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

Primary Purpose

Edentulous Alveolar Ridge in the Aesthetic Zone

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Implant placement and prothesis made with different types of abutment

About this trial

This is an interventional treatment trial for Edentulous Alveolar Ridge in the Aesthetic Zone focused on measuring implants AND periodontology AND color OR zirconia AND periimplant mucosa color OR spectrophotometer AND periimplant color

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Leticia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

white yttria-stabilized zirconia abutment

fluorescence white yttria-stabilized zirconia abutment

Arm Description

white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) without immersion in fluorescent liquid

white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) with immersion in fluorescent liquid

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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).

Biological Complications

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).

Technical complications

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).

Clinical outcomes

Full mouth plaque index was recorded.

Clinical outcomes

bleeding on probing was recorded.

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).

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).

Clinical Outcomes

Full mouth plaque index were also be recorded.

Clinical Outcomes

Full mouth plaque index were also be recorded.

Clinical outcomes

mucosal recession at the implant (REC) was also recorded

Clinical outcomes

mucosal recession at the implant (REC) was also recorded

Clinical outcomes

mucosal recession in the adjacent teeth (REC) was also recorded

Clinical outcomes

mucosal recession in the adjacent teeth (REC) was also recorded

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.

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).

Patient centred outcomes

Full Information

NCT ID

NCT05475249

First Posted

June 27, 2022

Last Updated

July 23, 2022

Sponsor

Universidad Complutense de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT05475249

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

January 8, 2018 (Actual)

Primary Completion Date

January 22, 2019 (Actual)

Study Completion Date

November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous Alveolar Ridge in the Aesthetic Zone

Keywords

implants AND periodontology AND color OR zirconia AND periimplant mucosa color OR spectrophotometer AND periimplant color

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

The study is designed as double blind, as patient and the clinical examiner (LS) will not have information at any time of which type of abutment is placing, this would be possible due to the identical aspect of both type of abutments. The randomization will be done by the other examiner (AC), that will inform the laboratory.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

white yttria-stabilized zirconia abutment

Arm Type

Placebo Comparator

Arm Description

white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) without immersion in fluorescent liquid

Arm Title

fluorescence white yttria-stabilized zirconia abutment

Arm Type

Experimental

Arm Description

white yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) with immersion in fluorescent liquid

Intervention Type

Other

Intervention Name(s)

Implant placement and prothesis made with different types of abutment

Intervention Description

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.

Primary Outcome Measure Information:

Title

The spectrophotometric outcome ΔE is the primary outcome of this study

Description

Spectrophotometry (Spectroshade, MTH, Niederhasli, Switzerland) will be used for the color evaluation of the buccal mucosa

Time Frame

1 month after prothesis restoration

Title

The spectrophotometric outcome ΔE is the primary outcome of this study

Description

Spectrophotometry (Spectroshade, MTH, Niederhasli, Switzerland) will be used for the color evaluation of the buccal mucosa

Time Frame

1 year after prothesis restoration

Secondary Outcome Measure Information:

Title

Subjective aesthetic outcomes

Description

The esthetic index for anterior maxillary implant-supported restorations (CEI) (Juodzbalys et al. 2010) has been selected as visual complex aesthetic index

Time Frame

1 month after prothesis restoration

Title

Subjective aesthetic outcomes

Description

The esthetic index for anterior maxillary implant-supported restorations (CEI) (Juodzbalys et al. 2010) has been selected as visual complex aesthetic index

Time Frame

1 year after prothesis restoration

Title

Biological complications

Description

Time Frame

1 month after prothesis restoration

Title

Biological Complications

Description

Time Frame

1 year after prothesis restoration

Title

Technical complications

Description

Time Frame

1 month after final prothesis

Title

Technical complications

Description

Time Frame

1 year after prothesis restoration

Title

Clinical outcomes

Description

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).

Time Frame

Preoperatively

Title

Clinical outcomes

Description

Full mouth plaque index was recorded.

Time Frame

Preoperatively

Title

Clinical outcomes

Description

bleeding on probing was recorded.

Time Frame

Preoperatively

Title

Clinical outcomes

Description

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).

Time Frame

1 month after prothesis restoration

Title

Clinical outcomes

Description

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).

Time Frame

1 year after prothesis restoration

Title

Clinical Outcomes

Description

Full mouth plaque index were also be recorded.

Time Frame

1 month after final prothesis

Title

Clinical Outcomes

Description

Full mouth plaque index were also be recorded.

Time Frame

1 year after final prothesis

Title

Clinical outcomes

Description

mucosal recession at the implant (REC) was also recorded

Time Frame

1 month after prothesis restoration

Title

Clinical outcomes

Description

mucosal recession at the implant (REC) was also recorded

Time Frame

1 year after prothesis restoration

Title

Clinical outcomes

Description

mucosal recession in the adjacent teeth (REC) was also recorded

Time Frame

1 month after prothesis restoration

Title

Clinical outcomes

Description

mucosal recession in the adjacent teeth (REC) was also recorded

Time Frame

1 year after prothesis restoration

Title

Radiographic outcomes

Description

Time Frame

1 year after prothesis restoration

Title

Patient centred outcomes

Description

Time Frame

1 month after prothesis restoration

Title

Patient centred outcomes

Description

Time Frame

1 year after prothesis restoration

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Leticia

City

Madrid

ZIP/Postal Code

28023

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19228100

Citation

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Results Reference

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PubMed Identifier

10635203

Citation

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.

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23297745

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.

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PubMed Identifier

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Citation

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Citation

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.

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Citation

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

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