Aesthetic Outcomes of Single Tooth Implant-supported Restorations in the Anterior Maxilla With Either White Zirconia or Fluorescent White Zirconia Abutments

Aesthetic Outcomes of Single Tooth Implant-supported Restorations in the Anterior Maxilla With Either White Zirconia or Fluorescent White Zirconia Abutments: A Randomized Controlled Clinical Study.

This study aims to answer the question whether the use of a fluorescent layer over white zirconia abutments will improve the aesthetic outcomes of implant borne single-tooth restorations when compared to the use of non-layered white zirconia abutments. The study is designed as a parallel, single-centre and double blind clinical trial. Patients in need of a single tooth implant in the maxilla (from right second premolar to left second premolar, both included) with the presence of adjacent natural teeth will be randomly divided into two treatment groups: using white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) with immersion in fluorescent liquid (Zirkonzahn, South Tirol, Italy)(test group) or white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) without immersion in fluorescent liquid (control group). 1 and 12 months after crown placement, patients will be recalled and subjected to aesthetic, clinical, radiographic and patient centered outcomes.

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge in the Aesthetic Zone
• Intervention / Treatment: Other: Implant placement and prothesis made with different types of abutment

Detailed Description

Dental implants (Tapered internal implants; BioHorizons, Birmingham, EEUU) will be placed in healed residual ridges (minimum of 4 months after tooth extraction) following the manufacturer's recommendations. After connecting healing abutments, the flaps will be sutured around the abutments for non-submerged healing. A standard postoperative protocol will be followed (antibiotics, anti-inflammatory medication and topical application of 0.12% clorhexidine) and fixed or removable provisional restorations will be provided without immediate occlusal function.

After a 3-months of healing, subjects will be allocated to either test or control group. An abutment composed of white yttrium oxide stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) previously immersed in fluorescent liquid (Zirkonzahn, South Tirol, Italy) will be placed in the test group, whether in the control group the same abutment will be used but without fluorescent layer. The selected abutment is machined and designed for use with cemented restorations.

A single experienced restorative dentist using one dental laboratory will carry out all the prosthetic procedures. Single crowns full ceramic will be performed and cemented with RelyX™ Luting Cement.

The subjects will then be advised to comply with their regular dental hygiene and maintenance protocol and committed to return for one month and one-year examinations in order to register all the outcome variables of the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28023
    • Leticia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:- Systemically and periodontally healthy subjects,18 years of age with good plaque control (less than 25% PlI) or subjects with a healthy periodontium if selected from a periodontal maintenance program.

• The presence of a single tooth gap in the anterior maxilla (from tooth number 1.5-2.5) with the presence of natural adjacent dentition. A minimum 4 months healing was required if the tooth had been recently extracted.
• The presence of ≥ 2 mm of keratinized tissue in the alveolar ridge and enough bone availability to insert a Tapered internal implant (BioHorizons, Birmingham, EEUU) without the need of bone augmentation (minimum of 5.5 mm in width and 9 mm in height).
• The opposing dentition should be stable (without removable appliances) and subjects with bruxism were excluded.

Exclusion Criteria:

• In patients with a history of periodontitis, if periodontitis re-occurred (clinical attachment loss ≥ 2 mm), they will be excluded from the study and receive periodontal therapy.

  • During implant placement, the selected subject will be excluded if implants were not positioned in appropriate prosthetic guided positions. Implants needing any hard tissue augmentation will be excluded before the surgery, however if during the surgery any of this procedure is needed due to unforeseen, the patient will also be excluded from the study "a posteriori".
  • Pregnant women at any time of the study will be excluded.
  • Inadequate vestibular depth to place the Spectrophotometer device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: white yttria-stabilized zirconia abutment; white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) without immersion in fluorescent liquid	Other: Implant placement and prothesis made with different types of abutment; Dental implants (Tapered internal implants; BioHorizons, Birmingham, EEUU) will be placed in healed residual ridges (minimum of 4 months after tooth extraction). After connecting healing abutments, the flaps will be sutured around the abutments for non-submerged healing. An abutment composed of white yttrium oxide stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) previously immersed in fluorescent liquid (Zirkonzahn, South Tirol, Italy) will be placed in the test group, whether in the control group the same abutment will be used but without fluorescent layer. The selected abutment is machined and designed for use with cemented restorations. A single experienced restorative dentist using one dental laboratory carried out all the prosthetic procedures. Single crowns full ceramic will be performed and cemented with RelyX™ Luting Cement.
Experimental: fluorescence white yttria-stabilized zirconia abutment; white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) with immersion in fluorescent liquid	Other: Implant placement and prothesis made with different types of abutment; Dental implants (Tapered internal implants; BioHorizons, Birmingham, EEUU) will be placed in healed residual ridges (minimum of 4 months after tooth extraction). After connecting healing abutments, the flaps will be sutured around the abutments for non-submerged healing. An abutment composed of white yttrium oxide stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) previously immersed in fluorescent liquid (Zirkonzahn, South Tirol, Italy) will be placed in the test group, whether in the control group the same abutment will be used but without fluorescent layer. The selected abutment is machined and designed for use with cemented restorations. A single experienced restorative dentist using one dental laboratory carried out all the prosthetic procedures. Single crowns full ceramic will be performed and cemented with RelyX™ Luting Cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The spectrophotometric outcome ΔE is the primary outcome of this study	Spectrophotometry (Spectroshade, MTH, Niederhasli, Switzerland) will be used for the color evaluation of the buccal mucosa	1 month after prothesis restoration
The spectrophotometric outcome ΔE is the primary outcome of this study	Spectrophotometry (Spectroshade, MTH, Niederhasli, Switzerland) will be used for the color evaluation of the buccal mucosa	1 year after prothesis restoration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective aesthetic outcomes	The esthetic index for anterior maxillary implant-supported restorations (CEI) (Juodzbalys et al. 2010) has been selected as visual complex aesthetic index	1 month after prothesis restoration
Subjective aesthetic outcomes	The esthetic index for anterior maxillary implant-supported restorations (CEI) (Juodzbalys et al. 2010) has been selected as visual complex aesthetic index	1 year after prothesis restoration
Biological complications	Biological complications are considered where there is presence of bleeding on probing (BOP) (peri-implant mucositis) or when BOP is present together with peri-implant bone loss (peri-implantitis)(Lang & Berglund 2011).	1 month after prothesis restoration
Biological Complications	Biological complications are considered where there is presence of bleeding on probing (BOP) (peri-implant mucositis) or when BOP is present together with peri-implant bone loss (peri-implantitis)(Lang & Berglund 2011).	1 year after prothesis restoration
Technical complications	Technical complications will be considered as (1) major (requiring replacement of the restoration); such as, implant fracture, abutment tooth fracture, loss of supra-structures, (2) medium; such as abutment fracture, veneer or framework fractures, phonetic complications and (3) minor such as abutment and screw loosening, loss of retention, de-bonding, loss of screw hole sealing or veneer chipping (Lang & Zitzmann 2012).	1 month after final prothesis
Technical complications	Technical complications will be considered as (1) major (requiring replacement of the restoration); such as, implant fracture, abutment tooth fracture, loss of supra-structures, (2) medium; such as abutment fracture, veneer or framework fractures, phonetic complications and (3) minor such as abutment and screw loosening, loss of retention, de-bonding, loss of screw hole sealing or veneer chipping (Lang & Zitzmann 2012).	1 year after prothesis restoration
Clinical outcomes	the mesial and distal adjacent teeth were measured to the nearest 1 mm using a CPC-15 manual periodontal probe (Hu-Friedy, Leinmen, Germany) at 6 six sites per tooth for probing pocket depths (PPD).	Preoperatively
Clinical outcomes	Full mouth plaque index was recorded.	Preoperatively
Clinical outcomes	bleeding on probing was recorded.	Preoperatively
Clinical outcomes	The implant probing depth was measured to the nearest 1 mm using a CPC-15 manual periodontal probe (Hu-Friedy, Leinmen, Germany) at 6 six sites per tooth for probing pocket depths (PPD).	1 month after prothesis restoration
Clinical outcomes	The implant probing depth was measured to the nearest 1 mm using a CPC-15 manual periodontal probe (Hu-Friedy, Leinmen, Germany) at 6 six sites per tooth for probing pocket depths (PPD).	1 year after prothesis restoration
Clinical Outcomes	Full mouth plaque index were also be recorded.	1 month after final prothesis
Clinical Outcomes	Full mouth plaque index were also be recorded.	1 year after final prothesis
Clinical outcomes	mucosal recession at the implant (REC) was also recorded	1 month after prothesis restoration
Clinical outcomes	mucosal recession at the implant (REC) was also recorded	1 year after prothesis restoration
Clinical outcomes	mucosal recession in the adjacent teeth (REC) was also recorded	1 month after prothesis restoration
Clinical outcomes	mucosal recession in the adjacent teeth (REC) was also recorded	1 year after prothesis restoration
Radiographic outcomes	Standardized intra-oral radiographs were taken using a long-cone paralleling technique and an individualized tooth positioner made of auto-polymerising silicon key (Dentsply Rinn; Elgin, United States). The radiographs were taken immediately after crown placement and at the 12 months follow up. The radiographs were scanned and calibrated using the implant diameter as the fixed reference and the following linear measurements were carried out using image analysis software (NIS-elements software; Nikon, Tokyo, Japan).- Vertical distance (parallel to the implant long axis) from the contact point to the bone crest at mesial and distal sides.; Vertical distance from the implant shoulder (placed 1 mm supracrestally) to the most coronal bone in contact with the implant at mesial and distal sites.; Horizontal distance from the implant shoulder to the adjacent teeth at mesial and distal sides.	1 year after prothesis restoration
Patient centred outcomes	The participating subjects were asked to fill in a written questionnaire for evaluating their satisfaction with regards to the aesthetic appearance, the phonetic ability and their overall satisfaction with the treatment (Pjetursson et al. 2005).	1 month after prothesis restoration
Patient centred outcomes	The participating subjects were asked to fill in a written questionnaire for evaluating their satisfaction with regards to the aesthetic appearance, the phonetic ability and their overall satisfaction with the treatment (Pjetursson et al. 2005).	1 year after prothesis restoration

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Publications and helpful links

General Publications

• Juodzbalys G, Wang HL. Esthetic index for anterior maxillary implant-supported restorations. J Periodontol. 2010 Jan;81(1):34-42. doi: 10.1902/jop.2009.090385.
• 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.
• 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.
• Chang M, Odman PA, Wennstrom JL, Andersson B. Esthetic outcome of implant-supported single-tooth replacements assessed by the patient and by prosthodontists. Int J Prosthodont. 1999 Jul-Aug;12(4):335-41.
• 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.
• Lang NP, Zitzmann NU; Working Group 3 of the VIII European Workshop on Periodontology. Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes. J Clin Periodontol. 2012 Feb;39 Suppl 12:133-8. doi: 10.1111/j.1600-051X.2011.01842.x.
• Park SE, Da Silva JD, Weber HP, Ishikawa-Nagai S. Optical phenomenon of peri-implant soft tissue. Part I. Spectrophotometric assessment of natural tooth gingiva and peri-implant mucosa. Clin Oral Implants Res. 2007 Oct;18(5):569-74. doi: 10.1111/j.1600-0501.2007.01391.x. Epub 2007 Jul 26.
• Pjetursson BE, Zwahlen M, Lang NP. Quality of reporting of clinical studies to assess and compare performance of implant-supported restorations. J Clin Periodontol. 2012 Feb;39 Suppl 12:139-59. doi: 10.1111/j.1600-051X.2011.01828.x.
• Pjetursson BE, Karoussis I, Burgin W, Bragger U, Lang NP. Patients' satisfaction following implant therapy. A 10-year prospective cohort study. Clin Oral Implants Res. 2005 Apr;16(2):185-93. doi: 10.1111/j.1600-0501.2004.01094.x.
• Sailer I, Zembic A, Jung RE, Siegenthaler D, Holderegger C, Hammerle CH. Randomized controlled clinical trial of customized zirconia and titanium implant abutments for canine and posterior single-tooth implant reconstructions: preliminary results at 1 year of function. Clin Oral Implants Res. 2009 Mar;20(3):219-25. doi: 10.1111/j.1600-0501.2008.01636.x.
• Tymstra N, Raghoebar GM, Vissink A, Den Hartog L, Stellingsma K, Meijer HJ. Treatment outcome of two adjacent implant crowns with different implant platform designs in the aesthetic zone: a 1-year randomized clinical trial. J Clin Periodontol. 2011 Jan;38(1):74-85. doi: 10.1111/j.1600-051X.2010.01638.x. Epub 2010 Nov 10.
• Zembic A, Bosch A, Jung RE, Hammerle CH, Sailer I. Five-year results of a randomized controlled clinical trial comparing zirconia and titanium abutments supporting single-implant crowns in canine and posterior regions. Clin Oral Implants Res. 2013 Apr;24(4):384-90. doi: 10.1111/clr.12044. Epub 2012 Oct 2.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): January 22, 2019
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 23, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 23, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: implants AND periodontology AND color OR zirconia AND periimplant mucosa color OR spectrophotometer AND periimplant color
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: EC14/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No