Clinical trial NCT02061930: Evaluation of the Aesthetic Outcomes of the Single Crowns Supported by Tissue Level Implants
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poor Aesthetics of Existing Restoration
Keywords: single tooth
dental implant
aesthetics outcome
long term
soft tissue recession
pink esthetic score
white esthetic score
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: aesthetic scores
timeFrame: baseline
measure: aesthetic scores
timeFrame: 6-10 months after crown placement
measure: aesthetic scores
timeFrame: 5-8 years after crown placement
Secondary outcomes:
measure: Modified plaque index (mPLI)
timeFrame: 5-8 years after restoration
measure: marginal bone resorption
timeFrame: 5-8 years after restoration
measure: Modified sulcus bleeding index (mSBI)
timeFrame: 5-8 years after crown placement
measure: probing depth (PD)
timeFrame: 5-8 years after crown placement
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Hongchang Lai, DDS
role: STUDY_DIRECTOR
References:
citation: Furhauser 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. doi: 10.1111/j.1600-0501.2005.01193.x.
citation: 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. No abstract available.
citation: Belser UC, Grutter 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.
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.
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.
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. doi: 10.1111/j.1708-8208.2004.tb00034.x.
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.
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.
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.1600-0501.2008.01522.x.
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. doi: 10.1111/j.1600-0501.2005.01128.x.
citation: Gallucci GO, Grutter 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. Epub 2010 Sep 24.
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 Periodontol. 2013 Mar;40(3):311-8. doi: 10.1111/jcpe.12049. Epub 2013 Jan 9.