Implant ComplicationNCT05869292
Immediate Vs. Early Loading of Immediately Placed Implants
A study testing Immediate implant loading and Early implant loading in people with Implant Complication and Implant, run by University of Belgrade at 1 site in Serbia.
Trial summary
The study aims to compare implant stabilities between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in the partial and total edentulous patients assessing marginal bone loss, oral health-related quality of life, and patient satisfaction within one, two and five… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication, Implant
- What is being tested?
- Immediate implant loading and Early implant loading
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSerbia
- Study dates
- 31 Jan 2019to 1 May 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age;
- systemically healthy;
- periodontally healthy or with stable treated periodontitis and good oral hygiene (FMPS and FMBS ≤ 15%, measured at six sites per tooth)
- Have maxillary dentition with one or multiple failing teeth
- Have sufficient bone volume to immediately place implants
- Non-smoker or light smoker
Who cannot join
- An active or chronic disease that affects bone metabolism or wound healing (ASA III type);
- Diminished mental capacities that could mitigate the ability to comply with the protocol;
- History of maxillary augmentation; oral carcinoma or inflammatory changes;
- History of head and neck radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Vs. Early Loading of Immediately Placed Bone Level Tapered Dental Implants
The study aims to compare implant stabilities between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in the partial and total edentulous patients assessing marginal bone loss, oral health-related quality of life, and patient satisfaction within one, two and five years of follow-ups.
Read the detailed description
The objectives of the study
The primary objective of this study will be to compare primary and secondary stability between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in partial and total edentulous patients. The second objective will be marginal bone level changes and soft tissue changes such as keratinised tissue width and gingival thickness which will be assessed at one, two and five years postoperatively. The gained results will assess and compared within partial and total edentulous patients.
Additionally, the study also will be analyse functional and aesthetic outcomes as well as the possibility of the complication and its prevalences including (biological, mechanical, and procedure-related complications) comparing the their incidence between partial and total edentulous patients.
Materials and methods
The study is design as a prospective, randomised, controlled clinical trial which will be conducted at School of Dental Medicine in accordance with the Declaration of Helsinki (World Medical Association, 2013) and the CONSORT Statement.
Before the treatment procedure, after clinical examination patients will be divided into two groups:
- Group A- patient requires on both sides one implant to be placed
- Group B- patient requires full-arch reconstruction
Thereafter, in the both groups, patients will be randomly divided into two subgroups in which immediate loading (test group) or early loading (six week postoperatively) will be performed.
Surgical procedure
One hour before the surgery, antibiotic prophylaxis will be administered, and the patients should rins their mouths with 0.12% chlorhexidine solution for 1 minute preoperatively. The procedures will be performed under local anesthesia using 4% articaine, 1:100.000 epinephrine. A midcrestal incision will be made, and full-thickness will be elevated. Failing tooth or teeth will be extracted using periotomes, elevators, and forceps to preserve socket walls integrity. Extracted alveolus will be immediately prepared following by the epicrestal or subcrestal implant placement. If the gap between the implant surfaces and socket walls is wider than 2 mm, bovine-derived xenograft (Geistlich Bio-Oss®, Wolhusen, Switzerland) and collagen membrane (Geistlich Bio-Gide®, Wolhusen, Switzerland) will be placed. Healing screws (Institute Straumann AG, Basel, Switzerland; NC healing abutment ∅4.8 mm conical 5 mm and RC healing abutment ∅5 mm conical 6 mm) will be placed, and primary wound closure was achieved with 5-0 single resorbable sutures (AssuCryl Lactin, Pully-Lausanne, Switzerland). The presence of apical fenestration, cortical dehiscence, an apico-marginal defect, or the need for contour augmentation will also recorded in the patient study charts. Patients will be prescribed antibiotic therapy for the next five days (Amoxicillin with clavulonic acid, 1 g, twice a day, or, in case of allergy, Clindamycin, 0.6 g, three times a day).
2.3 Prosthetic protocol
Implants in subgroup marked as the test group will be immediately loaded with temporary restorations using S-R abutments (Institute Straumann AG, Basel, Switzerland) whereas the patients from the subgroup marked as control group wouldn't receive any kind of prosthetic restauration, and will left with healing abutments (HA).
For the provisional restoration, an open tray impression technique will be used. Plaster models with scan bodies will be digitized by the laboratory scanner (3Shape E1, 3Shape, Kopenhagen, Denmark), and the virtual design of provisional restoration will be performed with 3D designing software (Exocad-Matera 2.3, Exocad, Darmstadt, Germany). Provisional restorations will be then created using polymethyl methacrylate (PMMA) (Telio®CAD, Ivoclar Vivadent, Schaan, Lichtenstein) and were drilled from PMMA blocks using the 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). Screw-retained abutments for the prosthetic bridge will be chosen according to implant angulation and surrounding soft tissue height.
At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients in both groups.
Data Collection and measurements
Implant stability, assessed as the primary study outcome, was measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) (Fig. 7b) and Penguin® (PenguinRFA, Gothenburg, Sweden).
Marginal bone loss will be assessed as the difference between the postoperative and followed up years by means of CBCT measurements.
The distance between the implant shoulder and the crestal bone will be estimated as the shortest distance, using the same HA for each patient.
The results will be statistically analysed.
- Conditions
- Implant Complication, Implant
- Being tested
- Immediate implant loading, Early implant loading
- Keywords
- immediate loading, Early loading, Marginal Bone Loss, Implant stability, Immediate implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant loadingDevice
Also called test group
Implants will be received immediately prosthetic restoration following surgical procedure.
For the provisional restoration, an open tray impression technique will be used. Plaster models with scan bodies will be digitized by the laboratory scanner (3Shape E1, 3Shape, Kopenhagen, Denmark), and the virtual design of provisional restoration will be performed with 3D designing software (Exocad-Matera 2.3, Exocad, Darmstadt, Germany). Provisional restorations will be then created using polymethyl methacrylate (PMMA) (Telio®CAD, Ivoclar Vivadent, Schaan, Lichtenstein) and were drilled from PMMA blocks using the 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). Screw-retained abutments for the prosthetic bridge will be chosen according to implant angulation and surrounding soft tissue height.
At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients.
Early implant loadingDevice
Also called control group
Implants won't receive immediately prosthetic restoration following surgical procedure and will be left only healing caps.
At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Test: Immediate implant loading | Experimental | Implants will be immediately following surgical procedure loaded with temporary restorations. Receives: Device: Immediate implant loading |
| Control: Early implant loading | Experimental | Implants will not be received prosthetic restoration, and will left with healing abutments (HA) for 6 weeks. Receives: Device: Early implant loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
Measured: Change implant stability at 12 months
Implant stability
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
Measured: Change implant stability at 2 years
Implant stability
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
Measured: Change implant stability at 5 years
Secondary outcomes (6)
Change of Marginal bone loss (MBL)
MBL will be measured in millimetres as distance between the implant shoulder and the crestal bone postoperative and one, second, and five year postoperatively by using CBCT.
Measured: Change baseline marginal bone at 12 months
Change of Marginal bone loss (MBL)
MBL will be measured in millimetres as distance between the implant shoulder and the crestal bone postoperative and one, second, and five year postoperatively by using CBCT.
Measured: Change baseline marginal bone at 2 years
Change of Marginal bone loss (MBL)
MBL will be measured in millimetres as distance between the implant shoulder and the crestal bone postoperative and one, second, and five year postoperatively by using CBCT.
Measured: Change baseline marginal bone at 5 years
Change of keratinised tissue width (KTW)
KTW will be measured in millimetres at the middle of the inserted implant as the distance between the free MM to a mucogingival junction (MGJ)
Measured: Change baseline marginal bone at 12 months
Change of keratinised tissue width (KTW)
KTW will be measured in millimetres at the middle of the inserted implant as the distance between the free MM to a mucogingival junction (MGJ)
Measured: Change baseline marginal bone at 2 years
Change of keratinised tissue width (KTW)
KTW will be measured in millimetres at the middle of the inserted implant as the distance between the free MM to a mucogingival junction (MGJ)
Measured: Change baseline marginal bone at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start31 Jan 2019
- Primary completion15 May 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Implant ComplicationStudies 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
- The study is design as a prospective, randomised, controlled clinical trial. Depending on number of extracted teeth patients will be randomly allocated into Test group in which immediate loading following surgical procedure will be conducted Control group in which early loading (six weeks postoperatively) will be performed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksa Markovic, University of Belgrade
- Investigators
- Aleksa Markovic, Professor, Study director, School of Dental Medicine, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869292
- Sponsor's protocol ID
- 36/16
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The one and two years outcome will be statistically analysed and published in the journal which will be shared and available to public.
Publications
Chambrone L, Shibli JA, Mercurio CE, Cardoso B, Preshaw PM. Efficacy of standard (SLA) and modified sandblasted and acid-etched (SLActive) dental implants in promoting immediate and/or early occlusal loading protocols: a systematic review of prospective studies. Clin Oral Implants Res. 2015 Apr;26(4):359-370. doi: 10.1111/clr.12347. Epub 2014 Feb 21.
PubMed 24814519Chung S, McCullagh A, Irinakis T. Immediate loading in the maxillary arch: evidence-based guidelines to improve success rates: a review. J Oral Implantol. 2011 Oct;37(5):610-21. doi: 10.1563/AAID-D-JOI-10-00058.1.
PubMed 22004059Del Fabbro M, Testori T, Kekovic V, Goker F, Tumedei M, Wang HL. A Systematic Review of Survival Rates of Osseointegrated Implants in Fully and Partially Edentulous Patients Following Immediate Loading. J Clin Med. 2019 Dec 4;8(12):2142. doi: 10.3390/jcm8122142.
PubMed 31817177Garcia-Sanchez R, Dopico J, Kalemaj Z, Buti J, Pardo Zamora G, Mardas N. Comparison of clinical outcomes of immediate versus delayed placement of dental implants: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Mar;33(3):231-277. doi: 10.1111/clr.13892. Epub 2022 Jan 28.
PubMed 35044012Ibrahim A, Chrcanovic BR. Dental Implants Inserted in Fresh Extraction Sockets versus Healed Sites: A Systematic Review and Meta-Analysis. Materials (Basel). 2021 Dec 20;14(24):7903. doi: 10.3390/ma14247903.
PubMed 34947493Markovic A, Misic T, Janjic B, Scepanovic M, Trifkovic B, Ilic B, Todorovic AM, Markovic J, Dard MM. Immediate Vs Early Loading of Bone Level Tapered Dental Implants With Hydrophilic Surface in Rehabilitation of Fully Edentulous Maxilla: Clinical and Patient Centered Outcomes. J Oral Implantol. 2022 Oct 1;48(5):358-369. doi: 10.1563/aaid-joi-D-21-00045.
PubMed 34937085
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Vs. Early Loading of Immediately Placed Bone Level Tapered Dental Implants
- ClinicalTrials.gov ID
- NCT05869292
- Acronym / sponsor ID
- 36/16
- Conditions
- Implant Complication, Implant
- Keywords
- immediate loading, Early loading, Marginal Bone Loss, Implant stability, Immediate implant placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 22 May 2023 (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 study aims to compare implant stabilities between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in the partial and total edentulous patients assessing marginal bone loss, oral health-related quality of life, and patient satisfaction within one, two and five years of follow-ups.
Detailed description
The objectives of the study
The primary objective of this study will be to compare primary and secondary stability between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in partial and total edentulous patients. The second objective will be marginal bone level changes and soft tissue changes such as keratinised tissue width and gingival thickness which will be assessed at one, two and five years postoperatively. The gained results will assess and compared within partial and total edentulous patients.
Additionally, the study also will be analyse functional and aesthetic outcomes as well as the possibility of the complication and its prevalences including (biological, mechanical, and procedure-related complications) comparing the their incidence between partial and total edentulous patients.
Materials and methods
The study is design as a prospective, randomised, controlled clinical trial which will be conducted at School of Dental Medicine in accordance with the Declaration of Helsinki (World Medical Association, 2013) and the CONSORT Statement.
Before the treatment procedure, after clinical examination patients will be divided into two groups:
- Group A- patient requires on both sides one implant to be placed
- Group B- patient requires full-arch reconstruction
Thereafter, in the both groups, patients will be randomly divided into two subgroups in which immediate loading (test group) or early loading (six week postoperatively) will be performed.
Surgical procedure
One hour before the surgery, antibiotic prophylaxis will be administered, and the patients should rins their mouths with 0.12% chlorhexidine solution for 1 minute preoperatively. The procedures will be performed under local anesthesia using 4% articaine, 1:100.000 epinephrine. A midcrestal incision will be made, and full-thickness will be elevated. Failing tooth or teeth will be extracted using periotomes, elevators, and forceps to preserve socket walls integrity. Extracted alveolus will be immediately prepared following by the epicrestal or subcrestal implant placement. If the gap between the implant surfaces and socket walls is wider than 2 mm, bovine-derived xenograft (Geistlich Bio-Oss®, Wolhusen, Switzerland) and collagen membrane (Geistlich Bio-Gide®, Wolhusen, Switzerland) will be placed. Healing screws (Institute Straumann AG, Basel, Switzerland; NC healing abutment ∅4.8 mm conical 5 mm and RC healing abutment ∅5 mm conical 6 mm) will be placed, and primary wound closure was achieved with 5-0 single resorbable sutures (AssuCryl Lactin, Pully-Lausanne, Switzerland). The presence of apical fenestration, cortical dehiscence, an apico-marginal defect, or the need for contour augmentation will also recorded in the patient study charts. Patients will be prescribed antibiotic therapy for the next five days (Amoxicillin with clavulonic acid, 1 g, twice a day, or, in case of allergy, Clindamycin, 0.6 g, three times a day).
2.3 Prosthetic protocol
Implants in subgroup marked as the test group will be immediately loaded with temporary restorations using S-R abutments (Institute Straumann AG, Basel, Switzerland) whereas the patients from the subgroup marked as control group wouldn't receive any kind of prosthetic restauration, and will left with healing abutments (HA).
For the provisional restoration, an open tray impression technique will be used. Plaster models with scan bodies will be digitized by the laboratory scanner (3Shape E1, 3Shape, Kopenhagen, Denmark), and the virtual design of provisional restoration will be performed with 3D designing software (Exocad-Matera 2.3, Exocad, Darmstadt, Germany). Provisional restorations will be then created using polymethyl methacrylate (PMMA) (Telio®CAD, Ivoclar Vivadent, Schaan, Lichtenstein) and were drilled from PMMA blocks using the 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). Screw-retained abutments for the prosthetic bridge will be chosen according to implant angulation and surrounding soft tissue height.
At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients in both groups.
Data Collection and measurements
Implant stability, assessed as the primary study outcome, was measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) (Fig. 7b) and Penguin® (PenguinRFA, Gothenburg, Sweden).
Marginal bone loss will be assessed as the difference between the postoperative and followed up years by means of CBCT measurements.
The distance between the implant shoulder and the crestal bone will be estimated as the shortest distance, using the same HA for each patient.
The results will be statistically analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is design as a prospective, randomised, controlled clinical trial. Depending on number of extracted teeth patients will be randomly allocated into Test group in which immediate loading following surgical procedure will be conducted Control group in which early loading (six weeks postoperatively) will be performed.
| Arm | Type | Receives |
|---|---|---|
| Test: Immediate implant loading | Experimental | Device: Immediate implant loadingImplants will be immediately following surgical procedure loaded with temporary restorations. |
| Control: Early implant loading | Experimental | Device: Early implant loadingImplants will not be received prosthetic restoration, and will left with healing abutments (HA) for 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥ 18 years of age;
- systemically healthy;
- periodontally healthy or with stable treated periodontitis and good oral hygiene (FMPS and FMBS ≤ 15%, measured at six sites per tooth)
- Have maxillary dentition with one or multiple failing teeth
- Have sufficient bone volume to immediately place implants
Key exclusion criteria (4 listed)
- An active or chronic disease that affects bone metabolism or wound healing (ASA III type);
- Diminished mental capacities that could mitigate the ability to comply with the protocol;
- History of maxillary augmentation; oral carcinoma or inflammatory changes;
- History of head and neck radiotherapy.
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 implant loadingAlso: test groupImplants will be received immediately prosthetic restoration following surgical procedure. For the provisional restoration, an open tray impression technique will be used. Plaster models with scan bodies will be digitized by the laboratory scanner (3Shape E1, 3Shape, Kopenhagen, Denmark), and the virtual design of provisional restoration will be performed with 3D designing software (Exocad-Matera 2.3, Exocad, Darmstadt, Germany). Provisional restorations will be then created using polymethyl methacrylate (PMMA) (Telio®CAD, Ivoclar Vivadent, Schaan, Lichtenstein) and were drilled from PMMA blocks using the 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). Screw-retained abutments for the prosthetic bridge will be chosen according to implant angulation and surrounding soft tissue height. At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients. | Device | Test: Immediate implant loading |
| Early implant loadingAlso: control groupImplants won't receive immediately prosthetic restoration following surgical procedure and will be left only healing caps. At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients. | Device | Control: Early implant loading |
Primary outcome
Implant stability
Time frame: Change implant stability at 12 months
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
Implant stability
Time frame: Change implant stability at 2 years
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
Implant stability
Time frame: Change implant stability at 5 years
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
6 secondary outcomes
Change of Marginal bone loss (MBL)
Time frame: Change baseline marginal bone at 12 months
Change of Marginal bone loss (MBL)
Time frame: Change baseline marginal bone at 2 years
Change of Marginal bone loss (MBL)
Time frame: Change baseline marginal bone at 5 years
Change of keratinised tissue width (KTW)
Time frame: Change baseline marginal bone at 12 months
Change of keratinised tissue width (KTW)
Time frame: Change baseline marginal bone at 2 years
Change of keratinised tissue width (KTW)
Time frame: Change baseline marginal bone at 5 years
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 22 May 2023.
- Background: PubMed 24814519Chambrone L, Shibli JA, Mercurio CE, Cardoso B, Preshaw PM. Efficacy of standard (SLA) and modified sandblasted and acid-etched (SLActive) dental implants in promoting immediate and/or early occlusal loading protocols: a systematic review of prospective studies. Clin Oral Implants Res. 2015 Apr;26(4):359-370. doi: 10.1111/clr.12347. Epub 2014 Feb 21.
- Background: PubMed 22004059Chung S, McCullagh A, Irinakis T. Immediate loading in the maxillary arch: evidence-based guidelines to improve success rates: a review. J Oral Implantol. 2011 Oct;37(5):610-21. doi: 10.1563/AAID-D-JOI-10-00058.1.
- Background: PubMed 31817177Del Fabbro M, Testori T, Kekovic V, Goker F, Tumedei M, Wang HL. A Systematic Review of Survival Rates of Osseointegrated Implants in Fully and Partially Edentulous Patients Following Immediate Loading. J Clin Med. 2019 Dec 4;8(12):2142. doi: 10.3390/jcm8122142.
- Background: PubMed 35044012Garcia-Sanchez R, Dopico J, Kalemaj Z, Buti J, Pardo Zamora G, Mardas N. Comparison of clinical outcomes of immediate versus delayed placement of dental implants: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Mar;33(3):231-277. doi: 10.1111/clr.13892. Epub 2022 Jan 28.
- Background: PubMed 34947493Ibrahim A, Chrcanovic BR. Dental Implants Inserted in Fresh Extraction Sockets versus Healed Sites: A Systematic Review and Meta-Analysis. Materials (Basel). 2021 Dec 20;14(24):7903. doi: 10.3390/ma14247903.
- Background: PubMed 34937085Markovic A, Misic T, Janjic B, Scepanovic M, Trifkovic B, Ilic B, Todorovic AM, Markovic J, Dard MM. Immediate Vs Early Loading of Bone Level Tapered Dental Implants With Hydrophilic Surface in Rehabilitation of Fully Edentulous Maxilla: Clinical and Patient Centered Outcomes. J Oral Implantol. 2022 Oct 1;48(5):358-369. doi: 10.1563/aaid-joi-D-21-00045.
- Individual participant dataSharing planned: Yes. The one and two years outcome will be statistically analysed and published in the journal which will be shared and available to public.
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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.
Aleksa Markovic, Professor study director
School of Dental Medicine, 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 implant loading and Early implant loading in people with Implant Complication and Implant, 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 6 inclusion and 4 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 22 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 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?
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?
Implant stability (time frame: Change implant stability at 12 months). The study lists 3 primary outcomes in all. 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 NCT05869292, which also lists 6 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 22 May 2023.