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Study protocol
Jianxia Hou
Corresponding Author
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• Background: Implant-supported prostheses are applied in edentulous patients with high success rate. However, the incidence rate of biological complications namely peri-implant mucositis and peri-implantitis increases year by year after the placement of prostheses. Pathogenic bacteria accumulated adjacent to prostheses is proved to be the main reason of biological complication. Titanium, one of the classical materials for implant-supported prostheses, performs well in the aspect of biocompatibility and ease maintenance, but is still susceptible for biofilm formation. Zirconia, emerging as an appealing substitute, not only has comparable properties, but presents different surface properties influencing oral bacteria adhesion. However, scarce scientific research proves its direct effect on oral bacteria flora. Study exploring the different effects of material properties on biofilm formation and composition might provide a clue on this topic.
• Methods: The proposed study is designed as a 5-year randomized controlled trial. We plan to enroll 36 edentulous (maxilla and/or mandible) patients seeking of full-arch fixed implant-supported prostheses. The participants will be randomly divided into two groups. Group 1: participants will be restored with zirconia frameworks with ceramic veneering; Group 2: participants will be restored with titanium frameworks with acrylic resin veneering. Ten reexaminations will be completed at the end of this 5-year trial. Mucosal conditions around the implants will be recorded every six months after restoration. Peri-implant submucosal plaque will be collected at each reexamination, and bacteria flora analysis will be performed with 16S rRNA gene sequencing technology, to compare the differences in microbial diversity between two groups. X-ray examination will be applied every 12 months as a key index to evaluate the marginal bone level around implants.
• Discussion: The current study aims to explore the oral microbiology of patients restored with zirconia ceramic frameworks and those restored with titanium frameworks. By evaluating and comparing the features of the microbiota and the mucosal condition around two different materials, whether zirconia to be a recommendable material for fixed implant-supported prostheses could be figured out. This study aims to provide a tangible decision-making suggestion for full arch implant-supported prosthesis in edentulous patients.
• Trial registration: International Clinical Trials Registry Platform (ICTRP), ID: ChiCTR2000029470. Registered on 2 February 2020.
Keywords
Dental implants, Edentulous, Microbiota, Bio-complication, Zirconia, Titanium
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CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 31 Oct, 2020
Reviewer #3 agreed
On 28 Oct, 2020
Review #3 received
Received 28 Oct, 2020
Reviewer #2 agreed
On 23 Sep, 2020
Review #2 received
Received 23 Sep, 2020
Reviewers invited
Invitations sent on 21 Sep, 2020
Reviewer #1 agreed
On 21 Sep, 2020
Review #1 received
Received 21 Sep, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 09 Sep, 2020
Version 1
Posted 13 May, 2020
No comments provided
Editorial decision: Major revision
On 11 Aug, 2020
Review #4 received
Received 04 Aug, 2020
Review #2 received
Received 30 Jul, 2020
Review #1 received
Received 18 Jul, 2020
Review #3 received
Received 15 Jul, 2020
Reviewer #4 agreed
On 09 Jul, 2020
Reviewer #3 agreed
On 08 Jul, 2020
Reviewer #2 agreed
On 07 Jul, 2020
Reviewers invited
Invitations sent on 06 Jul, 2020
Reviewer #1 agreed
On 06 Jul, 2020
Editor assigned
On 06 Jun, 2020
Submission checks complete
On 12 May, 2020
First submitted
On 02 Apr, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Jianxia Hou
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 31 Oct, 2020
Reviewer #3 agreed
On 28 Oct, 2020
Review #3 received
Received 28 Oct, 2020
Reviewer #2 agreed
On 23 Sep, 2020
Review #2 received
Received 23 Sep, 2020
Reviewers invited
Invitations sent on 21 Sep, 2020
Reviewer #1 agreed
On 21 Sep, 2020
Review #1 received
Received 21 Sep, 2020
Editor assigned
On 10 Sep, 2020
Submission checks complete
On 09 Sep, 2020
Version 1
Posted 13 May, 2020
No comments provided
Editorial decision: Major revision
On 11 Aug, 2020
Review #4 received
Received 04 Aug, 2020
Review #2 received
Received 30 Jul, 2020
Review #1 received
Received 18 Jul, 2020
Review #3 received
Received 15 Jul, 2020
Reviewer #4 agreed
On 09 Jul, 2020
Reviewer #3 agreed
On 08 Jul, 2020
Reviewer #2 agreed
On 07 Jul, 2020
Reviewers invited
Invitations sent on 06 Jul, 2020
Reviewer #1 agreed
On 06 Jul, 2020
Editor assigned
On 06 Jun, 2020
Submission checks complete
On 12 May, 2020
First submitted
On 02 Apr, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
• Background: Implant-supported prostheses are applied in edentulous patients with high success rate. However, the incidence rate of biological complications namely peri-implant mucositis and peri-implantitis increases year by year after the placement of prostheses. Pathogenic bacteria accumulated adjacent to prostheses is proved to be the main reason of biological complication. Titanium, one of the classical materials for implant-supported prostheses, performs well in the aspect of biocompatibility and ease maintenance, but is still susceptible for biofilm formation. Zirconia, emerging as an appealing substitute, not only has comparable properties, but presents different surface properties influencing oral bacteria adhesion. However, scarce scientific research proves its direct effect on oral bacteria flora. Study exploring the different effects of material properties on biofilm formation and composition might provide a clue on this topic.
• Methods: The proposed study is designed as a 5-year randomized controlled trial. We plan to enroll 36 edentulous (maxilla and/or mandible) patients seeking of full-arch fixed implant-supported prostheses. The participants will be randomly divided into two groups. Group 1: participants will be restored with zirconia frameworks with ceramic veneering; Group 2: participants will be restored with titanium frameworks with acrylic resin veneering. Ten reexaminations will be completed at the end of this 5-year trial. Mucosal conditions around the implants will be recorded every six months after restoration. Peri-implant submucosal plaque will be collected at each reexamination, and bacteria flora analysis will be performed with 16S rRNA gene sequencing technology, to compare the differences in microbial diversity between two groups. X-ray examination will be applied every 12 months as a key index to evaluate the marginal bone level around implants.
• Discussion: The current study aims to explore the oral microbiology of patients restored with zirconia ceramic frameworks and those restored with titanium frameworks. By evaluating and comparing the features of the microbiota and the mucosal condition around two different materials, whether zirconia to be a recommendable material for fixed implant-supported prostheses could be figured out. This study aims to provide a tangible decision-making suggestion for full arch implant-supported prosthesis in edentulous patients.
• Trial registration: International Clinical Trials Registry Platform (ICTRP), ID: ChiCTR2000029470. Registered on 2 February 2020.
Figure 1
Figure 2
Figure 3
Figure 4
This is a list of supplementary files associated with this preprint. Click to download.
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