Peri-Implantitis and Peri-implant MucositisNCT06619158
Effectiveness of Zirconia Glaze Removal and Polish in the Treatment of Peri-implant Mucositis
A study testing Crown modification in people with Peri-Implantitis and Peri-implant Mucositis, run by University of Manitoba at 1 site in Canada.
Trial summary
This clinical trial is being conducted to study peri-implant mucositis (inflammation in the gums around dental implant that does not extend into the implant-supporting bone). There are currently no available treatment options able to provide long-term resolution of implant gum inflammation even with our current gold… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis and Peri-implant Mucositis
- What is being tested?
- Crown modification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 1 single screw-retained zirconia glazed implant crown which is in function for at least 1 year, with adequate contact points, submucosal crown margins, no adjacent implants, adequate keratinized tissue (2mm or more), and peri-implant mucositis that persists despite recent (within the past 6 months) non-surgical debridement
Who cannot join
- Contraindications to routine dental treatment Open interproximal contacts, splinted implant prosthesis, peri-implant health, peri-implantitis, cemented crown , removable implant prosthesis, recession past the implant platform Systemic antibiotic use within the last 2 weeks heavy smokers (more than 10 cigarettes/day) uncontrolled diabetes (HbA1C more than 7.0%)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Dr Sam Borden Periodontology Specialty Clinic
Winnipeg, Manitoba, R3E 0W2
Daniel Su, DMD, 204-789-3426, perio.clinic@umanitoba.ca
About this study
Official title: Long-term Effectiveness of Zirconia Glaze Removal and Polish As an Adjunct to Non-surgical Therapy in Treatment of Persistent Peri-implant Mucositis
This clinical trial is being conducted to study peri-implant mucositis (inflammation in the gums around dental implant that does not extend into the implant-supporting bone). There are currently no available treatment options able to provide long-term resolution of implant gum inflammation even with our current gold standard treatment of non-surgical cleanings and oral hygiene instructions. The purpose of the study is to compare the effect of crown glaze removal and subsequent polishing in addition to mechanical debridement compared to only mechanical debridement on the implant affected by implant gum inflammation.
In this study, participants will be randomized (put into a group by chance) into one of 2 study groups, groups A and B.
Read more
Group A: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician who will remove the glaze and polish the crown only in the areas that sit under the gums.
Group B: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician to perform a superficial cleaning only.
In both groups, the crown will be placed back on the implant and customized oral hygiene instructions will be provided.
The study will require four appointment. Appointment #1 is the screening appointment and will take 30-60 minutes. Appointment #2 is when treatment is delivered and will occur within 4 weeks of appointment #1. Appointment #3 is for the short-term follow-up and will occur within 60-70 days of appointment #2. Appointment #4 is for the long-term follow-up and will occur within 12-13 months of appointment #2. All these appointment will be in an outpatient setting at the institutional graduate periodontics clinic.
A total of 2 x-rays will be taken of the implant. One will be taken during appointment #1 to assess the bone around the implant. One will be taken during appointment #2 to ensure that the crown is fully seated when the crown is re-inserted.
The following information will be collected in appointment #1: gum measurements around the implants, how tight the implant contacts adjacent teeth, when the crown was delivered, previous cleanings around the implant, age, sex, gender, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values.
At appointments #2, 3, and 4, the following information will be collected: plaque around implant, gum measurements around implants, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values, gum fluid samples around the implant crown. In appointment #4, additionally, information on how the implant has been cleaned throughout the year will be collected.
Read the detailed description
The study's objectives are:
- To determine whether a smooth crown surface (\<0.2 μm Ra) can be established in-vitro after glaze removal and polishing based on adapted protocol from Go et al., 2019.
- To determine the effectiveness of submucosal non-surgical hand and powered instrumentation in removal of plaque and calculus.
- To assess the short- and long-term effectiveness of submucosal zirconia glaze removal and polishing as an adjunct to non-surgical therapy for treatment of persistent peri-implant mucositis. The null hypothesis is that the polishing protocol will not produce any significant differences in the resolution of inflammation compared to crown removal as part of the non-surgical debridement.
- Being tested
- Crown modification
- Keywords
- zirconia glaze removal, crown modification
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crown modificationProcedure or surgery
Zirconia glaze removal and polish after crown removal to reduce roughness and prohibit plaque adhesion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Crown modification with glaze removal and polish of implant crown Receives: Procedure: Crown modification |
| Group B | No intervention | No intervention will be applied. The crown will be removed and superficially cleaned |
What is being measured
The primary outcome is the main question the study is designed to answer.
mBI long term
modified Bleeding index (mBI) around the implant long term (12 months following treatment)
Measured: 12 months following treatment
mBI short term
modified bleeding index (mBI) around the implant short term (60-70 days following treatment)
Measured: 60-70 days following treatment
residual plaque and calculus
% of plaque and calculus on the subgingival surface of crown
Measured: baseline
Secondary outcomes (28)
PI long term
plaque index (PI) around implant long term
Measured: 12 months following treatment
PD short term
probing depth (PD) around implant short term
Measured: 60-70 days following treatment
PD long term
probing depth (PD) around implant long term
Measured: 12 months following treatment
PI short term
plaque index (PI) around implant short term
Measured: 60-70 days following treatment
IL-1β baseline
level of IL-1β in the peri-implant crevicular fluid
Measured: baseline
IL-1β short-term
level of IL-1β in the peri-implant crevicular fluid
Measured: 60-70 days following treatment
IL-1β long-term
level of IL-1β in the peri-implant crevicular fluid
Measured: 12 months following treatment
INF-γ baseline
level of INF-γ in the peri-implant crevicular fluid
Measured: baseline
INF-γ short-term
level of INF-γ in the peri-implant crevicular fluid
Measured: 60-70 days following treatment
INF-γ long-term
level of INF-γ in the peri-implant crevicular fluid
Measured: 12 months following treatment
IL-2 baseline
level of IL-2 in peri-implant crevicular fluid
Measured: baseline
IL-2 short-term
level of IL-2 in the peri-implant crevicular fluid
Measured: 60-70 days following treatment
IL-2 long-term
level of IL-2 in the peri-implant crevicular fluid
Measured: 12 months following treatment
IL-4 baseline
level of IL-4 in the peri-implant crevicular fluid
Measured: baseline
IL-4 short-term
level of peri-implant crevicular fluid
Measured: 60-70 days following treatment
IL-4 long-term
level of IL-4 in the peri-implant crevicular fluid
Measured: 12 months following treatment
IL-6 baseline
level of IL-6 in peri-implant crevicular fluid
Measured: baseline
IL-6 short-term
level of IL-6 in peri-implant crevicular fluid
Measured: 60-70 days following treatment
Il-6 long-term
level of IL-6 in the peri-implant crevicular fluid
Measured: 12 months following treatment
IL-8 baseline
level of IL-8 in peri-implant crevicular fluid
Measured: baseline
IL-8 short-term
level of IL-8 in peri-implant crevicular fluid
Measured: 60-70 days following treatment
IL-8 long-term
level of IL-8 in peri-implant crevicular fluid
Measured: 12 months following treatment
IL-10 baseline
level of IL-10 in peri-implant crevicular fluid
Measured: baseline
IL-10 short term
level of IL-10 in peri-implant crevicular fluid
Measured: 60-70 days following treatment
IL-10 long-term
level of IL-10 in peri-implant crevicular fluid
Measured: 12 months following treatment
TNF-α baseline
level of TNF-α in peri-implant crevicular fluid
Measured: baseline
TNF-α short-term
level of TNF-α in peri-implant crevicular fluid
Measured: 60-70 days following treatment
TNF-α long-term
level of TNF-α in the peri-implant crevicular fluid
Measured: 12 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Peri-Implantitis and Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysi Stavropoulou, University of Manitoba
- Investigators
- Chrysi Stavropoulou, DDS, MDent(Perio), Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619158
- Sponsor's protocol ID
- H2024:048
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yu P, Wang C, Zhou J, Jiang L, Xue J, Li W. Influence of Surface Properties on Adhesion Forces and Attachment of Streptococcus mutans to Zirconia In Vitro. Biomed Res Int. 2016;2016:8901253. doi: 10.1155/2016/8901253. Epub 2016 Nov 15.
PubMed 27975061Tete S, Zizzari VL, Borelli B, De Colli M, Zara S, Sorrentino R, Scarano A, Gherlone E, Cataldi A, Zarone F. Proliferation and adhesion capability of human gingival fibroblasts onto zirconia, lithium disilicate and feldspathic veneering ceramic in vitro. Dent Mater J. 2014;33(1):7-15. doi: 10.4012/dmj.2013-185.
PubMed 24492105Tajti P, Solyom E, Czumbel LM, Szabo B, Fazekas R, Nemeth O, Hermann P, Gerber G, Hegyi P, Mikulas K. Monolithic zirconia as a valid alternative to metal-ceramic for implant-supported single crowns in the posterior region: A systematic review and meta-analysis of randomized controlled trials. J Prosthet Dent. 2024 Nov;132(5):881-889. doi: 10.1016/j.prosdent.2023.05.006. Epub 2023 Jun 21.
PubMed 37349158Sirinirund B, Siqueira R, Li J, Mendonca G, Zalucha J, Wang HL. Effects of crown contour on artificial biofilm removal efficacy with interdental cleaning aids: An in vitro study. Clin Oral Implants Res. 2023 Aug;34(8):783-792. doi: 10.1111/clr.14105. Epub 2023 Jun 3.
PubMed 37269176Scotti R, Zanini Kantorski K, Scotti N, Monaco C, Valandro LF, Bottino MA. Early biofilm colonization on polished- and glazed-zirconium ceramic surface. Preliminary results. Minerva Stomatol. 2006 Sep;55(9):493-502. English, Italian.
PubMed 17146428Renvert S, Hirooka H, Polyzois I, Kelekis-Cholakis A, Wang HL; Working Group 3. Diagnosis and non-surgical treatment of peri-implant diseases and maintenance care of patients with dental implants - Consensus report of working group 3. Int Dent J. 2019 Sep;69(Suppl 2):12-17. doi: 10.1111/idj.12490.
PubMed 31478575Priest G. A Current Perspective on Screw-Retained Single-Implant Restorations: A Review of Pertinent Literature. J Esthet Restor Dent. 2017 May 6;29(3):161-171. doi: 10.1111/jerd.12283. Epub 2017 Jan 23.
PubMed 28112854Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
PubMed 3507627Menezes KM, Fernandes-Costa AN, Silva-Neto RD, Calderon PS, Gurgel BC. Efficacy of 0.12% Chlorhexidine Gluconate for Non-Surgical Treatment of Peri-Implant Mucositis. J Periodontol. 2016 Nov;87(11):1305-1313. doi: 10.1902/jop.2016.160144. Epub 2016 Jul 8.
PubMed 27389963Lee CT, Huang YW, Zhu L, Weltman R. Prevalences of peri-implantitis and peri-implant mucositis: systematic review and meta-analysis. J Dent. 2017 Jul;62:1-12. doi: 10.1016/j.jdent.2017.04.011. Epub 2017 May 3.
PubMed 28478213Kim W, Li XC, Bidra AS. Clinical outcomes of implant-supported monolithic zirconia crowns and fixed partial dentures: A systematic review. J Prosthodont. 2023 Feb;32(2):102-107. doi: 10.1111/jopr.13575. Epub 2022 Aug 18.
PubMed 35929416Katafuchi M, Weinstein BF, Leroux BG, Chen YW, Daubert DM. Restoration contour is a risk indicator for peri-implantitis: A cross-sectional radiographic analysis. J Clin Periodontol. 2018 Feb;45(2):225-232. doi: 10.1111/jcpe.12829. Epub 2017 Dec 5.
PubMed 28985447Jepsen S, Berglundh T, Genco R, Aass AM, Demirel K, Derks J, Figuero E, Giovannoli JL, Goldstein M, Lambert F, Ortiz-Vigon A, Polyzois I, Salvi GE, Schwarz F, Serino G, Tomasi C, Zitzmann NU. Primary prevention of peri-implantitis: managing peri-implant mucositis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S152-7. doi: 10.1111/jcpe.12369.
PubMed 25626479Heitz-Mayfield LJ, Salvi GE, Botticelli D, Mombelli A, Faddy M, Lang NP; Implant Complication Research Group. Anti-infective treatment of peri-implant mucositis: a randomised controlled clinical trial. Clin Oral Implants Res. 2011 Mar;22(3):237-41. doi: 10.1111/j.1600-0501.2010.02078.x. Epub 2011 Jan 20.
PubMed 21251076Hallstrom H, Persson GR, Lindgren S, Olofsson M, Renvert S. Systemic antibiotics and debridement of peri-implant mucositis. A randomized clinical trial. J Clin Periodontol. 2012 Jun;39(6):574-81. doi: 10.1111/j.1600-051X.2012.01884.x.
PubMed 22571225
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness of Zirconia Glaze Removal and Polish As an Adjunct to Non-surgical Therapy in Treatment of Persistent Peri-implant Mucositis
- ClinicalTrials.gov ID
- NCT06619158
- Acronym / sponsor ID
- H2024:048
- Keywords
- zirconia glaze removal, crown modification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
This clinical trial is being conducted to study peri-implant mucositis (inflammation in the gums around dental implant that does not extend into the implant-supporting bone). There are currently no available treatment options able to provide long-term resolution of implant gum inflammation even with our current gold standard treatment of non-surgical cleanings and oral hygiene instructions. The purpose of the study is to compare the effect of crown glaze removal and subsequent polishing in addition to mechanical debridement compared to only mechanical debridement on the implant affected by implant gum inflammation.
In this study, participants will be randomized (put into a group by chance) into one of 2 study groups, groups A and B.
Group A: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician who will remove the glaze and polish the crown only in the areas that sit under the gums.
Group B: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician to perform a superficial cleaning only.
In both groups, the crown will be placed back on the implant and customized oral hygiene instructions will be provided.
The study will require four appointment. Appointment #1 is the screening appointment and will take 30-60 minutes. Appointment #2 is when treatment is delivered and will occur within 4 weeks of appointment #1. Appointment #3 is for the short-term follow-up and will occur within 60-70 days of appointment #2. Appointment #4 is for the long-term follow-up and will occur within 12-13 months of appointment #2. All these appointment will be in an outpatient setting at the institutional graduate periodontics clinic.
A total of 2 x-rays will be taken of the implant. One will be taken during appointment #1 to assess the bone around the implant. One will be taken during appointment #2 to ensure that the crown is fully seated when the crown is re-inserted.
The following information will be collected in appointment #1: gum measurements around the implants, how tight the implant contacts adjacent teeth, when the crown was delivered, previous cleanings around the implant, age, sex, gender, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values.
At appointments #2, 3, and 4, the following information will be collected: plaque around implant, gum measurements around implants, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values, gum fluid samples around the implant crown. In appointment #4, additionally, information on how the implant has been cleaned throughout the year will be collected.
Detailed description
The study's objectives are:
- To determine whether a smooth crown surface (\<0.2 μm Ra) can be established in-vitro after glaze removal and polishing based on adapted protocol from Go et al., 2019.
- To determine the effectiveness of submucosal non-surgical hand and powered instrumentation in removal of plaque and calculus.
- To assess the short- and long-term effectiveness of submucosal zirconia glaze removal and polishing as an adjunct to non-surgical therapy for treatment of persistent peri-implant mucositis. The null hypothesis is that the polishing protocol will not produce any significant differences in the resolution of inflammation compared to crown removal as part of the non-surgical debridement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Crown modificationCrown modification with glaze removal and polish of implant crown |
| Group B | No intervention | –No intervention will be applied. The crown will be removed and superficially cleaned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 1 single screw-retained zirconia glazed implant crown which is in function for at least 1 year, with adequate contact points, submucosal crown margins, no adjacent implants, adequate keratinized tissue (2mm or more), and peri-implant mucositis that persists despite recent (within the past 6 months) non-surgical debridement
Key exclusion criteria (1 listed)
- Contraindications to routine dental treatment Open interproximal contacts, splinted implant prosthesis, peri-implant health, peri-implantitis, cemented crown , removable implant prosthesis, recession past the implant platform Systemic antibiotic use within the last 2 weeks heavy smokers (more than 10 cigarettes/day) uncontrolled diabetes (HbA1C more than 7.0%)
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 |
|---|---|---|
| Crown modificationZirconia glaze removal and polish after crown removal to reduce roughness and prohibit plaque adhesion | Procedure or surgery | Group A |
Primary outcome
mBI long term
Time frame: 12 months following treatment
modified Bleeding index (mBI) around the implant long term (12 months following treatment)
mBI short term
Time frame: 60-70 days following treatment
modified bleeding index (mBI) around the implant short term (60-70 days following treatment)
residual plaque and calculus
Time frame: baseline
% of plaque and calculus on the subgingival surface of crown
28 secondary outcomes
PI long term
Time frame: 12 months following treatment
PD short term
Time frame: 60-70 days following treatment
PD long term
Time frame: 12 months following treatment
PI short term
Time frame: 60-70 days following treatment
IL-1β baseline
Time frame: baseline
IL-1β short-term
Time frame: 60-70 days following treatment
IL-1β long-term
Time frame: 12 months following treatment
INF-γ baseline
Time frame: baseline
INF-γ short-term
Time frame: 60-70 days following treatment
INF-γ long-term
Time frame: 12 months following treatment
IL-2 baseline
Time frame: baseline
IL-2 short-term
Time frame: 60-70 days following treatment
IL-2 long-term
Time frame: 12 months following treatment
IL-4 baseline
Time frame: baseline
IL-4 short-term
Time frame: 60-70 days following treatment
IL-4 long-term
Time frame: 12 months following treatment
IL-6 baseline
Time frame: baseline
IL-6 short-term
Time frame: 60-70 days following treatment
Il-6 long-term
Time frame: 12 months following treatment
IL-8 baseline
Time frame: baseline
IL-8 short-term
Time frame: 60-70 days following treatment
IL-8 long-term
Time frame: 12 months following treatment
IL-10 baseline
Time frame: baseline
IL-10 short term
Time frame: 60-70 days following treatment
IL-10 long-term
Time frame: 12 months following treatment
TNF-α baseline
Time frame: baseline
TNF-α short-term
Time frame: 60-70 days following treatment
TNF-α long-term
Time frame: 12 months following treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 27975061Yu P, Wang C, Zhou J, Jiang L, Xue J, Li W. Influence of Surface Properties on Adhesion Forces and Attachment of Streptococcus mutans to Zirconia In Vitro. Biomed Res Int. 2016;2016:8901253. doi: 10.1155/2016/8901253. Epub 2016 Nov 15.
- Background: PubMed 24492105Tete S, Zizzari VL, Borelli B, De Colli M, Zara S, Sorrentino R, Scarano A, Gherlone E, Cataldi A, Zarone F. Proliferation and adhesion capability of human gingival fibroblasts onto zirconia, lithium disilicate and feldspathic veneering ceramic in vitro. Dent Mater J. 2014;33(1):7-15. doi: 10.4012/dmj.2013-185.
- Background: PubMed 37349158Tajti P, Solyom E, Czumbel LM, Szabo B, Fazekas R, Nemeth O, Hermann P, Gerber G, Hegyi P, Mikulas K. Monolithic zirconia as a valid alternative to metal-ceramic for implant-supported single crowns in the posterior region: A systematic review and meta-analysis of randomized controlled trials. J Prosthet Dent. 2024 Nov;132(5):881-889. doi: 10.1016/j.prosdent.2023.05.006. Epub 2023 Jun 21.
- Background: PubMed 37269176Sirinirund B, Siqueira R, Li J, Mendonca G, Zalucha J, Wang HL. Effects of crown contour on artificial biofilm removal efficacy with interdental cleaning aids: An in vitro study. Clin Oral Implants Res. 2023 Aug;34(8):783-792. doi: 10.1111/clr.14105. Epub 2023 Jun 3.
- Background: PubMed 17146428Scotti R, Zanini Kantorski K, Scotti N, Monaco C, Valandro LF, Bottino MA. Early biofilm colonization on polished- and glazed-zirconium ceramic surface. Preliminary results. Minerva Stomatol. 2006 Sep;55(9):493-502. English, Italian.
- Background: PubMed 31478575Renvert S, Hirooka H, Polyzois I, Kelekis-Cholakis A, Wang HL; Working Group 3. Diagnosis and non-surgical treatment of peri-implant diseases and maintenance care of patients with dental implants - Consensus report of working group 3. Int Dent J. 2019 Sep;69(Suppl 2):12-17. doi: 10.1111/idj.12490.
- Background: PubMed 28112854Priest G. A Current Perspective on Screw-Retained Single-Implant Restorations: A Review of Pertinent Literature. J Esthet Restor Dent. 2017 May 6;29(3):161-171. doi: 10.1111/jerd.12283. Epub 2017 Jan 23.
- Background: PubMed 3507627Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
- Background: PubMed 27389963Menezes KM, Fernandes-Costa AN, Silva-Neto RD, Calderon PS, Gurgel BC. Efficacy of 0.12% Chlorhexidine Gluconate for Non-Surgical Treatment of Peri-Implant Mucositis. J Periodontol. 2016 Nov;87(11):1305-1313. doi: 10.1902/jop.2016.160144. Epub 2016 Jul 8.
- Background: PubMed 28478213Lee CT, Huang YW, Zhu L, Weltman R. Prevalences of peri-implantitis and peri-implant mucositis: systematic review and meta-analysis. J Dent. 2017 Jul;62:1-12. doi: 10.1016/j.jdent.2017.04.011. Epub 2017 May 3.
- Background: PubMed 35929416Kim W, Li XC, Bidra AS. Clinical outcomes of implant-supported monolithic zirconia crowns and fixed partial dentures: A systematic review. J Prosthodont. 2023 Feb;32(2):102-107. doi: 10.1111/jopr.13575. Epub 2022 Aug 18.
- Background: PubMed 28985447Katafuchi M, Weinstein BF, Leroux BG, Chen YW, Daubert DM. Restoration contour is a risk indicator for peri-implantitis: A cross-sectional radiographic analysis. J Clin Periodontol. 2018 Feb;45(2):225-232. doi: 10.1111/jcpe.12829. Epub 2017 Dec 5.
- Individual participant dataSharing planned: Undecided
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Active, not recruitingObservational study
Evaluation of aMMP-8 and IL-1β Levels and Marginal Bone Loss Associated With Peri-Implant Mucositis and Peri-Implantitis in Postmenopausal Women
Postmenopausal Peri-implant Health, Postmenopausal Peri-mucositis
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.
Chrysi Stavropoulou, DDS, MDent(Perio) principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crown modification in people with Peri-Implantitis and Peri-implant Mucositis, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Oct 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chrysi Stavropoulou, DDS, MDent(Perio) (204-272-3075, chrysi.stavropoulou@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mBI long term (time frame: 12 months following treatment). The study lists 3 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 NCT06619158, which also lists 21 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 1 Oct 2024.