastname@example.org|
|Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital|
|Shanghai, Shanghai, China, 200011|
|Contact: HongChang Lai, DDS 86-021-23271699-5299 email@example.com|
|Principal Investigator: Hongchang Lai, DDS|
|Sub-Investigator: Xu Zhao, phd|
|Sub-Investigator: Yingxin Gu, Phd|
|Sub-Investigator: Shichong Qiao, Phd|
|Study Director:||Hongchang Lai, DDS||Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University|