Peri-Implant HealthNCT07456163
Influence of Zirconia Abutments on Peri-Implant Tissues in Single-Tooth Restorations
A study testing Pre-fabricated standardized titanium abutments and Customized anatomical zirconia abutments in people with Peri-Implant Health and Implant Complication, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Objectives: To compare the influence of pre-fabricated titanium abutments and customized milled zirconia abutments on implant biocompatibility and the peri-implant region, as well as on radiographic bone loss and oral health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Health, Implant Complication, Prosthesis and Implants
- What is being tested?
- Pre-fabricated standardized titanium abutments and Customized anatomical zirconia abutments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Apr 2025to 1 Dec 2027
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years or older;
- Participants in the Master's Thesis entitled: "Dimensional Changes Following Different Alveolar Preservation Protocols in Posterior Regions: A Randomized Controlled Study";
- Patients with implants and healing abutments from Bionnovation Biomedical in place at the time of prosthetic rehabilitation;
- Implants without surrounding bone loss;
- Signed informed consent form.
Who cannot join
- Patients with uncontrolled systemic diseases;
- Pregnant or lactating women;
- Smokers or former smokers;
- Undergoing orthodontic treatment;
- Using medications that interfere with bone healing, such as those for osteoporosis and bisphosphonates;
- Implants with bone loss or failed implants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Piracicaba Dental School
Piracicaba, São Paulo, 13414903
About this study
Official title: Potential Influence of Pre-fabricated and Customized Anatomical Zirconia Abutments in the Peri-implant Region for Single-tooth Implant-supported Prosthetic Restorations
Objectives:
To compare the influence of pre-fabricated titanium abutments and customized milled zirconia abutments on implant biocompatibility and the peri-implant region, as well as on radiographic bone loss and oral health-related quality of life.
Read more
Detailed Methodology:
This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations. The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period. After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power. The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols. Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis, comprehensive periodontal clinical parameters, measurement of keratinized mucosa thickness, standardized periapical radiographs for marginal bone level assessment, and intraoral digital scanning for volumetric and soft tissue analysis. The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period. This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.
Read the detailed description
This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations.
The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period.
After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power.
The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols.
Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include:
Peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis Comprehensive periodontal clinical parameters Measurement of keratinized mucosa thickness Standardized periapical radiographs for marginal bone level assessment Intraoral digital scanning for volumetric and soft tissue analysis The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period.
This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.
- Being tested
- Pre-fabricated standardized titanium abutments, Customized anatomical zirconia abutments
- Keywords
- Dental Prosthesis, Connection, Dental Implant-Abutment, Dental Porcelain, Biofilm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-fabricated standardized titanium abutmentsDevice
Participants receive prosthetic rehabilitation with manufacturer-provided pre-fabricated standardized titanium abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures.
Customized anatomical zirconia abutmentsDevice
Participants receive prosthetic rehabilitation with CAD/CAM-fabricated customized anatomical zirconia abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures.
| Study group | Role | What they receive |
|---|---|---|
| TiB Group | Active comparator | Participants rehabilitated with pre-fabricated standardized titanium abutments supporting single zirconia crowns.
Intervention linked: Pre-fabricated standardized titanium abutments Receives: Device: Pre-fabricated standardized titanium abutments |
| ZiT Group | Experimental | Participants rehabilitated with customized anatomical zirconia abutments supporting single zirconia crowns.
Intervention linked: Customized anatomical zirconia abutments Receives: Device: Customized anatomical zirconia abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Colonization in Peri-implant Sites
Quantitative assessment of bacterial load in peri-implant crevicular fluid samples, expressed as CFU/ml, determined by qPCR analysis.
Measured: 1, 3, 6, and 12 months after prosthesis installation
Secondary outcomes (1)
Demographic Characteristics of the Study Population
Descriptive analysis of participant demographic variables, including age and sex, reported as means and frequency distribution.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start30 Apr 2025
- Primary completion30 May 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peri-Implant HealthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Casarin, University of Campinas, Brazil
- Investigators
- Renato Casarin, Associate Professor, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456163
- Sponsor's protocol ID
- 86486425.5.0000.5418
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations and privacy concerns, as the data contain sensitive personal health information that could potentially compromise participant confidentiality, even if anonymized. Additionally, no explicit consent for data sharing was obtained from participants during recruitment.
Publications
Bouri A Jr, Bissada N, Al-Zahrani MS, Faddoul F, Nouneh I. Width of keratinized gingiva and the health status of the supporting tissues around dental implants. Int J Oral Maxillofac Implants. 2008 Mar-Apr;23(2):323-6.
PubMed 18548930Koutouzis T. Implant-abutment connection as contributing factor to peri-implant diseases. Periodontol 2000. 2019 Oct;81(1):152-166. doi: 10.1111/prd.12289.
PubMed 31407436Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.
PubMed 4924041Kumar PS. Systemic Risk Factors for the Development of Periimplant Diseases. Implant Dent. 2019 Apr;28(2):115-119. doi: 10.1097/ID.0000000000000873.
PubMed 30893143Berglundh T, Lindhe J, Ericsson I, Marinello CP, Liljenberg B, Thomsen P. The soft tissue barrier at implants and teeth. Clin Oral Implants Res. 1991 Apr-Jun;2(2):81-90. doi: 10.1034/j.1600-0501.1991.020206.x.
PubMed 1809403Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
PubMed 18724855Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
PubMed 29926957Lang NP, Berglundh T; Working Group 4 of Seventh European Workshop on Periodontology. Periimplant diseases: where are we now?--Consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:178-81. doi: 10.1111/j.1600-051X.2010.01674.x.
PubMed 21323713
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Influence of Pre-fabricated and Customized Anatomical Zirconia Abutments in the Peri-implant Region for Single-tooth Implant-supported Prosthetic Restorations
- ClinicalTrials.gov ID
- NCT07456163
- Acronym / sponsor ID
- 86486425.5.0000.5418
- Keywords
- Dental Prosthesis, Connection, Dental Implant-Abutment, Dental Porcelain, Biofilm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
Objectives:
To compare the influence of pre-fabricated titanium abutments and customized milled zirconia abutments on implant biocompatibility and the peri-implant region, as well as on radiographic bone loss and oral health-related quality of life.
Detailed Methodology:
This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations. The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period. After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power. The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols. Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis, comprehensive periodontal clinical parameters, measurement of keratinized mucosa thickness, standardized periapical radiographs for marginal bone level assessment, and intraoral digital scanning for volumetric and soft tissue analysis. The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period. This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.
Detailed description
This study is a randomized controlled clinical trial designed to evaluate the biological and clinical behavior of standardized titanium abutments compared with customized anatomical zirconia abutments in single implant-supported posterior restorations.
The present investigation represents the prosthetic phase of a previously conducted randomized clinical trial that evaluated dimensional changes following different alveolar preservation protocols in posterior regions (CAAE: 59208422.8.0000.5418). In the previous phase, participants underwent tooth extraction and alveolar preservation procedures, followed by implant placement with Morse Taper (CM) implants (Biomorse XP, Bionnovation Biomedical) after a six-month healing period.
After implant osseointegration, participants eligible for prosthetic rehabilitation will be randomly allocated to one of two parallel groups using a computer-generated randomization sequence (Sealedenvelope.com). The allocation ratio will be 1:1. Sample size calculation was performed using GPower software to ensure adequate statistical power.
The intervention consists of prosthetic rehabilitation with either standardized titanium abutments (TiB group) or customized anatomical zirconia abutments (ZiT group), both supporting single zirconia crowns in posterior regions. All prosthetic and laboratory procedures will follow standardized clinical protocols.
Clinical and laboratory assessments will be conducted at prosthesis delivery (baseline) and at 1-, 3-, 6-, and 12-month follow-up visits. Data collection will include:
Peri-implant crevicular fluid (PICF) and biofilm sampling for biomolecular analysis Comprehensive periodontal clinical parameters Measurement of keratinized mucosa thickness Standardized periapical radiographs for marginal bone level assessment Intraoral digital scanning for volumetric and soft tissue analysis The primary objective is to compare peri-implant tissue stability and biological response between titanium and zirconia abutments. Secondary outcomes include clinical parameters, marginal bone level changes, and soft tissue dimensional stability over a 12-month follow-up period.
This study aims to contribute to the understanding of how abutment material and design may influence peri-implant health and long-term tissue stability in posterior implant-supported restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TiB Group | Active comparator | Device: Pre-fabricated standardized titanium abutmentsParticipants rehabilitated with pre-fabricated standardized titanium abutments supporting single zirconia crowns. Intervention linked: Pre-fabricated standardized titanium abutments |
| ZiT Group | Experimental | Device: Customized anatomical zirconia abutmentsParticipants rehabilitated with customized anatomical zirconia abutments supporting single zirconia crowns. Intervention linked: Customized anatomical zirconia abutments |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18 years or older;
- Participants in the Master's Thesis entitled: "Dimensional Changes Following Different Alveolar Preservation Protocols in Posterior Regions: A Randomized Controlled Study";
- Patients with implants and healing abutments from Bionnovation Biomedical in place at the time of prosthetic rehabilitation;
- Implants without surrounding bone loss;
- Signed informed consent form.
Key exclusion criteria (6 listed)
- Patients with uncontrolled systemic diseases;
- Pregnant or lactating women;
- Smokers or former smokers;
- Undergoing orthodontic treatment;
- Using medications that interfere with bone healing, such as those for osteoporosis and bisphosphonates;
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 |
|---|---|---|
| Pre-fabricated standardized titanium abutmentsParticipants receive prosthetic rehabilitation with manufacturer-provided pre-fabricated standardized titanium abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures. | Device | TiB Group |
| Customized anatomical zirconia abutmentsParticipants receive prosthetic rehabilitation with CAD/CAM-fabricated customized anatomical zirconia abutments connected to previously osseointegrated Morse Taper implants. After abutment placement, single zirconia crowns are installed following standardized digital prosthetic procedures. | Device | ZiT Group |
Primary outcome
Microbial Colonization in Peri-implant Sites
Time frame: 1, 3, 6, and 12 months after prosthesis installation
Quantitative assessment of bacterial load in peri-implant crevicular fluid samples, expressed as CFU/ml, determined by qPCR analysis.
1 secondary outcome
Demographic Characteristics of the Study Population
Time frame: Baseline
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 17 Mar 2026.
- Results publication: PubMed 18548930Bouri A Jr, Bissada N, Al-Zahrani MS, Faddoul F, Nouneh I. Width of keratinized gingiva and the health status of the supporting tissues around dental implants. Int J Oral Maxillofac Implants. 2008 Mar-Apr;23(2):323-6.
- Results publication: PubMed 31407436Koutouzis T. Implant-abutment connection as contributing factor to peri-implant diseases. Periodontol 2000. 2019 Oct;81(1):152-166. doi: 10.1111/prd.12289.
- Results publication: PubMed 4924041Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.
- Results publication: PubMed 30893143Kumar PS. Systemic Risk Factors for the Development of Periimplant Diseases. Implant Dent. 2019 Apr;28(2):115-119. doi: 10.1097/ID.0000000000000873.
- Results publication: PubMed 1809403Berglundh T, Lindhe J, Ericsson I, Marinello CP, Liljenberg B, Thomsen P. The soft tissue barrier at implants and teeth. Clin Oral Implants Res. 1991 Apr-Jun;2(2):81-90. doi: 10.1034/j.1600-0501.1991.020206.x.
- Results publication: PubMed 18724855Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
- Results publication: PubMed 29926957Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
- Results publication: PubMed 21323713Lang NP, Berglundh T; Working Group 4 of Seventh European Workshop on Periodontology. Periimplant diseases: where are we now?--Consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:178-81. doi: 10.1111/j.1600-051X.2010.01674.x.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations and privacy concerns, as the data contain sensitive personal health information that could potentially compromise participant confidentiality, even if anonymized. Additionally, no explicit consent for data sharing was obtained from participants during recruitment.
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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.
Renato Casarin, Associate Professor principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-fabricated standardized titanium abutments and Customized anatomical zirconia abutments in people with Peri-Implant Health and Implant Complication, run by University of Campinas, Brazil 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 5 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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?
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 Leticia Sandoli Arroteia, Ms and PhD Student (+5514981600821, leticia.sandoli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Colonization in Peri-implant Sites (time frame: 1, 3, 6, and 12 months after prosthesis installation). 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 NCT07456163, which also lists 8 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 17 Mar 2026.