Evaluation of the Aesthetic Outcomes of the Single Crowns Supported by Tissue Level Implants

• Conditions: Poor Aesthetics of Existing Restoration
• Interventions: Procedure: single crowns supported by implants

• Registration Number: NCT02061930
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2014-02
• Study Start: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-13
• Last Update Posted: 2014-02-13
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single crowns supported by implants	single crowns supported by implants	single crowns supported by implants placed in the anterior maxilla region, periodontally healthy

Primary Outcome Measures

Name	Time	Method
aesthetic scores	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

Name	Time	Method
Modified plaque index (mPLI)	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).
marginal bone resorption	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)	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)	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.

Trial Locations

Locations (1)

Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital; 🇨🇳 Shanghai, Shanghai, China