Immediate vs Conventional Loading for Early Implant Placement
ConditionDental Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Belgrade
About this trial
The goal of this study is to assess clinical, radiological and patient centred outcomes of immediate and conventional implant loading protocols, and to compare clinical outcomes of these two different loading protocols (immediate and conventional) in combination with early implant placement of single implants in the esthetic zone of maxilla.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Single failing tooth in the esthetic zone of maxilla (second premolar to second premolar)
Patients older than 18 years
Healthy patients ASA I and II
Non-smokers/Light smokers (<10 cigarettes per day)
Disqualifiers
Implants adjacent to the failing teeth
Active periodontal infection
Severe bruxism
Systemic or local conditions that contraindicates dental implant surgery - Heavy smokers (>10 cigarettes per day)
Trial design
Design model
Parallel
Treatments tested in this trial
Early implant placement with immediate provisional restoration
DeviceImplants 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
DeviceImplants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Test group (Early implant placement + immediate provisionalization)Experimental treatment 1 intervention
Group B: Control group (Early implant placement + delayed loading)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Marginal bone level changes
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.
Time frame
1 year2
Pink esthetic score
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. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue color and texture) are assessed with a score 0, 1 or 2. Highest possible score is 14.
Time frame
1 yearSecondary outcomes
1
Implant survival
Implant survival is assessed at provisional restoration delivery, final restoration delivery and at 1 year follow up
Time frame
1 year2
Facial bone wall width
Facial bone wall width is measured in mm at CBCT scans obtained immediately after implant placement and 1 year after final restoration delivery
Time frame
1 year3
Alveolar ridge volume
Alveolar ridge volume changes will be measured in mm in the image analysis software , by superimposing digital models (STL files) obtained prior to tooth extraction, prior to implant placement, at final restoration delivery, and 1year after final restoration delivery.
Time frame
1 year4
Patient satisfaction
Patient satisfaction regarding function and aesthetics (mucosa, crown and overall) would be assessed using visual analogue scale (VAS). It is recorded in 4 time points: before tooth extraction, before implant placement, 1 month after definitive crown delivery and after 1 year of function.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Belgrade
Lead sponsor
ITI International Team for Implantology, Switzerland
Collaborator
Source ClinicalTrials.gov