Immediate Vs. Early Loading of Immediately Placed Implants
Condition: Implant Complication; Implant
Study type: Interventional

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 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:

        1. Group A- patient requires on both sides one implant to be placed

        2. 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.
    

Intervention name(s): Immediate implant loading; Early implant loading
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Other intervention name(s): test group; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary purpose: Treatment
Keywords: immediate loading; Early loading; Marginal Bone Loss; Implant stability; Immediate implant placement