Bone Loss in JawNCT05668494
Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment
A study testing immediate loading of implants in people with Bone Loss in Jaw, run by University of Belgrade at 1 site in Serbia.
Trial summary
This will be a prospective, randomized, controlled, single center clinical trial with 1 year enrollment period, surgical and prosthetic rehabilitation with 1-year post-loading follow-up. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw
- What is being tested?
- immediate loading of implants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Sep 2022to 1 Sep 2024
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Minimum age of 25 years
- In need of a one or two implants.
- Healed site (healed site defined by restored gingiva, free of inflammation and scar tissue , with a keratinized band of 3mm from crest to muco-gingival junction, and sufficient osseous architecture to receive an implant with a minimal diameter of 3.5 mm).
- Mandible second premolar or molar region.
- At least one neighboring tooth to be present.
- Absence of visible active periapical or periodontal inflammation.
- Adequate oral hygiene: PI< 20%, BoP< 20%.
- Sufficient occlusal units mesial or distal and antagonizing, including the diastema to be restored: 4 occlusal units.
Who cannot join
- Medical condition that contraindicates surgery: ASA -score ≥ III
- History of radiotherapy in the head and neck region.
- History of Bisphosphonate medication.
- Medium smokers ≥ 10 cigarettes per day.
- Patients unwilling or incapable of understanding and signing the informed consent.
- Active caries.
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- Presence of inflammation expressed by PPD >4mm and BoP on adjacent teeth.
- Active periapical radiolucency or root canal treatment performed < 4 months previous to planned implant insertion on a neighboring tooth to future implant.
- Insufficient restorative space.
- Interocclusal plane distance < 20mm at planed implant position.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment in the Posterior Mandible Without Bone Augmentation
This will be a prospective, randomized, controlled, single center clinical trial with
1 year enrollment period, surgical and prosthetic rehabilitation with 1-year post-loading follow-up. A total of 2.0 years of study duration The primary objective is to compare peri-implant hard and soft tissue changes between single implants placed in the posterior mandible and immediately loaded either with definitive (one-time) or provisional abutment.
Read the detailed description
Hard tissue contour changes will be assessed using standardized two-dimensional intra-oral radiographs and partial small field of view three-dimensional cone beam CT scans. Soft tissue contour changes will be assessed using superimposition of dental digital models. Inflammatory soft tissue reactions will be evaluated by measurement of respective cytokines' levels.A quantitative evaluation of total bacteria amount of the peri-implant samples.
Secondary objectives of this study will be to estimate total bacterial amount (quantitative real-time polymerase chain reaction - qRT-PCR).
Bleeding on probing (BoP), full mouth oral hygiene index, periodontal pocket depth (PPD) and keratinized tissue width will also be evaluated.
Indication: Patients with need of at least two implants (one per side) in the premolar or molar region in the mandible, bilaterally.
- Conditions
- Bone Loss in Jaw
- Being tested
- immediate loading of implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate loading of implantsOther
This is a randomized control clinical trial including 24 implants, immediately loaded with definitive abutment protocol and 24 implants immediately loaded with with temporary abutment protocol
| Study group | Role | What they receive |
|---|---|---|
| immediate loading | Other | Immediate loading of implants by means of one definitive abutment on one side and temporary abutment on the other side of the posterior mandible restored by provisional crown-split mouth design Receives: Other: immediate loading of implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periimplant marginal bone loss
Hard tissue changes will be analyzed and followed up at 3, 6 and 12 months by captured intraoral radiographs using a customized radiographic holder. The following landmarks will be measured in order to assess bone remodelling around implants
- Mesial distance in mm from first bone to implant contact to implant shoulder (vertical line);
- Distal distance in mm from first bone to implant contact to implant shoulder (vertical line) after implant placement.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss in JawStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Todorovic, University of Belgrade
- Investigators
- Ana R Todorovic, DDS,PhD, Principal investigator, School of Dentistry, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668494
- Sponsor's protocol ID
- One abutment one time study
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment in the Posterior Mandible Without Bone Augmentation
- ClinicalTrials.gov ID
- NCT05668494
- Acronym / sponsor ID
- One abutment one time study
- Conditions
- Bone Loss in Jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 29 Dec 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.
This will be a prospective, randomized, controlled, single center clinical trial with
1 year enrollment period, surgical and prosthetic rehabilitation with 1-year post-loading follow-up. A total of 2.0 years of study duration The primary objective is to compare peri-implant hard and soft tissue changes between single implants placed in the posterior mandible and immediately loaded either with definitive (one-time) or provisional abutment.
Detailed description
Hard tissue contour changes will be assessed using standardized two-dimensional intra-oral radiographs and partial small field of view three-dimensional cone beam CT scans. Soft tissue contour changes will be assessed using superimposition of dental digital models. Inflammatory soft tissue reactions will be evaluated by measurement of respective cytokines' levels.A quantitative evaluation of total bacteria amount of the peri-implant samples.
Secondary objectives of this study will be to estimate total bacterial amount (quantitative real-time polymerase chain reaction - qRT-PCR).
Bleeding on probing (BoP), full mouth oral hygiene index, periodontal pocket depth (PPD) and keratinized tissue width will also be evaluated.
Indication: Patients with need of at least two implants (one per side) in the premolar or molar region in the mandible, bilaterally.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate loading | Other | Other: immediate loading of implantsImmediate loading of implants by means of one definitive abutment on one side and temporary abutment on the other side of the posterior mandible restored by provisional crown-split mouth design |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Minimum age of 25 years
- In need of a one or two implants.
- Healed site (healed site defined by restored gingiva, free of inflammation and scar tissue , with a keratinized band of 3mm from crest to muco-gingival junction, and sufficient osseous architecture to receive an implant with a minimal diameter of 3.5 mm).
- Mandible second premolar or molar region.
- At least one neighboring tooth to be present.
Key exclusion criteria (10 listed)
- Medical condition that contraindicates surgery: ASA -score ≥ III
- History of radiotherapy in the head and neck region.
- History of Bisphosphonate medication.
- Medium smokers ≥ 10 cigarettes per day.
- Patients unwilling or incapable of understanding and signing the informed consent.
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 |
|---|---|---|
| immediate loading of implantsThis is a randomized control clinical trial including 24 implants, immediately loaded with definitive abutment protocol and 24 implants immediately loaded with with temporary abutment protocol | Other | immediate loading |
Primary outcome
Periimplant marginal bone loss
Time frame: 12 months
Hard tissue changes will be analyzed and followed up at 3, 6 and 12 months by captured intraoral radiographs using a customized radiographic holder. The following landmarks will be measured in order to assess bone remodelling around implants * Mesial distance in mm from first bone to implant contact to implant shoulder (vertical line); * Distal distance in mm from first bone to implant contact to implant shoulder (vertical line) after implant placement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
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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.
Ana R Todorovic, DDS,PhD principal investigator
School of Dentistry, University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate loading of implants in people with Bone Loss in Jaw, run by University of Belgrade at 1 site in Serbia.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Dec 2022. 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 Serbia. 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?
Results are not available in the source record.
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?
Periimplant marginal bone loss (time frame: 12 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 29 Dec 2022.