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

NCT02061930 | Unknown

• 1 other identifier: Shanghai9
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Aesthetics of Existing Restoration

Keywords

single tooth; dental implant; aesthetics outcome; long term; soft tissue recession; pink esthetic score; white esthetic score

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (4)

• Modified plaque index (mPLI)

  5-8 years after restoration

• marginal bone resorption

  5-8 years after restoration

• Modified sulcus bleeding index (mSBI)

  5-8 years after crown placement

• probing depth (PD)

  5-8 years after crown placement

Study Arms (1)

single crowns supported by implants

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

Procedure: single crowns supported by implants

Interventions

single crowns supported by implants PROCEDURE

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

Also known as: Straumann dental implants SLA sp

single crowns supported by implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who refused to join the study

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (12)

• 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.

  PMID: 16307569 BACKGROUND

• 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.

  PMID: 15635947 BACKGROUND

• 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.

  PMID: 19228100 BACKGROUND

• 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.

  PMID: 23347346 BACKGROUND

• 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.

  PMID: 15839587 BACKGROUND

• 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.

  PMID: 15841578 BACKGROUND

• 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.

  PMID: 21752044 BACKGROUND

• 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.

  PMID: 20662859 BACKGROUND

• 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.

  PMID: 18474062 RESULT

• 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.

  PMID: 16307570 RESULT

• 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.

  PMID: 21158931 RESULT

• 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.

  PMID: 23297745 RESULT

Study Officials

• Hongchang Lai, DDS

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  STUDY DIRECTOR

Central Study Contacts

Xu Zhao, phd

CONTACT

13331169917; pig3333@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dept. Oral & Maxillofacial Implantology

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 13, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

CN (1)