Comparing cooling and non cooling of burs during placement of dental implants.

During osteotomy preparation, the exposure of bone to a temperature of 47 °C
for one minute can cause bone resorption and necrosis (Eriksson & Albrektsson,
1983; Eriksson & Albrektsson, 1984). But when using computer aided implant
surgery (CAIS), cooling never find its way to the drills, since the surgical
guides are often close structures supported either on teeth, mucosa or bone.
Recently, the thermal osteonecrosis and drilling parameters are revisited and
it has been demonstrated that osteotomy preparation can be performed in all
types of bone without external or internal irrigation (Flanagan, 2010). An
advantage of avoiding this aqueous irrigation is that bone chips will remain
attached to the drill flukes during the implant osteotomy preparation. Tabassum
et al. (IJOMI accepted 20191) demonstrated that the osteogenic efficacy of
autogenous bone particles collected using low-speed drilling without cooling
was superior compared with standard drill samples.

It is possible to avoid aqueous irrigation without detrimental effects on bone
by adopting a low-speed drilling protocol which does not produce heat exceeding
47°C due to less frictional heat generation (Anitua, Carda, & Andia, 2007;
Anitua, Prado, & Orive, 2009; Giro et al., 2011;). Augistin et al. demonstrated
that the temperature range without external irrigation at 188 rpm was 31.4 -
36.9°C and at 462 rpm was 35.2 - 43.0°C (2008). Therefore, nowadays low-speed
drilling is commonly employed during osteotomy preparation without saline
irrigation.

Primary objective:
The primary goal of this research is to compare peri-implant hard tissue around
implants placed using a modified drilling protocol, i.e. a reduced drilling
speed without cooling and around implants inserted using a default drilling
protocol.

For this purpose, the marginal bone level around implants of both groups will
be compared using CBCT radiography.

Secondary objectives:
Evaluation of the Periodontal parameters (PD, BoP)
Evaluation of the precision of guided implant insertion in practice by
superimposing volumetric 3D models.
3D soft tissue contour comparison
Patient reported outcomes measurements
Evaluation of the used drills in each drilling method

The study design is a prospective randomized controlled clinical trial (RCT).
Patients with one of the following indications and who fulfil the
inclusive/exclusive criteria (paragraph 3.1.1.), will be enrolled in the study:
One single implant in the (pre) molar maxilla or mandible [#4-#7]
two non-adjacent (single) implants in the (pre)molar maxilla and/or mandible
[#4-#7]
In all indication the proximal part of the (proximal) implant must be adjacent
to a natural tooth.
Randomization will allocate patients into two groups: the test group with a
modified drill protocol (TG) and (2) the control group with a default drill
protocol (CG).

Implant success/survival will be analyzed and followed up until 1 year after
implant loading.

Control Group:
Default drillings protocol according to the manufacture recommendation.

Test Group:
Modified drillings protocol:
Drillings speed limited to 200 RPM
No drill cooling is applied

For both study groups: Included patients will be operated by 3 surgeons
(researchers 1, 3, 4; researcher 1 present in all the surgeries).
The following medication will be prescribed to the patients: Chlorhexidine
mouth rinse (Perio Aid, Dentaid, Benelux), starting 2 days prior to surgery and
extended for 2 weeks after surgery; antibiotic prophylaxis, Amoxicillin 2g 1
hour prior to surgery (in case of hypersensitivity to Amoxicillin, 600mg of
Clindamycin 1 hour prior to surgery) and analgesic, Ibuprofen 600mg 3/day for 3
days, or in case of hypersensitivity to Ibuprofen 1000 mg of Paracetamol
4-6/day for 3 days.
After administering local anesthetics (Septanest SP, 40 mg/nml Articaine
hydrochloride + 10 µg/ml Adrenaline tartrate), a minimal mid-crestal flap will
be elevated with the purpose to conserve keratinized gingiva on the buccal side
of the implant. The surgical template will be placed. For the control group,
the drilling protocol will be used according to the manufacturer*s
recommendations (CAMLOG, Germany) after which the planned implant (table 3)
will be inserted guided, 2 mm apical to the planned cervical margin, according
to prosthetic plan. For the test group, the drilling sequence will be followed
according the manufacture*s recommendation except the drilling speed which is
limited to 200 RPM and where no drill cooling is applied, after which the
planned implant (table 3) will be inserted guided, 2 mm apical to the planned
cervical margin, according to prosthetic plan.
Implant placement has to be implemented with minimal 20N insertion torque
force. To control this parameter, the torque in the Implant hand-piece motor
will be established at 20N, and it has to get stuck before completion of
implant insertion.

Before suturing, a healing abutment will be placed. Suturing will be completed
with mesial and distal double sling sutures using Ethicon, coated, Vicryl
Rapide 3.0, Polyglactin 910. To ensure maximum approximation of the flaps
without tension, semi-lunar thinning of the lingual flap can be done, according
to case specific demands.
Light pressure with a gauze damped in chlorhexidine will be applied over the
surgical site for 1 min. Oral and written instructions will be given to the
patient concerning post- surgical care (table 5).
For each a group, a different surgical set will be used. At the end of the
surgical phase i.e. when all patients have received their planned implants, the
drills will be analysed (REM).

Completing of a questionnaire (during follow up, 4 times in total)