Dental ImplantsNCT05627037
Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture
A study testing Dental implant produced by additive manufacture in people with Dental Implants, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental implant produced by additive manufacture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Nov 2022to 2 Nov 2025
- 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
- Patients treated and referred by the Dental Clinic of the School of Dentistry of the University of São Paulo;
- Individuals over 18 years and under 70 years of age;
- Good general health;
- signed Informed Consent Form;
- Need for rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars);
- bacterial plaque index ≤ 20% (Silness \& Loe, 1964);
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- bleeding rate of ≤ 20% (Loe \& Silness, 1963);
- Sufficient alveolar bone volume for an implant of:
- Length: 8 or 10mm
- Diameter: 3.5mm, 4. 00mm or 4. 5mm
- Bone quality type I-III;
- No associated bone regeneration.
Who cannot join
- Pregnant and lactating women;
- Uncontrolled diabetes;
- History of chemotherapy or radiotherapy in the last 5 years;
- Radiotherapy in areas of the head and neck;
- Use of immunosuppressants, bisphosphonate or prolonged use of corticosteroids;
- Smokers;
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- Alcohol or drug abuse;
- Untreated periodontitis;
- History of previous bone increase in the implant installation region;
- Presence of residual roots at the site receiving the implant;
- Bone density type IV
- Individuals with connective tissue disorders or metabolic diseases;
- Postmenopausal osteoporosis or other systemic diseases that may affect bone metabolism;
- Need for guided bone regeneration at the time of implant installation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry - University of São Paulo
São Paulo, 05508-900
About this study
Official title: Evaluation of the Marginal Bone Level of Titanium Implants Produced by Additive Manufacture, in 30 and 90 Days: Randomized Within-subject Clinical Trial of 1-year Non-inferiority
The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up
Read the detailed description
This randomized Split-mouth clinical study of non-inferiority will monitor for one year partially edentulous patients in the posterior region of the mandible or maxilla, rehabilitated with 2 implants (AM) in the same Arch to evaluate the success rate of the implant, one loaded at 30 days after installation and the other at 90 days. Changes in marginal bone level and osseointegration success will be evaluated, with visits and data collection in 0 days (baseline), 30 days, 90 days, 6 months and 1 year
- Conditions
- Dental Implants
- Being tested
- Dental implant produced by additive manufacture
- Keywords
- implant, osseointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant produced by additive manufactureDevice
In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will be randomly allocated to receive Temporary restoration after 30 days and definitive restoration after 90 days
Dental implant produced by additive manufactureDevice
In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will receive definitive restoration after 90 days
| Study group | Role | What they receive |
|---|---|---|
| Loading in 30 days | Experimental | Implant allocated to the study arm will be restored with a temporary restoration after 30 days of implant placement, that will be replaced with definitive restoration after 90 days of implant placement. Receives: Device: Dental implant produced by additive manufacture |
| Loading in 90 days | Active comparator | Implant allocated to the study arm will be restored directly with the definitive restoration after 90 days of implant placement. Receives: Device: Dental implant produced by additive manufacture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss (MBL)
Digital periapical radiographs will be taken at the implant installation (baseline) after 1 year. The radiographs will be taken using the parallelism technique with a positioner that supports the digital sensor in order to standardize the radiographs.
Measured: 1 year
Secondary outcomes (5)
Implant success rate
The success rate or failure of each implant in clinical and radiographic findings will be classified using the success criteria defined by Buser et al. (1990)
- Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysesthesia.
- Absence of a recurrent peri-implant infection with suppuration.
- Absence of mobility.
- Absence of a continuous radiolucency around the implant.
- Possibility for restoration. These criteria will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Measured: 1 year
Modified Plaque Index (mPI)
Modified Plaque Index (Mombelli, Van Oosten Et.Al 1987):
Scoring Criteria:
Score 0: No detection of plaque Score 1:Plaque only recognized by running a probe across the smooth marginal surface of the implant Score 2: Plaque can be seen by the naked eye. Score 3: Abundance of soft matter. The changes in Modified Plaque Index (mPI) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Measured: 1 year
Modified Bleeding Index (mBI)
Modified Sulcus Bleeding Index (Mombelli, Van Oosten Et.Al 1987):
Scoring Criteria:
Score 0: No bleeding when probe is passed along the gingival margin. Score 1: Isolated bleeding, spots present. Score 2: Blood forms a confluent red line on margins. Score 3: Heavy or profuse bleeding. The changes in Modified Bleeding Index (mBI) will be monitored by a blinded calibrated examiner at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Measured: 1 year
Pocket probing depth (PPD)
Pocket Probing Depth (PPD) will be measured by a blinded calibrated Examiner, and The changes in Pocket Probing Depth (PPD) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Measured: 1 year
clinical attachment level (CAL)
Clinical attachment level (CAL) will be measured by a blinded calibrated Examiner, and The changes in clinical attachment level (CAL) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start2 Nov 2022
- Primary completion2 Nov 2023
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Model description
- Split-Mouth Study Model
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Plenum (M3 Health Industria e Comercio de Produtos Médicos)
- Responsible party
- Principal investigator, Giuseppe Alexandre Romito, University of Sao Paulo
- Investigators
- Giuseppe A Romito, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627037
- Sponsor's protocol ID
- 59844422.4.0000.0075
- Status last verified
- Jun 2025
- First submitted
- 31 Oct 2022
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Marginal Bone Level of Titanium Implants Produced by Additive Manufacture, in 30 and 90 Days: Randomized Within-subject Clinical Trial of 1-year Non-inferiority
- ClinicalTrials.gov ID
- NCT05627037
- Acronym / sponsor ID
- 59844422.4.0000.0075
- Conditions
- Dental Implants
- Keywords
- implant, osseointegration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Plenum (M3 Health Industria e Comercio de Produtos Médicos)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 25 Nov 2022 (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 will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up
Detailed description
This randomized Split-mouth clinical study of non-inferiority will monitor for one year partially edentulous patients in the posterior region of the mandible or maxilla, rehabilitated with 2 implants (AM) in the same Arch to evaluate the success rate of the implant, one loaded at 30 days after installation and the other at 90 days. Changes in marginal bone level and osseointegration success will be evaluated, with visits and data collection in 0 days (baseline), 30 days, 90 days, 6 months and 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Mouth Study Model
| Arm | Type | Receives |
|---|---|---|
| Loading in 30 days | Experimental | Device: Dental implant produced by additive manufactureImplant allocated to the study arm will be restored with a temporary restoration after 30 days of implant placement, that will be replaced with definitive restoration after 90 days of implant placement. |
| Loading in 90 days | Active comparator | Device: Dental implant produced by additive manufactureImplant allocated to the study arm will be restored directly with the definitive restoration after 90 days of implant placement. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients treated and referred by the Dental Clinic of the School of Dentistry of the University of São Paulo;
- Individuals over 18 years and under 70 years of age;
- Good general health;
- signed Informed Consent Form;
- Need for rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars);
Key exclusion criteria (14 listed)
- Pregnant and lactating women;
- Uncontrolled diabetes;
- History of chemotherapy or radiotherapy in the last 5 years;
- Radiotherapy in areas of the head and neck;
- Use of immunosuppressants, bisphosphonate or prolonged use of corticosteroids;
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 |
|---|---|---|
| Dental implant produced by additive manufactureIn a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will be randomly allocated to receive Temporary restoration after 30 days and definitive restoration after 90 days | Device | Loading in 30 days |
| Dental implant produced by additive manufactureIn a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will receive definitive restoration after 90 days | Device | Loading in 90 days |
Primary outcome
Marginal Bone Loss (MBL)
Time frame: 1 year
Digital periapical radiographs will be taken at the implant installation (baseline) after 1 year. The radiographs will be taken using the parallelism technique with a positioner that supports the digital sensor in order to standardize the radiographs.
5 secondary outcomes
Implant success rate
Time frame: 1 year
Modified Plaque Index (mPI)
Time frame: 1 year
Modified Bleeding Index (mBI)
Time frame: 1 year
Pocket probing depth (PPD)
Time frame: 1 year
clinical attachment level (CAL)
Time frame: 1 year
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 19 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Giuseppe A Romito, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant produced by additive manufacture in people with Dental Implants, run by University of Sao Paulo 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 12 inclusion and 14 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 19 Jun 2025. 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?
Marginal Bone Loss (MBL) (time frame: 1 year). 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 19 Jun 2025.