Immediate Vs. Conventional Loading for Early Implant Placement in the Esthetic Zone of Maxilla: Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Belgrade
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Marginal bone level changes
Study Overview
Brief 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.
Detailed Description
Patients with a single failing tooth in the esthetic zone of maxilla (second premolar to second premolar), and in need for implant replacement will be recruited.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
- •Adequate bone volume apical and palatal to the failing tooth to allow for sufficient primary - implant stability of regular diameter implant
Exclusion Criteria
- •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)
Arms & Interventions
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
Intervention: Early implant placement with immediate provisional restoration (Device)
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
Intervention: Early implant placement with delayed loading (Device)
Outcomes
Primary Outcomes
Marginal bone level changes
Time Frame: 1 year
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.
Pink esthetic score
Time Frame: 1 year
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.
Secondary Outcomes
- Facial bone wall width(1 year)
- Implant survival(1 year)
- Alveolar ridge volume(1 year)
- Patient satisfaction(1 year)
- Impact of oral health on patient's quality of life(1 year)
Investigators
Aleksa Markovic
Professor
University of Belgrade