Jaw, Edentulous, PartiallyNCT03059108
Evaluation of B+ Surface on Early Loading
A study testing Early Loading and Conventional Loading in people with Jaw, Edentulous, Partially, run by Universidad de Granada at 1 site in Spain.
Trial summary
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Early Loading and Conventional Loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2017to 14 Apr 2020
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient >18 and ≤75 years old
- One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
Who cannot join
- One-stage bone augmentation
- Heavy smokers (>10 cigarettes/day)
- Uncontrolled type 1 or 2 diabetes (HgA1c>8)
- Known auto-immune or inflammatory disease
- Severe hematologic disorders, such as hemophilia or leukemia
- Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)
Show all 14Show fewer
- Liver or kidney dysfunction/failure
- Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy
- Long-term history of oral bisphosphonates use (i.e., 10 years or more)
- History of intravenous bisphosphonates
- Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system
- Severe osseous diseases (e.g., Paget disease of bone)
- Pregnant women or nursing mothers
- Not able or not willing to follow instructions related to the study procedures
Trial locations and contacts
1 site in 1 country.
About this study
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Early Loading, Conventional Loading
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early LoadingProcedure or surgery
The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.
Conventional LoadingProcedure or surgery
The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Early Loading | Experimental | Implant early loading: prosthesis delivery 4 weeks after implant placement Receives: Procedure: Early Loading |
| Conventional Loading | Active comparator | Implant conventional loading: prosthesis delivery 8 weeks after implant placement Receives: Procedure: Conventional Loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007
Measured: 12 months
Secondary outcomes (3)
Change in marginal bone level around B+-treated implants after conventional or early loading protocol
Measured: 0 (Baseline: prosthesis delivery), 3, 6, and 12 months
Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol
Measured: -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months
Change in the microbiological profile around B+-treated implants after conventional or early loading protocol
Measured: -14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start20 Feb 2017
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Galindo-Moreno, Universidad de Granada
- Investigators
- Pablo Galindo-Moreno, DDS, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059108
- Sponsor's protocol ID
- 216CEIH2016
- Status last verified
- May 2023
- First submitted
- 12 Feb 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Galindo-Moreno P, Gutierrez-Garrido L, Lopez-Chaichio L, Guerra-Lorenzo C, Rodriguez-Alvarez R, Padial-Molina M. Crestal bone changes around early vs. conventionally loaded implants with a multi-phosphonate coated surface: A randomized pilot clinical trial. Clin Oral Implants Res. 2021 Jan;32(1):75-87. doi: 10.1111/clr.13681. Epub 2020 Dec 18.
PubMed 33210771Galindo-Moreno P, Gutierrez-Garrido L, Duarte J, Robles-Vera I, Martin-Morales N, O'Valle F, Olaechea A, Carrillo-Galvez AB, Padial-Molina M. Evolution in the Peri-Implant Oral Microbiome and Their Relationship to Long-Term Marginal Bone Loss: A Randomized Clinical Study. Clin Oral Implants Res. 2025 Jul;36(7):802-820. doi: 10.1111/clr.14426. Epub 2025 Mar 10.
PubMed 40062725
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of B+ Surface on Early Loading
- ClinicalTrials.gov ID
- NCT03059108
- Acronym / sponsor ID
- 216CEIH2016
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 23 Feb 2017 (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 trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Loading | Experimental | Procedure: Early LoadingImplant early loading: prosthesis delivery 4 weeks after implant placement |
| Conventional Loading | Active comparator | Procedure: Conventional LoadingImplant conventional loading: prosthesis delivery 8 weeks after implant placement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient >18 and ≤75 years old
- One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
Key exclusion criteria (14 listed)
- One-stage bone augmentation
- Heavy smokers (>10 cigarettes/day)
- Uncontrolled type 1 or 2 diabetes (HgA1c>8)
- Known auto-immune or inflammatory disease
- Severe hematologic disorders, such as hemophilia or leukemia
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 |
|---|---|---|
| Early LoadingThe procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups. | Procedure or surgery | Early Loading |
| Conventional LoadingThe procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups. | Procedure or surgery | Conventional Loading |
Primary outcome
Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007
Time frame: 12 months
3 secondary outcomes
Change in marginal bone level around B+-treated implants after conventional or early loading protocol
Time frame: 0 (Baseline: prosthesis delivery), 3, 6, and 12 months
Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol
Time frame: -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months
Change in the microbiological profile around B+-treated implants after conventional or early loading protocol
Time frame: -14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months
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 23 May 2023.
- Results publication: PubMed 33210771Galindo-Moreno P, Gutierrez-Garrido L, Lopez-Chaichio L, Guerra-Lorenzo C, Rodriguez-Alvarez R, Padial-Molina M. Crestal bone changes around early vs. conventionally loaded implants with a multi-phosphonate coated surface: A randomized pilot clinical trial. Clin Oral Implants Res. 2021 Jan;32(1):75-87. doi: 10.1111/clr.13681. Epub 2020 Dec 18.
- Derived from this study: PubMed 40062725Galindo-Moreno P, Gutierrez-Garrido L, Duarte J, Robles-Vera I, Martin-Morales N, O'Valle F, Olaechea A, Carrillo-Galvez AB, Padial-Molina M. Evolution in the Peri-Implant Oral Microbiome and Their Relationship to Long-Term Marginal Bone Loss: A Randomized Clinical Study. Clin Oral Implants Res. 2025 Jul;36(7):802-820. doi: 10.1111/clr.14426. Epub 2025 Mar 10.
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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.
Pablo Galindo-Moreno, DDS, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Loading and Conventional Loading in people with Jaw, Edentulous, Partially, run by Universidad de Granada at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 23 May 2023. 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 Spain. 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?
Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007 (time frame: 12 months). 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 NCT03059108, which also lists 2 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 23 May 2023.