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Edentulous Alveolar Ridge in the Aesthetic ZoneNCT05475249

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

A study testing Implant placement and prothesis made with different types of abutment in people with Edentulous Alveolar Ridge in the Aesthetic Zone, run by Universidad Complutense de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Implant placement and prothesis made with different types of abutment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSpain
Study dates
8 Jan 2018to 20 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Leticia

    Madrid, 28023

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
Implant placement and prothesis made with different types of abutment
Keywords
implants AND periodontology AND color OR zirconia AND periimplant mucosa color OR spectrophotometer AND periimplant color

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implant placement and prothesis made with different types of abutmentOther

    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.

Study groups in NCT05475249
Study groupRoleWhat they receive
white yttria-stabilized zirconia abutmentPlacebo comparatorwhite yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) without immersion in fluorescent liquid
Receives: Other: Implant placement and prothesis made with different types of abutment
fluorescence white yttria-stabilized zirconia abutmentExperimentalwhite yttria-stabilized zirconia abutment (PYRCA; BioHorizons, Birmingham, EEUU) with immersion in fluorescent liquid
Receives: Other: Implant placement and prothesis made with different types of abutment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month after prothesis restoration

  2. 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

    Measured: 1 year after prothesis restoration

Secondary outcomes (20)

  1. 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

    Measured: 1 month after prothesis restoration

  2. 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

    Measured: 1 year after prothesis restoration

  3. 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).

    Measured: 1 month after prothesis restoration

  4. 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).

    Measured: 1 year after prothesis restoration

  5. 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).

    Measured: 1 month after final prothesis

  6. 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).

    Measured: 1 year after prothesis restoration

  7. 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).

    Measured: Preoperatively

  8. Clinical outcomes

    Full mouth plaque index was recorded.

    Measured: Preoperatively

  9. Clinical outcomes

    bleeding on probing was recorded.

    Measured: Preoperatively

  10. 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).

    Measured: 1 month after prothesis restoration

  11. 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).

    Measured: 1 year after prothesis restoration

  12. Clinical Outcomes

    Full mouth plaque index were also be recorded.

    Measured: 1 month after final prothesis

  13. Clinical Outcomes

    Full mouth plaque index were also be recorded.

    Measured: 1 year after final prothesis

  14. Clinical outcomes

    mucosal recession at the implant (REC) was also recorded

    Measured: 1 month after prothesis restoration

  15. Clinical outcomes

    mucosal recession at the implant (REC) was also recorded

    Measured: 1 year after prothesis restoration

  16. Clinical outcomes

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

    Measured: 1 month after prothesis restoration

  17. Clinical outcomes

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

    Measured: 1 year after prothesis restoration

  18. 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.

    Measured: 1 year after prothesis restoration

  19. 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).

    Measured: 1 month after prothesis restoration

  20. 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).

    Measured: 1 year after prothesis restoration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start8 Jan 2018
  3. Primary completion22 Jan 2019
  4. Study completion20 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475249
Sponsor's protocol ID
EC14/2017
Status last verified
Jul 2022
First submitted
27 Jun 2022
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19228100

  • 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.

    PubMed 10635203

  • 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.

    PubMed 23297745

  • 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.

    PubMed 16307569

  • 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.

    PubMed 20059415

  • 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.

    PubMed 22533953

  • 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.

    PubMed 17655713

  • 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.

    PubMed 22533954

  • 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.

    PubMed 15777328

  • 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.

    PubMed 19397632

  • 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.

    PubMed 21062337

  • 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.

    PubMed 23025514

Questions about this trial

What is this clinical trial studying?

A study testing Implant placement and prothesis made with different types of abutment in people with Edentulous Alveolar Ridge in the Aesthetic Zone, run by Universidad Complutense de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The spectrophotometric outcome ΔE is the primary outcome of this study (time frame: 1 month after prothesis restoration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475249, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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