Immediate vs Conventional Loading for Early Implant Placement
NCT ID: NCT06526351
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-29
2027-03-31
Brief Summary
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Detailed Description
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During the first appointment, medical history and clinical and radiological evaluations (OPG) will be recorded to verify the eligibility of each subject. If the sufficient bone is present apical to the failing tooth, intraoral scan of the upper jaw will be obtained prior to tooth extraction. Six to eight weeks following tooth extraction CBCT scan will be obtained together with digital impression. The implant positions will be planned according to the bone anatomy and future prosthetic reconstruction. Two groups of treatment protocols will be randomized as following:
Group 1: Early implant placement + immediate provisionalisation; Group 2: Early implant placement + conventional loading.
Implant surgery will be performed by two experienced surgeons. Full thickness triangular flap will be elevated, and fully guided implant placement will be completed. Under-preparation of implant bed in the soft bone will be utilized to obtain adequate primary stability. During the surgery, primary implant stability will be monitored by the means of insertion torque (IT) and resonance frequency analysis (RFA) Contour augmentation will be done for all patients from both groups by means of locally collected autogenous bone chips and deproteinized bovine bone particles, covered by a collagen membrane. Depending on the group, healing cap or healing abutment will be selected, and primary wound closure will be achieved.
Prosthetic rehabilitation:
All impressions will be taken digitally using intraoral scanner and appropriate implant scanbody.
Titanium temporary abutments will be used for provisional restorations, and titanium base abutments for the definitive restoration. Provisional restorations will be made of polymethyl methacrylate (PMMA) (Telio®CAD, Ivoclar Vivadent, Schaan, Lichtenstein) in a digital way. Digital scanning for final restorations and virtual design will be repeated in the same manner. Full ceramic screw-retained crown will be fabricated in a digital way and delivered to the patients.
Group 1:
Immediate screw-retained provisional restoration made of poly methyl methacrylate (PMMA) will be delivered within the first 7 days after surgery. Three months later, final screw-retained full ceramic crown will be fabricated and delivered.
Group 2:
Three months after the surgery, implant will be exposed and provisional screw-retained PMMA restoration delivered. Three months later final screw-retained ceramic crown will be fabricated.
Implant stability will be monitored through RFA. ISQ will be measured in both groups:
* At the day of the implant placement
* At the day of the provisional restoration placement
* At the day of the definitive restoration placement
CBCT scan with a small field of view will be taken prior to implant placement, immediately after implant placement, and 1 year after implant placement. Post-op CBCT scans will be used for measurement of the facial bone wall thickness. Marginal bone level will be monitored using periapical radiographs taken with paralleling technique, using custom silicone holder fabricated for each patient. X-rays will be taken on the day of the provisional restoration placement, final restoration placement, and one year after final restoration.
Esthetic outcome for the peri-implant mucosa will be assessed from the photographs taken at the definitive restoration delivery and 1 year follow-up visit, using pink esthetic score (PES). Patient satisfaction regarding function and aesthetics (mucosa, crown and overall) would be assessed using visual analogue scale (VAS). Quality of life would be examined by OHIP-14 questionnaire. These Patient Reported Outcome Measures (VAS and OHIP-14) would be recorded at 3 time points: before implant placement (baseline), 1 month after definitive crown delivery and after 1 year of function.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Test group (Early implant placement + immediate provisionalization)
Patients in test group receive an implant 6 to 8 weeks following tooth extraction with immediate provisional restoration
Early implant placement with immediate provisional restoration
Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Immediate provisional restoration will be delivered.
Control group (Early implant placement + delayed loading)
Patients in control group receive an implant 6 to 8 weeks following tooth extraction with submerged healing and conventional loading
Early implant placement with delayed loading
Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Delayed loading protocol followed.
Interventions
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Early implant placement with immediate provisional restoration
Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Immediate provisional restoration will be delivered.
Early implant placement with delayed loading
Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Delayed loading protocol followed.
Eligibility Criteria
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Inclusion Criteria
* Patients older than 18 years
* Healthy patients ASA I and II
* Non-smokers/Light smokers (\<10 cigarettes per day)
* Adequate bone volume apical and palatal to the failing tooth to allow for sufficient primary - implant stability of regular diameter implant
Exclusion Criteria
* Active periodontal infection
* Severe bruxism
* Systemic or local conditions that contraindicates dental implant surgery - Heavy smokers (\>10 cigarettes per day)
18 Years
ALL
Yes
Sponsors
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ITI International Team for Implantology, Switzerland
OTHER
University of Belgrade
OTHER
Responsible Party
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Aleksa Markovic
Professor
Principal Investigators
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Aleksa Markovic, Professor
Role: PRINCIPAL_INVESTIGATOR
Chair of Implant Center, School of Dental Medicine
Locations
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Implant Center, School of Dental Medicine, Univeristy of Blegrade
Belgrade, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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36/2
Identifier Type: -
Identifier Source: org_study_id
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