Peri-implant MucositisNCT03998865
Bacterial Microbiota Characterization on Implant-supported PEEK and Titanium Provisional Abutments
A study testing Provisional abutment material in people with Peri-implant Mucositis and Oral Bacterial Infection, run by Michael Wendler Ernst at 1 site in Chile.
Trial summary
The aim of this study is to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK implant-supported provisional abutments compared to titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Oral Bacterial Infection, Bacterial Resistance
- What is being tested?
- Provisional abutment material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChile
- Study dates
- 8 May 2019to 11 Dec 2019
- 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
- ASA I patients
- Indication of implant treatment to replace an upper or lower premolar
- Presence of natural teeth adjacent to the implant region
- Gingival biotype in the posterior region of 3 to 4 mm
Who cannot join
- Immunosuppressed patients
- Tabacco, alcohol or drug addictions
- History of periodontal disease
- Need of bone grafting in the implant region
Trial locations and contacts
1 site in 1 country.
Chile1 site
Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion
Concepción, Biobio, 4070369
About this study
Official title: Bacterial Microbiota and Its Relation to Antimicrobial Resistance Genes in Implant-supported PEEK and Titanium Provisional Abutments
The aim of this study is to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK implant-supported provisional abutments compared to titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
Read the detailed description
The use of provisional abutments is mandatory during the restorative phase of any implant based oral rehabilitation. The introduction of poly-ether-ether-ketone (PEEK) for the manufacturing of provisional abutments as an alternative to conventional titanium abutments has opened the restorative spectra, offering the clinician and the patient better aesthetics and adhesive outcomes than its predecessor. However, there is to date no clarity on the impact of PEEK on the bacterial growth and the specificity of the microbiota on the abutment surface. Therefore, the present study aims to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK and titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
Study Hypotheses:
- H1: The characteristics of the bacterial microbiota present at the connection area of implant-supported provisional abutments are dependent upon the abutment material.
- H2: An increased presence of antibiotic resistance genes is found in the bacterial microbiota on titanium provisional abutments when compared to that found on PEEK abutments.
The study uses a metagenomic approach based on the characterization of the bacterial communities, as well as on the sequencing of the 16S gene, and on the other hand, on the sequencing of the high-throughput (HTS) of the whole genome, for variations of the antibiotic resistance genes.
Sample retrieval will be conducted prior to implant placement, at the adjacent teeth gingival sulcus (t0), and two months after provisional abutment (and crown) connection (t1), from the retrieved abutments. Patient allocation in the "PEEK" or "Titanium" groups will be randomized. Intra- and interpatient comparisons will be conducted. Statistical analyses include two-way ANOVA and Tukey's post-hoc test, at p<0.05.
- Being tested
- Provisional abutment material
- Keywords
- Implant-supported Provisional Abutment, Poly-ether-ether-ketone, Titanium, Bacterial Microbiota, Antimicrobial Resistance Genes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provisional abutment materialDevice
The effect of the provisional abutment material on the characteristics of the bacterial microbiota will be assessed by using PEEK (experimental) or Titanium (active comparator) provisional abutments.
| Study group | Role | What they receive |
|---|---|---|
| PEEK Provisional Abutment | Experimental | The provisional crown will be fixed onto a PEEK abutment and then connected to the implant. The bis-acrylic resin used for the provisional crown will not invade the emergence profile of the abutment. Receives: Device: Provisional abutment material |
| Titanium Provisional Abutment | Active comparator | The provisional crown will be fixed onto a titanium abutment and then connected to the implant. The bis-acrylic resin used for the provisional crown will not invade the emergence profile of the abutment. Receives: Device: Provisional abutment material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Number of Operational Taxonomic Units (OTUS)
Changes in the Number of Operational Taxonomic Units (OTUS) observed after the two months evaluation period will be assessed using UniFrac metrics. The weighted UniFrac distances will be used to perform a principal coordinate analysis (PCO).
Measured: Baseline (prior to abutment insertion) and two months after abutment insertion.
Changes in Antibacterial Resistance Genes (ARG)
Changes in the ARG of the microbiota will be determined using the whole genome sequencing using the MiSeq Illumina method.
Measured: Baseline (prior to abutment insertion) and two months after abutment insertion.
Secondary outcomes (1)
Changes in the number of bacterial species
Changes in the bacterial microbiota richness will be evaluated using a bias corrected Chao 1 richness estimator and the Shannon diversity index.
Measured: Baseline (prior to abutment insertion) and two months after abutment insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start8 May 2019
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups: PEEK or Titanium provisional-abutments. A sample of the niche microbiota will be retrieved prior to implant placement (t0) and two months after provisional abutment (crown) connection (t1).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Wendler Ernst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Wendler Ernst, University of Concepcion, Chile
- Investigators
- Michael U Wendler, DDS, PhD, Principal investigator, Department of Restorative Dentistry, University of Concepcion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998865
- Sponsor's protocol ID
- 218.102.032-1.0IN
- Status last verified
- Dec 2019
- First submitted
- 12 Jun 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be communicated, in accordance with the ethical approval of the study. Data will be communicated grouped with the individual effects on the results assessed with the respective statistical tools.
Publications
Schwitalla AD, Abou-Emara M, Zimmermann T, Spintig T, Beuer F, Lackmann J, Muller WD. The applicability of PEEK-based abutment screws. J Mech Behav Biomed Mater. 2016 Oct;63:244-251. doi: 10.1016/j.jmbbm.2016.06.024. Epub 2016 Jul 1.
PubMed 27434650Mawhinney J, Connolly E, Claffey N, Moran G, Polyzois I. An in vivo comparison of internal bacterial colonization in two dental implant systems: identification of a pathogenic reservoir. Acta Odontol Scand. 2015 Apr;73(3):188-94. doi: 10.3109/00016357.2014.978365. Epub 2014 Nov 11.
PubMed 25385682Barbosa RE, do Nascimento C, Issa JP, Watanabe E, Ito IY, de Albuquerque RF Jr. Bacterial culture and DNA Checkerboard for the detection of internal contamination in dental implants. J Prosthodont. 2009 Jul;18(5):376-81. doi: 10.1111/j.1532-849X.2009.00454.x. Epub 2009 Apr 3.
PubMed 19374709Broggini N, McManus LM, Hermann JS, Medina RU, Oates TW, Schenk RK, Buser D, Mellonig JT, Cochran DL. Persistent acute inflammation at the implant-abutment interface. J Dent Res. 2003 Mar;82(3):232-7. doi: 10.1177/154405910308200316.
PubMed 12598555Subramani K, Jung RE, Molenberg A, Hammerle CH. Biofilm on dental implants: a review of the literature. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):616-26.
PubMed 19885401Campoccia D, Montanaro L, Arciola CR. The significance of infection related to orthopedic devices and issues of antibiotic resistance. Biomaterials. 2006 Apr;27(11):2331-9. doi: 10.1016/j.biomaterials.2005.11.044. Epub 2005 Dec 20.
PubMed 16364434Romanos GE, Biltucci MT, Kokaras A, Paster BJ. Bacterial Composition at the Implant-Abutment Connection under Loading in vivo. Clin Implant Dent Relat Res. 2016 Feb;18(1):138-45. doi: 10.1111/cid.12270. Epub 2014 Sep 5.
PubMed 25195711Weber DJ, Rutala WA. Self-disinfecting surfaces: review of current methodologies and future prospects. Am J Infect Control. 2013 May;41(5 Suppl):S31-5. doi: 10.1016/j.ajic.2012.12.005.
PubMed 23622745Baker-Austin C, Wright MS, Stepanauskas R, McArthur JV. Co-selection of antibiotic and metal resistance. Trends Microbiol. 2006 Apr;14(4):176-82. doi: 10.1016/j.tim.2006.02.006. Epub 2006 Mar 14.
PubMed 16537105Di Cello F, Pepi M, Baldi F, Fani R. Molecular characterization of an n-alkane-degrading bacterial community and identification of a new species, Acinetobacter venetianus. Res Microbiol. 1997 Mar-Apr;148(3):237-49. doi: 10.1016/S0923-2508(97)85244-8.
PubMed 9765804Diaz PI, Dupuy AK, Abusleme L, Reese B, Obergfell C, Choquette L, Dongari-Bagtzoglou A, Peterson DE, Terzi E, Strausbaugh LD. Using high throughput sequencing to explore the biodiversity in oral bacterial communities. Mol Oral Microbiol. 2012 Jun;27(3):182-201. doi: 10.1111/j.2041-1014.2012.00642.x. Epub 2012 Mar 3.
PubMed 22520388Sanchez-Sanhueza G, Bello-Toledo H, Gonzalez-Rocha G, Goncalves AT, Valenzuela V, Gallardo-Escarate C. Metagenomic study of bacterial microbiota in persistent endodontic infections using Next-generation sequencing. Int Endod J. 2018 Dec;51(12):1336-1348. doi: 10.1111/iej.12953. Epub 2018 Jun 9.
PubMed 29786880
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Microbiota and Its Relation to Antimicrobial Resistance Genes in Implant-supported PEEK and Titanium Provisional Abutments
- ClinicalTrials.gov ID
- NCT03998865
- Acronym / sponsor ID
- 218.102.032-1.0IN
- Keywords
- Implant-supported Provisional Abutment, Poly-ether-ether-ketone, Titanium, Bacterial Microbiota, Antimicrobial Resistance Genes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Michael Wendler ErnstUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 26 Jun 2019 (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.
The aim of this study is to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK implant-supported provisional abutments compared to titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
Detailed description
The use of provisional abutments is mandatory during the restorative phase of any implant based oral rehabilitation. The introduction of poly-ether-ether-ketone (PEEK) for the manufacturing of provisional abutments as an alternative to conventional titanium abutments has opened the restorative spectra, offering the clinician and the patient better aesthetics and adhesive outcomes than its predecessor. However, there is to date no clarity on the impact of PEEK on the bacterial growth and the specificity of the microbiota on the abutment surface. Therefore, the present study aims to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK and titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
Study Hypotheses:
- H1: The characteristics of the bacterial microbiota present at the connection area of implant-supported provisional abutments are dependent upon the abutment material.
- H2: An increased presence of antibiotic resistance genes is found in the bacterial microbiota on titanium provisional abutments when compared to that found on PEEK abutments.
The study uses a metagenomic approach based on the characterization of the bacterial communities, as well as on the sequencing of the 16S gene, and on the other hand, on the sequencing of the high-throughput (HTS) of the whole genome, for variations of the antibiotic resistance genes.
Sample retrieval will be conducted prior to implant placement, at the adjacent teeth gingival sulcus (t0), and two months after provisional abutment (and crown) connection (t1), from the retrieved abutments. Patient allocation in the "PEEK" or "Titanium" groups will be randomized. Intra- and interpatient comparisons will be conducted. Statistical analyses include two-way ANOVA and Tukey's post-hoc test, at p<0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: PEEK or Titanium provisional-abutments. A sample of the niche microbiota will be retrieved prior to implant placement (t0) and two months after provisional abutment (crown) connection (t1).
| Arm | Type | Receives |
|---|---|---|
| PEEK Provisional Abutment | Experimental | Device: Provisional abutment materialThe provisional crown will be fixed onto a PEEK abutment and then connected to the implant. The bis-acrylic resin used for the provisional crown will not invade the emergence profile of the abutment. |
| Titanium Provisional Abutment | Active comparator | Device: Provisional abutment materialThe provisional crown will be fixed onto a titanium abutment and then connected to the implant. The bis-acrylic resin used for the provisional crown will not invade the emergence profile of the abutment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I patients
- Indication of implant treatment to replace an upper or lower premolar
- Presence of natural teeth adjacent to the implant region
- Gingival biotype in the posterior region of 3 to 4 mm
Key exclusion criteria (4 listed)
- Immunosuppressed patients
- Tabacco, alcohol or drug addictions
- History of periodontal disease
- Need of bone grafting in the implant region
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 |
|---|---|---|
| Provisional abutment materialThe effect of the provisional abutment material on the characteristics of the bacterial microbiota will be assessed by using PEEK (experimental) or Titanium (active comparator) provisional abutments. | Device | PEEK Provisional Abutment, Titanium Provisional Abutment |
Primary outcome
Changes in the Number of Operational Taxonomic Units (OTUS)
Time frame: Baseline (prior to abutment insertion) and two months after abutment insertion.
Changes in the Number of Operational Taxonomic Units (OTUS) observed after the two months evaluation period will be assessed using UniFrac metrics. The weighted UniFrac distances will be used to perform a principal coordinate analysis (PCO).
Changes in Antibacterial Resistance Genes (ARG)
Time frame: Baseline (prior to abutment insertion) and two months after abutment insertion.
Changes in the ARG of the microbiota will be determined using the whole genome sequencing using the MiSeq Illumina method.
1 secondary outcome
Changes in the number of bacterial species
Time frame: Baseline (prior to abutment insertion) and two months after abutment insertion.
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 20 Dec 2019.
- Background: PubMed 27434650Schwitalla AD, Abou-Emara M, Zimmermann T, Spintig T, Beuer F, Lackmann J, Muller WD. The applicability of PEEK-based abutment screws. J Mech Behav Biomed Mater. 2016 Oct;63:244-251. doi: 10.1016/j.jmbbm.2016.06.024. Epub 2016 Jul 1.
- Background: PubMed 25385682Mawhinney J, Connolly E, Claffey N, Moran G, Polyzois I. An in vivo comparison of internal bacterial colonization in two dental implant systems: identification of a pathogenic reservoir. Acta Odontol Scand. 2015 Apr;73(3):188-94. doi: 10.3109/00016357.2014.978365. Epub 2014 Nov 11.
- Background: PubMed 19374709Barbosa RE, do Nascimento C, Issa JP, Watanabe E, Ito IY, de Albuquerque RF Jr. Bacterial culture and DNA Checkerboard for the detection of internal contamination in dental implants. J Prosthodont. 2009 Jul;18(5):376-81. doi: 10.1111/j.1532-849X.2009.00454.x. Epub 2009 Apr 3.
- Background: PubMed 12598555Broggini N, McManus LM, Hermann JS, Medina RU, Oates TW, Schenk RK, Buser D, Mellonig JT, Cochran DL. Persistent acute inflammation at the implant-abutment interface. J Dent Res. 2003 Mar;82(3):232-7. doi: 10.1177/154405910308200316.
- Background: PubMed 19885401Subramani K, Jung RE, Molenberg A, Hammerle CH. Biofilm on dental implants: a review of the literature. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):616-26.
- Background: PubMed 16364434Campoccia D, Montanaro L, Arciola CR. The significance of infection related to orthopedic devices and issues of antibiotic resistance. Biomaterials. 2006 Apr;27(11):2331-9. doi: 10.1016/j.biomaterials.2005.11.044. Epub 2005 Dec 20.
- Background: PubMed 25195711Romanos GE, Biltucci MT, Kokaras A, Paster BJ. Bacterial Composition at the Implant-Abutment Connection under Loading in vivo. Clin Implant Dent Relat Res. 2016 Feb;18(1):138-45. doi: 10.1111/cid.12270. Epub 2014 Sep 5.
- Background: PubMed 23622745Weber DJ, Rutala WA. Self-disinfecting surfaces: review of current methodologies and future prospects. Am J Infect Control. 2013 May;41(5 Suppl):S31-5. doi: 10.1016/j.ajic.2012.12.005.
- Background: PubMed 16537105Baker-Austin C, Wright MS, Stepanauskas R, McArthur JV. Co-selection of antibiotic and metal resistance. Trends Microbiol. 2006 Apr;14(4):176-82. doi: 10.1016/j.tim.2006.02.006. Epub 2006 Mar 14.
- Background: PubMed 9765804Di Cello F, Pepi M, Baldi F, Fani R. Molecular characterization of an n-alkane-degrading bacterial community and identification of a new species, Acinetobacter venetianus. Res Microbiol. 1997 Mar-Apr;148(3):237-49. doi: 10.1016/S0923-2508(97)85244-8.
- Background: PubMed 22520388Diaz PI, Dupuy AK, Abusleme L, Reese B, Obergfell C, Choquette L, Dongari-Bagtzoglou A, Peterson DE, Terzi E, Strausbaugh LD. Using high throughput sequencing to explore the biodiversity in oral bacterial communities. Mol Oral Microbiol. 2012 Jun;27(3):182-201. doi: 10.1111/j.2041-1014.2012.00642.x. Epub 2012 Mar 3.
- Background: PubMed 29786880Sanchez-Sanhueza G, Bello-Toledo H, Gonzalez-Rocha G, Goncalves AT, Valenzuela V, Gallardo-Escarate C. Metagenomic study of bacterial microbiota in persistent endodontic infections using Next-generation sequencing. Int Endod J. 2018 Dec;51(12):1336-1348. doi: 10.1111/iej.12953. Epub 2018 Jun 9.
- Individual participant dataSharing planned: No. No individual participant data will be communicated, in accordance with the ethical approval of the study. Data will be communicated grouped with the individual effects on the results assessed with the respective statistical tools.
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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.
Michael U Wendler, DDS, PhD principal investigator
Department of Restorative Dentistry, University of Concepcion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provisional abutment material in people with Peri-implant Mucositis and Oral Bacterial Infection, run by Michael Wendler Ernst at 1 site in Chile.
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 4 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 20 Dec 2019. 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 Chile. 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?
Changes in the Number of Operational Taxonomic Units (OTUS) (time frame: Baseline (prior to abutment insertion) and two months after abutment insertion.). 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 NCT03998865, 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 20 Dec 2019; AzTrials last refreshed its copy on 26 Oct 2026.