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

Poor Aesthetics of Existing Restoration Clinical Trial

— PES/WES  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02061930
• Other study ID #: Shanghai9
• Status: Not yet recruiting
• Phase: N/A
• First received: February 7, 2014
• Last updated: February 11, 2014
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: February 2014
• Source: Shanghai 9th People's Hospital
• Contact: Xu Zhao, phd
• Phone: 13331169917
• Email: pig3333[@]foxmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Poor Aesthetics of Existing Restoration

Intervention

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

Locations

Country	Name	City	State
China	Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Belser U, Buser D, Higginbottom F. Consensus statements and recommended clinical procedures regarding esthetics in implant dentistry. Int J Oral Maxillofac Implants. 2004;19 Suppl:73-4. Review. — View Citation

Belser UC, Grütter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435 . — View Citation

Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24. — View Citation

Cosyn J, Eghbali A, De Bruyn H, Collys K, Cleymaet R, De Rouck T. Immediate single-tooth implants in the anterior maxilla: 3-year results of a case series on hard and soft tissue response and aesthetics. J Clin Periodontol. 2011 Aug;38(8):746-53. doi: 10.1111/j.1600-051X.2011.01748.x. — View Citation

Cosyn J, Eghbali A, De Bruyn H, Dierens M, De Rouck T. Single implant treatment in healing versus healed sites of the anterior maxilla: an aesthetic evaluation. Clin Implant Dent Relat Res. 2012 Aug;14(4):517-26. doi: 10.1111/j.1708-8208.2010.00300.x. Epub 2010 Jul 17. — View Citation

Dierens M, de Bruecker E, Vandeweghe S, Kisch J, de Bruyn H, Cosyn J. Alterations in soft tissue levels and aesthetics over a 16-22 year period following single implant treatment in periodontally-healthy patients: a retrospective case series. J Clin Perio — View Citation

Fürhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. — View Citation

Gallucci GO, Grütter L, Nedir R, Bischof M, Belser UC. Esthetic outcomes with porcelain-fused-to-ceramic and all-ceramic single-implant crowns: a randomized clinical trial. Clin Oral Implants Res. 2011 Jan;22(1):62-9. doi: 10.1111/j.1600-0501.2010.01997.x — View Citation

Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9. — View Citation

Henriksson K, Jemt T. Measurements of soft tissue volume in association with single-implant restorations: a 1-year comparative study after abutment connection surgery. Clin Implant Dent Relat Res. 2004;6(4):181-9. — View Citation

Lai HC, Zhang ZY, Wang F, Zhuang LF, Liu X, Pu YP. Evaluation of soft-tissue alteration around implant-supported single-tooth restoration in the anterior maxilla: the pink esthetic score. Clin Oral Implants Res. 2008 Jun;19(6):560-4. doi: 10.1111/j.1600-0 — View Citation

Meijer HJ, Stellingsma K, Meijndert L, Raghoebar GM. A new index for rating aesthetics of implant-supported single crowns and adjacent soft tissues--the Implant Crown Aesthetic Index. Clin Oral Implants Res. 2005 Dec;16(6):645-9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aesthetic scores	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	Yes
Primary	aesthetic scores	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	Yes
Primary	aesthetic scores	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	Yes
Secondary	Modified plaque index (mPLI)	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	Yes
Secondary	marginal bone resorption	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	Yes
Secondary	Modified sulcus bleeding index (mSBI)	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	Yes
Secondary	probing depth (PD)	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	Yes