Osteotomy Protocol for Implant Insertion of One Day Biotech: One Drill, One Implant (2024)

1. Introduction

Since the development of the concept of osseointegration [1] , bone osteotomy for implant insertion has aimed at controlling the main factors leading to osseointegration failure. The improvements include avoiding infection, calibrating the osteotomy with respect to the implant diameter, and keeping the protein below denaturation temperature during the surgical act [2] [3] .

With respect to the first point, avoiding infection, Prof. I Branemark [4] remarked that implant surgery is an orthopedic surgery and must follow the same principles: asepsis of the room (disinfection of the surfaces of the environment), of the surgeon (hands, clothing, sterile field), of the material (micromotor, contra-angle handpiece, surgical kit, implant kit) and of the patient (mouth, anesthesia).

The second point, or “osteotomy calibration,” has undergone an important change from its beginnings to the present day. Nowadays, surgeons have adopted the “self-tapping” technique: implants do not need tapping, and the threads do not need to penetrate the bone. These features result in greater primary stability and shorter working time (Figure 1).

The third point, “keeping the protein below the protein denaturation temperature,” or equivalently, “maintaining bone temperature at physiological levels,” has undergone the greatest evolution [5] [6] [7] . This development can be divided into maintaining suitable temperatures in soft and hard tissue, respectively.

With respect to soft tissue, the surgical procedure must be atraumatic, aseptic, and ensure perfect coagulation and hermetic suture.

There is greater controversy with respect to conditions of the hard tissue, even though all techniques aim to follow the second poin. Here is the reasoning: if hard tissue temperature exceeds 47˚C for 30 seconds or 40˚C for 7 minutes [8] , or 55˚ bone necrosis will occur [9] [10] . Denaturation of alkaline phosphatase takes place at 56˚C.

There are three basic milling techniques; 1) Sequential milling, derived from the Brånemark protocol (1969); 2) Low speed milling, known as biological milling; and 3) Milling with a single bur.

The initial phase is common to all three procedures:

pilot drill, between 0.8 and 1.2 mm in diameter, at 800 to 1500 rpm in speed.

In the second phase, widening, each technique differs in its approach to avoid overheating of the bone [11] .

In the protocols derived from Brånemark [12] [13] , sequential drilling always relies on the use of refrigerated saline solution, at speeds between 800 and 1300 rpm [14] [15] with external or internal irrigation drills [16] .

In the biological drilling procedure, the increase in temperature is controlled by decreasing drilling speed (50 rpm) and increasing the attack force (50 - 80 Nw) without the use of physiological saline solution. In particular, Mathews [17] remarked that without irrigation, the temperature increases. Sarendranath [18] made the same remark several years later.

The single bur drilling technique, a variant of the Brånemark technique, avoids all intermediate steps thanks to the bur’s macromorphology. This approach does not increase temperature, thus reducing the risk of infection and bone necrosis, and improves the macromorphology of the implant osteotomy [19] [20] .

The quality of the bone, including cortical thickness and cancellous density, will influence all three techniques [21] [22] [23] [24] .

The most classic classifications of bone are: Lekholm U_Zarb GA (Figure 2) and Misch C (Figure 3).

With this background information in mind, the main objective of this article is to determine the heat generated during osteotomy by the three bone milling techniques. Secondary objectives include describing the surgical protocol of One day Biotech (One Drill-One implant), assessing the concordance of implant bed osteotomy morphology with implant diameter, measuring the volume of autologous bone harvested during osteotomy for an implant, and determining the percentage of osteo-integrated implants at eight weeks according to the technique used.

2. Materials and Methods

The study was conducted by measuring outcomes in 90 cases, divided into three groups of 30 cases each.

The materials used in the experimental phase were Plexiglas sheets and pine wood. The materials used in the clinical phase were: TSK surgical kit by Phibo: One Drill kit by One Day Biotech and Bis by Biotech Dental. The implant used was always 4.5 mm in diameter and 10 mm in length.

Torque was measured with a torque wrench, AFR with the Osstel ISQ, time with a stopwatch and osteointegration at eight weeks was determined as Yes or No.

The data obtained were processed using the SPSS 23 program, with a confidence level of 95%, considered statistically significant when P < 0.05. If the p-value is less than 0.05, then we reject the null hypothesis. The Saphiro-Wilk test was used as a normality test.

The criteria for selecting test subjects were as follows:

Inclusion Criteria:

· Adult patients over 18 years of age;

· Patients requiring implant treatment and possessing sufficient bone, thus eliminating the need for GTR or complementary surgical techniques;

· Patients agreeing to sign the informed consent form and committing to attending check-up appointments.

Exclusion Criteria:

· Patients with endocrine-metabolic diseases;

· Patients with acute or chronic infectious diseases;

· Patients with a history of taking bisphosphonates;

· Patients with a history of smoking;

· Patients with post-extraction sockets;

· Patients with immediate implants.

2.1. Experimental Phase

All procedures indicate use of milling drill for implants of 4.5 mm in diameter and 10 mm in depth.

2.1.1. Temperature Reached

Performed using passive thermography according to UNL-EN 16/14-I: 2017, measuring the apparent temperature, with no use of compensation parameters of the thermal detector (Table 1).

The P-value of the ANOVA test is 2.02E−66, which is less than 0.05. Therefore, we can affirm that there is a relationship between different types of drilling with irrigation and heat generated during osteotomy, while the One Drill temperature is lower than the sequential milling by an average of 9.13 degrees (Table 1(a), Table 1(b)).

The P-value of the ANOVA test is 1.80E−122, which is less than 0.05, therefore we can affirm that there is a relationship between the different types of drilling without irrigation and heat generated during osteotomy, with the FB obtaining the lowest increase in temperature with respect to the One Drill milling cutters, by an average of 8.69 degrees (Table 1(c), Figure 4).

2.1.2. Osteotomy Morphology

Performed with the use of pine wood sticks.

We define “Hardness” as the resistance to tool penetration, using the Brinell scale. Pine wood with a Brinell hardness of 1.6 Class A and a thickness of 12 mm was chosen.

Osteotomy morphology was measured indirectly by comparing it to the reamer diameter (Table 2).

The P-value of the ANOVA test is 4.85E−06, which is less than 0.05. Therefore, we can affirm that there is a relationship between the different types of drilling and the morphology of the cervical osteotomy, with the One Drill producing the best result (Table 2(a), Table 2(b)).

The P-value of the ANOVA test is 0.048, which is less than 0.05. Therefore, we can affirm that there is a relationship between the different types of apical osteotomy morphology and the type of drill used, with the One Drill drills producing the best data (Table 2(c)).

2.2. Clinical Phase

2.2.1. Surgical Protocol of the One Day Biotech One Drill Kit

The surgical protocol varies depending on the type of bone.

The standard protocol is used on Type II bone (Figure 5). Begin by marking the cortex using the guide drill, which serves as a pilot drill, at 1200 rpm. Proceed directly with the final One Drill, ensuring its diameter matches that of the selected implant. The length is determined by the Stopper. The numbers 3.8, 4.0, 4.5, 5.0 represent the implant diameters. The drill is consistently under-dimensioned by 0.4 mm.

In Type III bone, the guide drill is not necessary.

In Type IV bone, we directly use the One Drill with a diameter smaller than that of the implant.

In Type I bone, the Guide Drill is used, followed by the Lindeman 2 mm drill, the One Drill of the corresponding diameter, and finally the Counter Sink drill. In the case of very dense bone, the One Drill is followed by the Twist Drill (Figure 6).

Once the osteotomy is completed, we unscrew the active part of the handle and remove the autologous bone using the stem of the Bone Pusher (Figure 7).

Summary of milling frequency according to bone type

2.2.2. Volume of Autologous Bone Harvested with the Drilling of the Osteotomy for an Implant of 4.5 mm in Diameter and 10 mm in Length, Measured in Cubic Centimeters (Table 3)

The P-value of the ANOVA test is 6.83E−26, which is less than 0.05. Therefore, we can affirm that there is a relationship between the different types of milling and the bone collected. The FB milling cutter is the one that collects most bones, followed by the One Drill milling cutter (Table 3(a), Table 3(b)).

2.2.3. Percentage of Osseointegrated Implants Eight Weeks after Insertion

Success or failure of osseointegration was determined at 12 weeks, according to the criteria of Albrektsson [25] (Table 4).

When comparing both the FS and F One Drill techniques, as well as the FBio and F One Drill techniques, the P-value of the null hypothesis exceeds 0.05. Therefore, we accept the hypothesis that osseointegration is independent of the drilling technique (Table 4(a)).

2.2.4. Duration of Osteotomy and Primary Stability of the Implant

We measured the following indirectly: Osteotomy duration and primary implant stability, and insertion torque and frequency analysis (RFA).

The time was measured from the beginning of the osteotomy to its completion with a stopwatch. Insertion torque was measured with the torque wrench (Ti). Resonance frequency analysis (RFA) was measured with the Osstel ISQ (Table 5).

The P-value of the ANOVA test is 0.81, which is greater than 0.05, so we can affirm that there is no relationship between the torque achieved and the milling system used (Table 5(a), Table 5(b)).

The P-value of the ANOVA test is 0.72, which is greater than 0.05. Therefore, we can affirm that there is no relationship between the ISQ of the different types of milling (Table 5(c)).

The P-value of the ANOVA test is 2.22E−59, which is less than 0.05. Therefore, we can affirm that there is a relationship between the different types of milling and the milling time. Milling with One Drill is the fastest with an average of 6.4 seconds (Table 5(d)).

3. Discussion

In our study, heat generated is directly related to drilling technique, material used, bone quality and osteotomy depths, in a manner similar to Eriksson [26] .

Heat is generated in three zones (Figure 8): the first or shear zone (bone/chip); the secondary (tool/chip); and the tertiary (tool/bone), which directly relates to the wear of the bur (frictional heat). In total, 98% of the consumed energy is transformed into heat [27] .

Most systems offer similar speeds: pilot milling cutter at 800 rpm; helical milling cutters at 1200 rpm; and tap milling cutter at 50 rpm [28] [29] [30] . The only method that differs is low-speed milling or biological milling, at the cost of increasing cutting force [31] .

The formula below indicates that heat equals shear force, which is expressed in Nw. per shear rate:

Q = F_t × V_c

Q is heat.

F_t shear force in Nw V_c speed in rpm.

The heat generated is the same for all three techniques if we keep the V_c speed proportional to the cutting force.

The single drill technique, a variation of the Brånemark technique, utilizes a drill with macromorphology to bypass intermediate steps, thereby reducing infection risk and improving the micromorphology of the implant osteotomy.

Biological milling (50 rpm without irrigation) takes more time, increases the risk of infection and results in no temperature difference.

All three techniques are influenced equally by bone quality (cortical thickness, cancellous hardness and osteotomy depth).

In 1993, Bert found that temperature depends on cooling, intermittent milling, and rotation speed [32] , data which are supported by our study. Biological milling requires a cutting force greater than 50 Nw [33] . Therefore, the heat generated will be equal to 50 times 50, which is 2500 rpm. The heat generated is equivalent to that of sequential milling.

Tamburi discovered that cutting edge loss occurs after 20 uses, increasing friction and temperature [34] . The One Drill, which is coated with TRIMRITE steel, can be used at least 100 times before showing wear.

A bur must detail the cutting zone’s morphology (helical, straight, cross), attack angle, usage count, diameter, speed, and irrigation type for effective comparison.

The helical cutting zone is the most frequent (Brånemark), while the straight requires higher speeds (IMZ) to avoid oval osteotomy morphology, and the cross shape (BIS) enhances internal irrigation. Additionally, the cutter’s material affects temperature, with ceramic resulting in the highest and steels the lowest temperatures.

Another variable is the material from which the cutter is made: ceramic resulting in the highest temperature and steel the lowest (Figure 9).

T5 titanium wears more, but it prevents metallic contamination of the surgical site.

Increasing the angle of attack raises the likelihood of tip fractures, while decreasing the angle of attack increases wear. The angle of attack in One Drill cutters is set at 25 degrees, balancing axial and radial forces and requiring less cutting force (Figure 10).

The quality of the bone osteotomy surface and the volume of chips depend on the distance between the drill blades. The optimum distance is between 1.3 and 1.7 mm, with One Drill drills being 1.5 ± 0.3 mm (Figure 11).

If we increase the pitch distance, the quality of the bone surface deteriorates, and the durability of the cutter increases.

Not using irrigation raises the temperature, as previously published by Lemons [35] , stating, “the increase in temperature in biological milling is 4 degrees,” a finding supported by our study, which shows an even greater increase.

All three milling techniques maintain the temperature below the critical threshold, ensuring their validity in terms of temperature, provided the opposing factors of speed and cutting force are compensated for. The higher the wear, the lower the speed and cutting force [36] .

The professional’s manipulation influences two factors: bone-drill contact time (Brånemark established it at 5 - 6 sec) and the pressure exerted. As these measurements increase, the temperature increases.

The study of the osteotomy morphology was approached indirectly, and no statistically significant difference was observed among the three techniques with regard to the percentage of implant survival during the first three months (primary ossification).

The only statistically significant difference was the time necessary to perform the osteotomy, with the One Drill technique producing the best results.

The “ONE DRILL, ONE IMPLANT” protocol of the manufacturer One day Biotech is simple, ergonomic and reliable, with no risk of causing temperature increment above the tolerable limits.

The primary osseointegration rate exceeds 99% of cases and allows implant insertion with 30 to 50 Nw, guaranteeing primary stability in all types of bone. The manufacturer provides a detailed protocol that must be followed.

One Drill burs are made of Trimrite-coated stainless steel, which increases the resistance of the bur and decreases its wear, reducing the increase in temperature due to friction.

All instruments are organized in the “One Drilling Kit”. The initial step involves using the pilot drill, also known as the “Guide Drill”, to mark the osteotomy’s center. The osteotomy is completed with the “One Drill” which matches the implant’s diameter. The depth is controlled by a stopper that aligns with the implant’s length.

In Type 1 bone or with a cortical thickness greater than 3 mm, the Countersink is used after completing the osteotomy to widen it for implant insertion. Twist Drill drills should be reserved for extremely hard Type I bones.

The advantages of the single drill technique include shorter time, lower temperature increase, lower infection risk, and greater osteotomy uniformity.

The biological technique offers no benefits and increases execution time, infection probability, and the risk of exceeding critical temperature limits.

The sequential technique is very time-consuming, especially when drilling for 4 implants in the same patient session.

The volume of bone harvested using the One Drill technique or the biological drilling technique did not show statistically significant differences, according to Hyun-Chang Lim [37] . With the larger diameter drill, 0.13 cm of autologous bone was ready to be used in guided tissue regeneration. Similarly, Manzano-Moreno [38] measured the bone harvested with helical drills and during biological drilling. In our study, as in Manzano-Moreno’s findings, there is a statistically significant difference in the volume of autologous bone harvested between sequential drilling and the One Drill technique, with no significant difference between biological drilling and the One Drill technique.

The size of the bone chips depends on the drill’s angle of attack rather than the technique used. With One Day Biotech’s One Drill technique, their size ranges between 350 and 550 microns, which is ideal for use in RTG (Figure 12).

The primary stability of the implant, measured using insertion torque and the ISQ, shows no statistically significant differences across the three techniques. Meridith measured the AFR, while Bavetta [39] and Levin [40] measured the ISQ, defining osseointegration of an implant as having a value between 57 and 82. Sannerby (2008) identified failure for a Brånemark implant if its value was below 55, and below 45 for a Strauman implant. Stephan F [41] recommends immediate loading only if its value exceeds 60. In our study, the values ranged from 57 to 81.

Osseointegration at twelve weeks did not show statistically significant differences, coinciding our study with the work of Toyoshima [42] (Figure 13).

4. Conclusions

1) The lowest temperature rise is achieved with the One Drill technique.

2) Surgical time is also shorter with a statistically significant difference for the One Drill technique. When comparing the techniques based on temperature increase, time used, risk of infection, and ergonomics, the One Drill technique scores the highest, while biological drilling scores the lowest.

3) None of the three techniques exceeds the critical limit of 47 degrees, making them safe for use in implantology practice.

4) Regarding the volume of autologous bone harvested, there is no statistically significant difference between the One Drill and biological drilling techniques, both of which are significantly superior to the classic Brånemark technique or “sequential drilling.”

5) No statistically significant differences were found between bed preparation techniques and the percentage of osseointegrated implants at 8 weeks.