Peri-ImplantitisNCT05081076
Health of Peri-implant Tissues Adjacent to Zirconia
A study testing Glazing and Polishing in people with Peri-Implantitis, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Background: The control and maintenance of implants, bone tissue and soft tissue are fundamental for the clinical success of implant prostheses (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Glazing and Polishing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2021to 30 Sep 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healing time of at least two months for patients who underwent extraction in areas to be rehabilitated with implants
- Adequate bone volume at the implant site (ie, sufficient for placement of an implant of at least 3.3 mm in diameter and 6 mm in length) assessed by preoperative CT and clinical evaluation.
- Use of Straumann bone level or conical bone level implants, with NC or RC platforms.
Who cannot join
- Patients with systemic diseases (e.g., heart disease, leukocyte and coagulation disorders, metabolic disorders, immunosuppression)
- History of radiotherapy in the head and neck region
- Current treatment with steroids and/or bisphosphonates
- Neurological or psychiatric impairment that can interfere with good oral hygiene
- Smoking (more than 10 cigarettes a day)
- History of illicit drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontificia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90619900
About this study
Official title: Health of Peri-implant Tissues Adjacent to Glazed or Polished Zirconia Surface: a Randomized, Intra-subject, Clinical Trial
Background: The control and maintenance of implants, bone tissue and soft tissue are fundamental for the clinical success of implant prostheses (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time.
Objective: To prospectively assess whether the peri-implant health of soft and hard tissues adjacent to monolithic zirconia PSIs varies with the type of surface finish (glazed or polished). It will also be evaluated if the patient perceives any clinical, comfort or satisfaction difference.
Methodology: The study design is a randomized, prospective, paired clinical trial, with intra-subject comparison. The sample will consist of consecutive patients in need and indication for treatment with monolithic zirconia PSIs, attended at the Military Policlinic of Porto Alegre and in a private practice by a single specialist researcher. For each PSI, the allocation of a glazed or polished surface in contact with the soft gingival tissue will be randomized on the mesial and distal sides of the crown. Data will be collected by routine clinical and radiographic examination with a focus on peri-implant health (hygiene index, gingival bleeding index, crestal bone level), satisfaction questionnaire and intraoral images (thermography and photographs), after one week of installation of the PSI and in six months, one year and two years. The data will be analyzed by descriptive and inferential statistics, at the significance level of 0.05.
Read the detailed description
The control and maintenance of implant, bone and soft tissue are fundamental for the clinical success of prostheses over implants (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time.
AIM To prospectively assess whether the peri-implant health of soft and hard tissue adjacent to monolithic PSIs varies with the type of surface finish (glazed or polished).
METHODS The study design is a randomized, prospective, paired, clinical trial with intra-subject comparison, and the research protocol will follow the Resolution 466/12 of the Brazilian National Health Council and the Declaration of Helsinki.
Sample A non-probabilistic sample will consist of consecutive patients in need of treatment with unitary PSIs made of monolithic zirconia, being attended at the Military Polyclinic of Porto Alegre and in a private practice by the same specialist researcher (DBS). Patients will be selected according to the eligibility criteria.
Sample size calculation: In the systematic review of Linkevicius and Vaitelis (2015) on the effect of zirconia or titanium abutments on peri-implant tissues, the 11 clinical studies included for biological outcomes had samples from 11 to 81 patients, with 11 to 45 abutments. In a total of 145 zirconia abutments, 12 (8.2%) had biological complications. There is no current clinical studies on glaze and PSI polishing in monolithic zirconia and outcomes of peri-implant health. So, a priori, the initial sample will consist of 30 PSIs (30 pairs to be compared: Glaze vs. Polishing). The definitive sample size will be calculated after preliminary data analysis from the initial six months of data collection.
PSIs crowns will be made on metallic abutments (Variobase or Anatomic Abutment, Straumann) and milled in monolithic zirconia (Amann Girrbach, Austria), using a CAD/CAM technique with molding or intra-oral scanning and in-lab milling. For each PSI, the mesial and distal faces will receive one experimental treatment (surface finishing) at random, to be defined by drawing lots: glazed surface treatment (Ceramill Stain \& Glaze Kit), or polished surface treatment (polishing rubbers kit in the sequence indicated by the manufacturer - EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany).
All PSIs will be installed according to standardized clinical protocol in the routine of dental clinics where the patients will be seen. After installing the PSI, the clinical data will be collected by clinical-radiographic exam and photographs at the following times: after one week of installation of the PSI (T0 - baseline) and in six months (T1), one year (T2) and two years (T3) of follow-up.
Clinical-radiographic Examination A single trained examiner (D.B.S.) will carry out the collection of clinical and radiographic data for each PSI installed through non-invasive procedures already used in dentistry.
In the clinical exam the following aspects will be evaluated on each face (glazed or polished) of the PSI:
- Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation.
- Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions).
- Patient Satisfaction: a 100-mm visual analogue scale will be used
- Infrared thermography
- Radiographic evaluation for peri-implant levels analysis (potential bone loss)
Statistical analysis The data will be analyzed by descriptive and inferential statistics (alpha = 0.05).
- Conditions
- Peri-Implantitis
- Being tested
- Glazing, Polishing
- Keywords
- monolithic zirconia, dental implants, peri-implant tissues, surface finishing
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlazingDevice
The zirconia surface will be submitted to a vitrification procedure (glazing) in a specific ceramic oven using the Ceramill Stain \& Glaze Kit, following the manufacturer's instructions.
PolishingDevice
The zirconia surface will be submitted to a polishing procedure using a polishing rubbers kit in the sequence indicated by the manufacturer (EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany).
| Study group | Role | What they receive |
|---|---|---|
| Glazed surface | Active comparator | One side of the zirconia crown will receive glazed surface treatment according to standard laboratory procedure and manufacturer's recommendations (Ceramill Stain \& Glaze Kit). Receives: Device: Glazing |
| Polished surface | Experimental | The contralateral side of the zirconia crown will receive polished surface treatment (polishing rubbers kit in the sequence indicated by the manufacturer - EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany). Receives: Device: Polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Hygiene Index at six months
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Measured: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change from six-month Hygiene Index at one year
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Measured: from six months (T1) to one year (T2) of follow-up
Change from one-year Hygiene Index at two years
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Measured: from one year (T2) to two years (T3) of follow-up
Change from baseline Index of Gingival Bleeding at six months
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
Measured: from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Change from six-month Index of Gingival Bleeding at one year
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
Measured: from six months (T1) and one year (T2) of follow-up
Change from one-year Index of Gingival Bleeding at two years
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
Measured: from one year (T2) to two years (T3) of follow-up
Secondary outcomes (9)
Change in baseline Overal Satisfaction at six months
Patient Satisfaction: a 100-mm visual analogue scale will be used
Measured: from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Change in six-month Overal satisfaction at one year
Patient Satisfaction: a 100-mm visual analogue scale will be used
Measured: from six months (T1) to one year (T2) of follow-up
Change in one-year Overal satisfaction at two years
Patient Satisfaction: a 100-mm visual analogue scale will be used
Measured: from one year (T2) to two years (T3) of follow-up
Change in baseline Infrared thermography score at six months
Infrared termograms obtained from a portable infrared camera will be assessed with the dedicated software to obtain a score measure of each region of interest after calibration procedures
Measured: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change in six-month Infrared thermography score at one year
Infrared termograms obtained from a portable infrared camera will be assessed with the dedicated software to obtain a score measure of each region of interest after calibration procedures
Measured: from six months (T1) to one year (T2) of follow-up
Change in one-year Infrared thermography score at two years
Infrared termograms obtained from a portable infrared camera will be assessed with the dedicated software to obtain a score measure of each region of interest after calibration procedures
Measured: from one year (T2) to two years (T3) of follow-up
Change in baseline Bone loss at six months
Radiographic images will be analysed with a specific software for peri-implant level measurements at the vertical implant axis, at the mesial and distal sides
Measured: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change in six-month Bone loss at one year
Radiographic images will be analysed with a specific software for peri-implant level measurements at the vertical implant axis, at the mesial and distal sides
Measured: from six months (T1) to one year (T2) of follow-up
Change in one-year Bone loss at two years
Radiographic images will be analysed with a specific software for peri-implant level measurements at the vertical implant axis, at the mesial and distal sides
Measured: from one year (T2) to two years (T3) of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Aug 2021
- Primary completion31 Jul 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design is a randomized, prospective, paired, clinical trial with intra-subject comparison. Each zirconia crown to be placed over the dental implant has two sides (mesial and distal), which will receive a randomised surface finishing treatment in the laboratory fabrication procedure.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosemary SA Shinkai, DDS, PhD, Study chair, Pontificia Universidade Católica do Rio Grande do Sul (PUCRS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081076
- Sponsor's protocol ID
- CAAE 45255621.2.0000.5336
- Status last verified
- Dec 2023
- First submitted
- 14 Sep 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be shared with other researchers upon justified request.
Publications
Linkevicius T, Vaitelis J. The effect of zirconia or titanium as abutment material on soft peri-implant tissues: a systematic review and meta-analysis. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:139-47. doi: 10.1111/clr.12631. Epub 2015 Jun 13.
PubMed 26073346Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
PubMed 29926491Segalla DB, Villarinho EA, Correia ARM, Vigo A, Shinkai RSA. A within-subject comparison of short implants in the posterior region: retrospective study of up to 10 years. J Adv Prosthodont. 2021 Jun;13(3):172-179. doi: 10.4047/jap.2021.13.3.172. Epub 2021 Jun 25.
PubMed 34234927Villarinho EA, Triches DF, Alonso FR, Mezzomo LAM, Teixeira ER, Shinkai RSA. Risk factors for single crowns supported by short (6-mm) implants in the posterior region: A prospective clinical and radiographic study. Clin Implant Dent Relat Res. 2017 Aug;19(4):671-680. doi: 10.1111/cid.12494. Epub 2017 May 10.
PubMed 28493384
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health of Peri-implant Tissues Adjacent to Glazed or Polished Zirconia Surface: a Randomized, Intra-subject, Clinical Trial
- ClinicalTrials.gov ID
- NCT05081076
- Acronym / sponsor ID
- CAAE 45255621.2.0000.5336
- Conditions
- Peri-Implantitis
- Keywords
- monolithic zirconia, dental implants, peri-implant tissues, surface finishing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The control and maintenance of implants, bone tissue and soft tissue are fundamental for the clinical success of implant prostheses (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time.
Objective: To prospectively assess whether the peri-implant health of soft and hard tissues adjacent to monolithic zirconia PSIs varies with the type of surface finish (glazed or polished). It will also be evaluated if the patient perceives any clinical, comfort or satisfaction difference.
Methodology: The study design is a randomized, prospective, paired clinical trial, with intra-subject comparison. The sample will consist of consecutive patients in need and indication for treatment with monolithic zirconia PSIs, attended at the Military Policlinic of Porto Alegre and in a private practice by a single specialist researcher. For each PSI, the allocation of a glazed or polished surface in contact with the soft gingival tissue will be randomized on the mesial and distal sides of the crown. Data will be collected by routine clinical and radiographic examination with a focus on peri-implant health (hygiene index, gingival bleeding index, crestal bone level), satisfaction questionnaire and intraoral images (thermography and photographs), after one week of installation of the PSI and in six months, one year and two years. The data will be analyzed by descriptive and inferential statistics, at the significance level of 0.05.
Detailed description
The control and maintenance of implant, bone and soft tissue are fundamental for the clinical success of prostheses over implants (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time.
AIM To prospectively assess whether the peri-implant health of soft and hard tissue adjacent to monolithic PSIs varies with the type of surface finish (glazed or polished).
METHODS The study design is a randomized, prospective, paired, clinical trial with intra-subject comparison, and the research protocol will follow the Resolution 466/12 of the Brazilian National Health Council and the Declaration of Helsinki.
Sample A non-probabilistic sample will consist of consecutive patients in need of treatment with unitary PSIs made of monolithic zirconia, being attended at the Military Polyclinic of Porto Alegre and in a private practice by the same specialist researcher (DBS). Patients will be selected according to the eligibility criteria.
Sample size calculation: In the systematic review of Linkevicius and Vaitelis (2015) on the effect of zirconia or titanium abutments on peri-implant tissues, the 11 clinical studies included for biological outcomes had samples from 11 to 81 patients, with 11 to 45 abutments. In a total of 145 zirconia abutments, 12 (8.2%) had biological complications. There is no current clinical studies on glaze and PSI polishing in monolithic zirconia and outcomes of peri-implant health. So, a priori, the initial sample will consist of 30 PSIs (30 pairs to be compared: Glaze vs. Polishing). The definitive sample size will be calculated after preliminary data analysis from the initial six months of data collection.
PSIs crowns will be made on metallic abutments (Variobase or Anatomic Abutment, Straumann) and milled in monolithic zirconia (Amann Girrbach, Austria), using a CAD/CAM technique with molding or intra-oral scanning and in-lab milling. For each PSI, the mesial and distal faces will receive one experimental treatment (surface finishing) at random, to be defined by drawing lots: glazed surface treatment (Ceramill Stain \& Glaze Kit), or polished surface treatment (polishing rubbers kit in the sequence indicated by the manufacturer - EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany).
All PSIs will be installed according to standardized clinical protocol in the routine of dental clinics where the patients will be seen. After installing the PSI, the clinical data will be collected by clinical-radiographic exam and photographs at the following times: after one week of installation of the PSI (T0 - baseline) and in six months (T1), one year (T2) and two years (T3) of follow-up.
Clinical-radiographic Examination A single trained examiner (D.B.S.) will carry out the collection of clinical and radiographic data for each PSI installed through non-invasive procedures already used in dentistry.
In the clinical exam the following aspects will be evaluated on each face (glazed or polished) of the PSI:
- Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation.
- Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions).
- Patient Satisfaction: a 100-mm visual analogue scale will be used
- Infrared thermography
- Radiographic evaluation for peri-implant levels analysis (potential bone loss)
Statistical analysis The data will be analyzed by descriptive and inferential statistics (alpha = 0.05).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is a randomized, prospective, paired, clinical trial with intra-subject comparison. Each zirconia crown to be placed over the dental implant has two sides (mesial and distal), which will receive a randomised surface finishing treatment in the laboratory fabrication procedure.
| Arm | Type | Receives |
|---|---|---|
| Glazed surface | Active comparator | Device: GlazingOne side of the zirconia crown will receive glazed surface treatment according to standard laboratory procedure and manufacturer's recommendations (Ceramill Stain \& Glaze Kit). |
| Polished surface | Experimental | Device: PolishingThe contralateral side of the zirconia crown will receive polished surface treatment (polishing rubbers kit in the sequence indicated by the manufacturer - EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healing time of at least two months for patients who underwent extraction in areas to be rehabilitated with implants
- Adequate bone volume at the implant site (ie, sufficient for placement of an implant of at least 3.3 mm in diameter and 6 mm in length) assessed by preoperative CT and clinical evaluation.
- Use of Straumann bone level or conical bone level implants, with NC or RC platforms.
Key exclusion criteria (6 listed)
- Patients with systemic diseases (e.g., heart disease, leukocyte and coagulation disorders, metabolic disorders, immunosuppression)
- History of radiotherapy in the head and neck region
- Current treatment with steroids and/or bisphosphonates
- Neurological or psychiatric impairment that can interfere with good oral hygiene
- Smoking (more than 10 cigarettes a day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlazingThe zirconia surface will be submitted to a vitrification procedure (glazing) in a specific ceramic oven using the Ceramill Stain \& Glaze Kit, following the manufacturer's instructions. | Device | Glazed surface |
| PolishingThe zirconia surface will be submitted to a polishing procedure using a polishing rubbers kit in the sequence indicated by the manufacturer (EVE DIACERA Finishing and Polishing Kit, EVE Ernst Vetter GmbH - Germany). | Device | Polished surface |
Primary outcome
Change from baseline Hygiene Index at six months
Time frame: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Change from six-month Hygiene Index at one year
Time frame: from six months (T1) to one year (T2) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Change from one-year Hygiene Index at two years
Time frame: from one year (T2) to two years (T3) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Change from baseline Index of Gingival Bleeding at six months
Time frame: from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
Change from six-month Index of Gingival Bleeding at one year
Time frame: from six months (T1) and one year (T2) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
Change from one-year Index of Gingival Bleeding at two years
Time frame: from one year (T2) to two years (T3) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
9 secondary outcomes
Change in baseline Overal Satisfaction at six months
Time frame: from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Change in six-month Overal satisfaction at one year
Time frame: from six months (T1) to one year (T2) of follow-up
Change in one-year Overal satisfaction at two years
Time frame: from one year (T2) to two years (T3) of follow-up
Change in baseline Infrared thermography score at six months
Time frame: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change in six-month Infrared thermography score at one year
Time frame: from six months (T1) to one year (T2) of follow-up
Change in one-year Infrared thermography score at two years
Time frame: from one year (T2) to two years (T3) of follow-up
Change in baseline Bone loss at six months
Time frame: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Change in six-month Bone loss at one year
Time frame: from six months (T1) to one year (T2) of follow-up
Change in one-year Bone loss at two years
Time frame: from one year (T2) to two years (T3) of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 26073346Linkevicius T, Vaitelis J. The effect of zirconia or titanium as abutment material on soft peri-implant tissues: a systematic review and meta-analysis. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:139-47. doi: 10.1111/clr.12631. Epub 2015 Jun 13.
- Background: PubMed 29926491Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Background: PubMed 34234927Segalla DB, Villarinho EA, Correia ARM, Vigo A, Shinkai RSA. A within-subject comparison of short implants in the posterior region: retrospective study of up to 10 years. J Adv Prosthodont. 2021 Jun;13(3):172-179. doi: 10.4047/jap.2021.13.3.172. Epub 2021 Jun 25.
- Background: PubMed 28493384Villarinho EA, Triches DF, Alonso FR, Mezzomo LAM, Teixeira ER, Shinkai RSA. Risk factors for single crowns supported by short (6-mm) implants in the posterior region: A prospective clinical and radiographic study. Clin Implant Dent Relat Res. 2017 Aug;19(4):671-680. doi: 10.1111/cid.12494. Epub 2017 May 10.
- Individual participant dataSharing planned: No. IPD may be shared with other researchers upon justified request.
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Peri-Implantitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary SA Shinkai, DDS, PhD study chair
Pontificia Universidade Católica do Rio Grande do Sul (PUCRS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glazing and Polishing in people with Peri-Implantitis, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 6 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 11 Dec 2023. 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 Brazil. 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. 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?
Change from baseline Hygiene Index at six months (time frame: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up). The study lists 6 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 NCT05081076, which also lists 4 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 11 Dec 2023.