Immediate vs Conventional Loading for Early Implant Placement
NCT Number: NCT06526351
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant
Interventions: DEVICE: Early implant placement with immediate provisional restoration|DEVICE: Early implant placement with delayed loading
Sponsor: University of Belgrade
Collaborators: ITI International Team for Implantology, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-29
Completion Date: 2027-03
Locations: Implant Center, School of Dental Medicine, Univeristy of Blegrade, Belgrade, 11000, Serbia

Summary:
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.

Primary Outcome Measures: 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., 1 year|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., 1 year
Secondary Outcome Measures: Implant survival, Implant survival is assessed at provisional restoration delivery, final restoration delivery and at 1 year follow up, 1 year|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, 1 year|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., 1 year|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., 1 year|Impact of oral health on patient's quality of life, Oral Health Impact Profile (OHIP-14) questionnare will be used. Patients will fill a questionnare of 14 questions with responses made on a 5-point scale, coded 0 (never), 1 (hardly ever), 2 (occasionally), 3 (fairly often), and 4 (very often). Scores can range from 0 to 56, with higher OHIP-14 scores indicating worse and lower scores indicating better oral health related quality of life. 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., 1 year