Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.
Phase: NA
Conditions: Osseointegration Failure of Dental Implant
Sponsor: Folktandvården Skåne AB

Immediate Loading and Fully Guided Surgery: Single Implants 
NCT04061694 
Includes: Study protocol, English short version translation from Swedish. 
Date of ethical approval: 2015-11-13 
Study protocol approved 2015-11-13. 
Translation date: 2020-02-04 
 
 

Study protocol 
Prospective non-randomized clinical trial to be conducted in accordance with the Helsinki declaration 
of 1975 as revised in 2000.  
Study protocol to be sent to was approved by the Regional Ethical Review Board in Lund, Sweden 
(Dnr 2015/671). 
Patients referred to the Centre of Dental Specialist Care, Malmö to be consecutively considered for 
inclusion. 
The control group (IL) inclusion of at least 20 patients. 
Digital planned, fully guided-surgery and immediate loading group (DIL) inclusion of at least 20 
patients. 
Power calculation: 80.6%, group size 20. 
Inclusion criteria as follows: 
1. At least 18 years old. 
2. In need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla. 
3. Signed informed consent. 
Exclusion criteria as follows: 
1.  General health contraindications for oral surgery. 
2. Inadequate oral hygiene, defined as a full-mouth plaque score of above 25%. 
3. In need of bone grafting or ridge augmentation 
Immediate loading group (IL) 
The control group (IL) 25 immediately loaded (IL) dental implants. Treatment included conventional 
surgery, dental implants (Tapered Internal, BioHorizons, Birmingham, AL), immediate loading with 
temporary restorations that are fabricated manually immediately after surgery and final restorations in 
situ 2 months after surgery.  
Digital planned, fully guided-surgery and immediate loading group (DIL) 
The DIL group to be subjected to an intraoral scanning of the maxilla and antagonist arch performed 
with an IOS (Trios 3, 3Shape A/S, Copenhagen, Denmark). Cone beam computed tomography 
(CBCT) (ProMax 3D, Planmeca Oy, Helsinki, Finland) of the implant site.  

Guided surgery: Guided surgery software (Implant Studio, 3Shape, Copenhagen, Denmark). The 
implants to be positioned optimal in relation to a predesign of the prosthetic restoration and thereafter 
the appropriate implant diameter and length selected for each individualy. 
The surgical guides (E-Shell 600 Clear, Deltamed GmbH, Friedberg, Germany), made with additive 
technology, using a digital light processing (DLP) 3D printer (Vida, EnvisonTEC GmbH, Gladbeck, 
Germany). Master cylinder sleeve (BioHorizons, Birmingham, AL) incorporated into each surgical 
guide. The surgical guides to be submitted to cold sterilization according to the material suppliers’ 
guidelines. 
The temporary restorations finalised (Dental Designer, 3Shape, Copenhagen, Denmark) according to 
the intended prosthetic design and 3D printed (E-Dent 400, EnvisonTEC GmbH, Gladbeck, Germany).  
Surgery protocol DIL 
Implant should be placed into healed bone (at least 4 months after tooth loss) in sites that are free 
from clinical signs of inflammation/infection. 
Prior to surgery a single-preoperative dosage of 2 g amoxicillin. 
Installed using a guided surgery kit (BioHorizons, Birmingham, AL), mucosal tissue at the implant site 
removed with a soft tissue punch from the guided surgery kit, no mucoperiosteal flaps. 
The installation torque to be registered for each implant and resonance frequency analysis (RFA), 
measured as the implant stability quotient (ISQ).  
The temporary restorations to be immediately mounted onto the dental implants. Adjust to light centric 
contact and free from eccentric contacts, make necessary adjustments to approximal contacts points. 
Postoperatively: 0.2% chlorhexidine for 14 days. 
Definitive prosthesis procedure DIL 
Two months after surgery, intraoral scanning (Trios 3, 3Shape A/S, Copenhagen, Denmark). 
The final screw-retained single implant crown: Titanium base abutment (BioHorizons, Birmingham, AL) 
and a zirconia crown (BruxZir, Glidewell Labratories, Newport Beach, CA). 
All laboratory procedures to be performed by the same team of dental technicians and all prosthetic 
procedures to be performed by one person. 
Assessments 

DIL and IL baseline and follow-up examinations (3 and 12 months) to be conducted by the same 
person responsible for the prosthetic treatment 
Subsequent assessments of radiographs and aesthetics to be performed by an examiner not involved 
in patient treatment and blinded to patient group allocation. 
Radiographic and soft tissue 
Marginal bone loss (MBL) at baseline and 12 months. 
Digital intra-oral periapical radiographs (Schick Digital X-ray Sensor, Sirona, Salzburg, Austria) using 
the long-cone parallel technique. 
The marginal bone level measurements to be calibrated using the inter-thread distance of the dental 
implants (1.00 mm). The Image J software (National Institute of Health, Bethesda, MD) to be used for 
all measurements. 
Implant success and survival evaluated according to Albrektsson et al. 1986/1993 after 12 months. 
The gingival index (GI) by Löe and Silness 1963, baseline, 6 and 12 months. 
The papilla index by Jemt 1997, baseline, 6 and 12 months. 
Change in gingival zenith position and papilla levels measured from intraoral scanning’s acquired 
following delivery of the temporary restoration, completion of the final restoration, and at the 3 and 12 
months follow-up visits for DIL. Photographic measuring technique used for the IL group has been 
described by Gjelvold et al. 2017. 
Aesthetics 
Photographs (Nikon D7000, Nikon Corporation, Tokyo, Japan) are to be taken at definitive crown 
placement and at the 3 and 12 months follow-up appointments. 
Pink esthetic score (PES) according to Fürhauser et al. 2005.  
White esthetic score (WES) according to Belser et al. 2009. 
Perfect outcome and aesthetic failure considered according to Cosyn et al. 2012. 
Patient-centred considerations 
The validated Swedish version of the Oral Health Impact Profile (OHIP-14) according to Hägglin et al. 
2007. Recorded at the following appointments: pre-surgery visit; after two months with the temporary 
crown; on the 12 months follow-up. The additive score to be used. 
Visual analog scales (VAS) used to assess patient perceived aesthetic satisfaction, pain and 
discomfort. The aesthetic outcome scored by the patients at the same appointments as OHIP-14. Pain 

and discomfort scored after the surgery and impression appointments. The patients to mark their 
decision on a non-numerical 100 mm line ranging from "not at all satisfied, severe pain and severe 
discomfort = 0” (left) to “very satisfied, no pain and no discomfort = 100" (right). Each response then to 
be given a numerical value by measuring in millimeters the distance from the left end of the line.  
For OHIP-14 and VAS the patient are to be given the same oral and written information and then left 
alone to complete the questioners in private. 
Implant deviation from the planned implant position 
For the DIL group datasets from guides surgery software and intraoral scans after fixture installation to 
be used to measure implant deviation. The following parameters are to be calculated: deviation at 
entry point, measured at the center of the implant (in mm); deviation at apex, measured at the center 
of the implant apex (in mm); angular deviation (in degrees); deviation in vertical implant position (in 
mm, + deviation in coronal direction); and deviation in horizontal implant position (in mm).