Implant-supported Single CrownsNCT07897487
Influence of Prosthetic Characteristics of Implant-Supported Crowns on Peri-implant Health and Osseointegration: A Comparison Between Digital and Conventional Workflows
An observational study of Implant-supported Single Crowns and Osseointegration, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial summary
The objective of this prospective cohort study is to evaluate marginal bone loss and peri-implant health in patients with single dental implants requiring prosthetic rehabilitation, comparing conventional and digital methods for fabricating implant-supported crowns over a 24-month period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant-supported Single Crowns, Osseointegration, Peri-Implant Health
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2024to 18 Dec 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated at the undergraduate and postgraduate clinics of the Faculty of Dentistry, School of Health and Life Sciences, at the Pontifical Catholic University of Rio Grande do Sul.
Who may be able to join
- Partially edentulous patients indicated for rehabilitation with single, partial, or multiple implant-supported prostheses.
- Patients over 18 years of age.
- Individuals who are periodontally healthy regarding their remaining teeth and other implants.
- Individuals with a healthy, restored, or rehabilitated homologous tooth (on the contralateral side) that features a tooth-supported fixed prosthesis with a satisfactory shape and color in relation to the adjacent teeth.
- Individuals with a balanced occlusion and no pathological signs affecting their remaining teeth or existing prostheses.
- Individuals who have a provisional restoration on the implant or for whom a provisional restoration is planned prior to the fabrication of the definitive crown.
Who cannot join
- Individuals requiring prior orthodontic treatment or extensive oral rehabilitation.
- Patients with a history of implant rehabilitation involving extensive alveolar ridge reconstruction.
- Short or narrow implants (<3.3 mm).
- Patients with uncontrolled diabetes.
- Patients undergoing radiotherapy or chemotherapy.
- Heavy smokers (>10 cigarettes per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of the Influence of Prosthetic Characteristics of Implant-supported Single Crowns Manufactured Digitally and Conventionally on Peri-implant Health and Osseointegration
The objective of this prospective cohort study is to evaluate marginal bone loss and peri-implant health in patients with single dental implants requiring prosthetic rehabilitation, comparing conventional and digital methods for fabricating implant-supported crowns over a 24-month period.
The primary questions the study aims to answer are:
Read more
Are there differences in marginal bone loss between implant-supported crown rehabilitations fabricated using conventional versus digital workflows?
Are the prosthetic fabrication methodology, crown design, and abutment characteristics associated with differences in peri-implant health and outcomes related to osseointegration?
How do peri-implant clinical parameters and marginal bone loss relate to the patients' oral health-related quality of life?
The researchers will follow two groups of patients: one undergoing prosthetic rehabilitation via conventional impression-taking, and the other via digital scanning. The projected sample size is 32 patients, with 16 in each group.
Read the detailed description
Dental implants are widely used in oral rehabilitation; however, their long-term success depends on the stability of the implant-prosthesis system and the maintenance of the health of the surrounding tissues. Biological complications, such as peri-implant mucositis and peri-implantitis, can compromise both soft tissues and the supporting bone. In addition to biofilm accumulation, factors related to the prosthetic configuration, the fit of the components, and the emergence profile of the crowns can influence local conditions and the feasibility of oral hygiene maintenance.
The development of digital technologies-including intraoral scanning and computer-aided design and computer-aided manufacturing (CAD/CAM) systems-has expanded the possibilities for planning and fabricating implant-supported restorations. Nevertheless, it remains to be clarified whether these technologies are associated with superior clinical and biological outcomes compared to conventional methods.
Study Design and Population
This study employs a prospective cohort design and will be conducted at the School of Dentistry of the Pontifical Catholic University of Rio Grande do Sul (PUCRS) in Porto Alegre, Brazil.
The projected sample will consist of 32 patients who already have single dental implants in place and require implant-supported restorations. Eligible patients who agree to participate will be enrolled upon signing an Informed Consent Form.
Participants will be monitored across two groups, defined according to the method used to fabricate the prosthetic rehabilitation:
Conventional Group: Prosthetic rehabilitation planned and executed via conventional impression techniques, utilizing impression copings, addition-cured silicone, dental stone casts, and standard prosthetic fabrication procedures.
Digital Group: Prosthetic rehabilitation planned and executed via intraoral scanning and digital data processing for the fabrication of the implant-supported restoration. Sixteen patients will be included in each group. To standardize the fabrication of the restorations, the study design specifies the use of the same dental laboratory and the same operator for the creation of the crowns.
Assessments and procedures
Participants will undergo a medical history interview (anamnesis), collection of sociodemographic data, clinical assessment of remaining teeth and implants, a peri-implant examination (periogram), photographic documentation of the crowns, and an evaluation of oral health-related quality of life using the Oral Health Impact Profile (OHIP-14) questionnaire.
Clinical assessments will be conducted at five time points: at the time of definitive crown placement (T0) and at 6 months (T1), 12 months (T2), 18 months (T3), and 24 months (T4) post-placement. Examinations will be performed by trained and calibrated examiners, following the procedures outlined in the protocol.
Peri-implant clinical parameters will include:
Bleeding on probing and the presence or absence of suppuration.
Modified plaque index.
Probing depth and marginal recession.
Height of the keratinized mucosa and gingival thickness.
Sulcular bleeding index and gingival phenotype.
Mucosal emergence angle and characteristics of the prosthetic emergence profile.
Radiographic assessment will be used to measure the marginal bone level around the implants. Digital periapical radiographs will be taken using the paralleling technique with customized positioning devices; measurements will be performed using image-processing software, based on anatomical landmarks of the implant and the bone-implant interface.
Data regarding the characteristics of the implants and restorations will also be recorded, including location, implant dimensions, platform and connection type, angulation of the prosthetic component, type of retention, presence of prosthetic misfit, timing of loading, material and characteristics of the abutments, and the method used for transferring the implant position.
Statistical analysis will be performed comparing the groups.
- Keywords
- Osseointegration, Peri-implant Health, Implant-supported fixed prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 conventional | Group in which implant-supported crowns were rehabilitated using a conventional workflow. | |
| Group 2 - digital | Group in which implant-supported crowns were rehabilitated using a digital workflow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant bone loss
Peri-implant bone loss measured by digital periapical X-rays. Comparing the bone level around the implants at pre-specified time points.
Measured: From the enrollment to the end of the study - 0 days to 24 months.
Secondary outcomes (2)
Peri-implant health
Investigation of peri-implant health around the rehabilitated implants comparing:
Bleeding on probing and the presence or absence of suppuration.
Modified plaque index.
Probing depth and marginal recession.
Height of the keratinized mucosa and gingival thickness.
Sulcular bleeding index and gingival phenotype.
Measured: From the enrollment to the end of the study - 0 days to 24 months.
Patient satisfaction
Investigation of patient satisfaction using patient-reported outcomes (PROMs) - OHIP-49 (Oral Health Impact Profile) questionnaire.
A score from 0 to 4 is assigned to each question. 0 is the best outcome, and 4 is the worst outcome.
Measured: From the enrollment to the end of the study - 0 days to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jul 2024
- Primary completion5 May 2025
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant-supported Single CrownsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcel Ferreira Kunrath, Pontificia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897487
- Sponsor's protocol ID
- 88887.964361/2024-00
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Influence of Prosthetic Characteristics of Implant-supported Single Crowns Manufactured Digitally and Conventionally on Peri-implant Health and Osseointegration
- ClinicalTrials.gov ID
- NCT07897487
- Acronym / sponsor ID
- 88887.964361/2024-00
- Keywords
- Osseointegration, Peri-implant Health, Implant-supported fixed prosthesis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 27 Oct 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.
The objective of this prospective cohort study is to evaluate marginal bone loss and peri-implant health in patients with single dental implants requiring prosthetic rehabilitation, comparing conventional and digital methods for fabricating implant-supported crowns over a 24-month period.
The primary questions the study aims to answer are:
Are there differences in marginal bone loss between implant-supported crown rehabilitations fabricated using conventional versus digital workflows?
Are the prosthetic fabrication methodology, crown design, and abutment characteristics associated with differences in peri-implant health and outcomes related to osseointegration?
How do peri-implant clinical parameters and marginal bone loss relate to the patients' oral health-related quality of life?
The researchers will follow two groups of patients: one undergoing prosthetic rehabilitation via conventional impression-taking, and the other via digital scanning. The projected sample size is 32 patients, with 16 in each group.
Detailed description
Dental implants are widely used in oral rehabilitation; however, their long-term success depends on the stability of the implant-prosthesis system and the maintenance of the health of the surrounding tissues. Biological complications, such as peri-implant mucositis and peri-implantitis, can compromise both soft tissues and the supporting bone. In addition to biofilm accumulation, factors related to the prosthetic configuration, the fit of the components, and the emergence profile of the crowns can influence local conditions and the feasibility of oral hygiene maintenance.
The development of digital technologies-including intraoral scanning and computer-aided design and computer-aided manufacturing (CAD/CAM) systems-has expanded the possibilities for planning and fabricating implant-supported restorations. Nevertheless, it remains to be clarified whether these technologies are associated with superior clinical and biological outcomes compared to conventional methods.
Study Design and Population
This study employs a prospective cohort design and will be conducted at the School of Dentistry of the Pontifical Catholic University of Rio Grande do Sul (PUCRS) in Porto Alegre, Brazil.
The projected sample will consist of 32 patients who already have single dental implants in place and require implant-supported restorations. Eligible patients who agree to participate will be enrolled upon signing an Informed Consent Form.
Participants will be monitored across two groups, defined according to the method used to fabricate the prosthetic rehabilitation:
Conventional Group: Prosthetic rehabilitation planned and executed via conventional impression techniques, utilizing impression copings, addition-cured silicone, dental stone casts, and standard prosthetic fabrication procedures.
Digital Group: Prosthetic rehabilitation planned and executed via intraoral scanning and digital data processing for the fabrication of the implant-supported restoration. Sixteen patients will be included in each group. To standardize the fabrication of the restorations, the study design specifies the use of the same dental laboratory and the same operator for the creation of the crowns.
Assessments and procedures
Participants will undergo a medical history interview (anamnesis), collection of sociodemographic data, clinical assessment of remaining teeth and implants, a peri-implant examination (periogram), photographic documentation of the crowns, and an evaluation of oral health-related quality of life using the Oral Health Impact Profile (OHIP-14) questionnaire.
Clinical assessments will be conducted at five time points: at the time of definitive crown placement (T0) and at 6 months (T1), 12 months (T2), 18 months (T3), and 24 months (T4) post-placement. Examinations will be performed by trained and calibrated examiners, following the procedures outlined in the protocol.
Peri-implant clinical parameters will include:
Bleeding on probing and the presence or absence of suppuration.
Modified plaque index.
Probing depth and marginal recession.
Height of the keratinized mucosa and gingival thickness.
Sulcular bleeding index and gingival phenotype.
Mucosal emergence angle and characteristics of the prosthetic emergence profile.
Radiographic assessment will be used to measure the marginal bone level around the implants. Digital periapical radiographs will be taken using the paralleling technique with customized positioning devices; measurements will be performed using image-processing software, based on anatomical landmarks of the implant and the bone-implant interface.
Data regarding the characteristics of the implants and restorations will also be recorded, including location, implant dimensions, platform and connection type, angulation of the prosthetic component, type of retention, presence of prosthetic misfit, timing of loading, material and characteristics of the abutments, and the method used for transferring the implant position.
Statistical analysis will be performed comparing the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 conventional | – | –Group in which implant-supported crowns were rehabilitated using a conventional workflow. |
| Group 2 - digital | – | –Group in which implant-supported crowns were rehabilitated using a digital workflow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the undergraduate and postgraduate clinics of the Faculty of Dentistry, School of Health and Life Sciences, at the Pontifical Catholic University of Rio Grande do Sul.
Key inclusion criteria (6 listed)
- Partially edentulous patients indicated for rehabilitation with single, partial, or multiple implant-supported prostheses.
- Patients over 18 years of age.
- Individuals who are periodontally healthy regarding their remaining teeth and other implants.
- Individuals with a healthy, restored, or rehabilitated homologous tooth (on the contralateral side) that features a tooth-supported fixed prosthesis with a satisfactory shape and color in relation to the adjacent teeth.
- Individuals with a balanced occlusion and no pathological signs affecting their remaining teeth or existing prostheses.
Key exclusion criteria (6 listed)
- Individuals requiring prior orthodontic treatment or extensive oral rehabilitation.
- Patients with a history of implant rehabilitation involving extensive alveolar ridge reconstruction.
- Short or narrow implants (<3.3 mm).
- Patients with uncontrolled diabetes.
- Patients undergoing radiotherapy or chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peri-implant bone loss
Time frame: From the enrollment to the end of the study - 0 days to 24 months.
Peri-implant bone loss measured by digital periapical X-rays. Comparing the bone level around the implants at pre-specified time points.
2 secondary outcomes
Peri-implant health
Time frame: From the enrollment to the end of the study - 0 days to 24 months.
Patient satisfaction
Time frame: From the enrollment to the end of the study - 0 days to 24 months.
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 30 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant-supported Single Crowns and Osseointegration, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 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?
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?
Peri-implant bone loss (time frame: From the enrollment to the end of the study - 0 days to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.