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Completed

NCT Number: NCT05475249

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

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.

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Key information

Conditions

Edentulous Alveolar Ridge in the Aesthetic Zone

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leticia

Madrid, 28023, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implant placement and prothesis made with different types of abutment

Other

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 outcomes

  1. The spectrophotometric outcome ΔE is the primary outcome of this study

    Time frame: 1 month after prothesis restoration

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

  2. The spectrophotometric outcome ΔE is the primary outcome of this study

    Time frame: 1 year after prothesis restoration

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

Secondary outcomes

  1. Subjective aesthetic outcomes

    Time frame: 1 month after prothesis restoration

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

  2. Subjective aesthetic outcomes

    Time frame: 1 year after prothesis restoration

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

  3. Biological complications

    Time frame: 1 month after prothesis restoration

    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).

  4. Biological Complications

    Time frame: 1 year after prothesis restoration

    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).

  5. Technical complications

    Time frame: 1 month after final prothesis

    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).

  6. Technical complications

    Time frame: 1 year after prothesis restoration

    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).

  7. Clinical outcomes

    Time frame: Preoperatively

    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).

  8. Clinical outcomes

    Time frame: Preoperatively

    Full mouth plaque index was recorded.

  9. Clinical outcomes

    Time frame: Preoperatively

    bleeding on probing was recorded.

  10. Clinical outcomes

    Time frame: 1 month after prothesis restoration

    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).

  11. Clinical outcomes

    Time frame: 1 year after prothesis restoration

    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).

  12. Clinical Outcomes

    Time frame: 1 month after final prothesis

    Full mouth plaque index were also be recorded.

  13. Clinical Outcomes

    Time frame: 1 year after final prothesis

    Full mouth plaque index were also be recorded.

  14. Clinical outcomes

    Time frame: 1 month after prothesis restoration

    mucosal recession at the implant (REC) was also recorded

  15. Clinical outcomes

    Time frame: 1 year after prothesis restoration

    mucosal recession at the implant (REC) was also recorded

  16. Clinical outcomes

    Time frame: 1 month after prothesis restoration

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

  17. Clinical outcomes

    Time frame: 1 year after prothesis restoration

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

  18. Radiographic outcomes

    Time frame: 1 year after prothesis restoration

    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.

  19. Patient centred outcomes

    Time frame: 1 month after prothesis restoration

    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).

  20. Patient centred outcomes

    Time frame: 1 year after prothesis restoration

    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).

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jul 26, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.