J Oral Maxillofac Surg 68:2299-2306, 2010

Flapless and Traditional Dental Implant Surgery: An Open, Retrospective Comparative Study
Paul Rousseau, MD*
Purpose: Osseointegrated dental implantation is traditionally performed by a ap approach that

involves soft tissue ap reection, but this technique is associated with several drawbacks. Conversely, the apless method requires only minimal removal of soft tissue but is not suitable for all patients. The objective of this study was to compare the apless (FL) method of implant placement with the traditional ap (TR) method with regard to achievement of success, change in bone level, and overall safety. Patients and Methods: In this single-center, open, retrospective, investigator-driven, nonrandomized, comparative study, patients were pre- or intraoperatively assigned to the FL or TR treatment. The primary success criteria were the absence of mobility, radiolucency, pain, and infection. Results: The FL method was applied to 174 implants (46%) in 121 patients and the TR method to 203 implants (54%) in 98 patients. At visit 1, implantation was rated successful in 171/174 (98.3%) implants with the FL method and in 200/203 (98.5%) with the TR method. Success rate remained constant until visit 2. The difference between the 2 groups in the rate of success was not signicant. Similarly, no signicant difference was observed for mean time to last follow-up for success. Conclusions: Based on pre- or intraoperative decision-making, patients eligible for FL surgery can benet from a less straining procedure without affecting the high success rate of dental implant surgery. The FL approach is a predictable procedure when patient selection and surgical technique are appropriate. 2010 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 68:2299-2306, 2010 Osseointegrated dental implantation is traditionally performed by a ap approach that involves soft tissue ap reection and necessitates the introduction of sutures after implant placement. The procedure can be performed in 1 stage or 2 stages, whereby the mucosal ap acts to prevent bacterial infection and minimize micromotion.1-3 Numerous studies have shown that the ap approach, with or without immediate loading, can be successful and is associated with good results.4-6 However, despite the long-standing and successful use of the ap approach for the surgical placement of dental implants, this approach is associated with several drawbacks. Chief among these is a loss of alveolar crest bone due to decreased supraperiosteal blood supply because of raising the tissue ap during the surgical procedure.7-9 Additional concerns include postoperative blood loss and hemorrhage, esthetically displeasing soft tissue recession (including papillae), and pain and discomfort for the patient.10-13 To address these main concerns, alternative methods to the ap approach have been sought in recent years. To this end, apless surgical approaches have been developed that can provide function, esthetics, and comfort with minimally invasive surgery. Flapless methods involve a 1-stage approach that requires only minimal removal of soft tissue and involves the introduction and gradual widening of an osteotomy and placement of the implant.14,15 Thereafter, the implant can be immediately loaded with the prosthesis, or a healing abutment can be inserted until loading at a later date, depending on individual circumstances and patient and clinician preferences.10,11 However, to use the potential advantages of a apless approach, there are certain prerequisites that surgeons must be aware of before performing apless surgery. The method is only suitable for patients with sufcient alveolar bone height, volume, and density and adequate or augmentable attached gingiva, especially keratinized gingiva.16

*Consultant, Department of Oral Surgery, Chirurgie Orale, Paris, France. Address correspondence and reprint requests to Dr Rousseau: Department of Oral Surgery, Chirurgie Orale, rue Dupont des Loges 5, 75007 Paris, France; e-mail: walter.fuerst@archimed.ch
2010 American Association of Oral and Maxillofacial Surgeons

0278-2391/10/6809-0038$36.00/0 doi:10.1016/j.joms.2010.05.031

2299

2300 The ap and apless techniques can produce successful results, conforming to traditionally used success criteria, such as those by Albrektsson et al17 and those by Schnitman and Shulman18 from an earlier consensus conference. Both sets of success criteria underscore the concept that impaired osseointegration is the most important factor affecting long-term dental implant attachment. In light of the various pros and cons of each of the 2 techniques, it was considered potentially useful to compare the techniques in outcomes and potential advantages using retrospective data from patients in a single center. The objective of this study therefore was to compare the apless method of surgical implant placement (FL) with the traditional ap method (TR) primarily with regard to achievement of success, dened as absence of mobility, absence of radiolucency, absence of pain, and absence of infection. Change in bone level and overall safety represented secondary parameters evaluated in this study.

FLAPLESS AND TRADITIONAL DENTAL IMPLANTATION IMPLANTS

The TR surgery (ap group) was performed according to the implant manufacturers recommendations. All implants used were of the Straumann Dental Implant System (Insitut Straumann, Basel, Switzerland). The types of implant included sandblasted and acidetched soft tissue regular neck (neck diameter, 4.8 mm), wide neck (neck diameter, 6.5 mm), and narrow neck (neck diameter, 3.5 mm) implants. The implants used had diameters of 3.3, 4.1, and 4.8 mm (Table 1).
EXAMINATION SCHEDULE

Patients and Methods

PATIENTS

The distance between the mesial and distal implant shoulder and the rst visible bone-implant contact (DIB) in each patient was assessed at the time of implantation. Patients were recalled at 4 weeks after implantation for assessment of implant mobility. The rst follow-up visit (visit 1) took place 2 to 3 months after implantation and was always before loading of the implant. The second follow-up visit (visit 2) took place 2 years after implantation.
SURGICAL PROCEDURES AND RADIOGRAPHS

All patients who required dental implantation and who met the criteria for implantation were enrolled in the study. Patients were pre- or intraoperatively assigned to the FL or TR treatment group. Exclusion criteria were patients uncontrolled local or general diseases.
METHODS

This was a single-center, open, retrospective, investigator-driven, nonrandomized, comparative study.

METHOD SELECTION (TRADITIONAL VERSUS FLAPLESS)

The FL surgery was performed using a standard approach.14 After administration of minimal anesthetic (68 mg/1.7 mL of chlorhydrate articaine and adrenaline 1/100,000 for a maxillary quadrant), a circular incision in the gingival part of the alveolar crest was performed with a specic trephine until bone contact. The trephine diameter was 5 mm for regular neck implants (neck diameter, 4.8 mm), 6 mm for wide neck implants (neck diameter, 6.5 mm), and 4 mm if narrow neck implants (neck diameter, 3.5 mm) were placed. The mucosal block was removed, and the crestal bone was curetted. Thereafter, the bone morphology (direction of the vertical wall), bone den-

Sites of implantation suitable for the FL method were chosen by the investigator based on the width of keratinized gingival crest, ie, a minimum width of 2 mm had to remain on the buccal site after crestal circular incision. The bone was evaluated from periapical radiographs using the long-cone technique. After assessment, the investigator decided pre- and intraoperatively whether the FL method could be applied for a particular site of implantation. For areas where implant placement was planned some time after tooth extraction, the decision of whether the FL method would be used was based on examination of the mucosal healing conditions, and bone density was evaluated from periapical radiographs using the long-cone technique. On rare occasions an osteogenesis defect was apparent, which rendered the site unsuitable for FL surgery. In these cases the site was assigned to receive the implant by the 1-stage ap surgery approach.

Table 1. IMPLANT AND PROSTHESIS CHARACTERISTICS

Implant Characteristic Length of implant (mm), n (%) 8 10 12 14 Diameter of implant (mm), n (%) 3.3 4.1 4.8 Type of prosthesis, n (%) Single crown Partial Full denture

Flapless 50 (28.7) 78 (44.8) 45 (25.9) 1 (0.6) 41 (23.6) 69 (39.7) 63 (36.2) 142 (81.6) 22 (12.6) 7 (4.0)

Traditional 35 (17.2) 80 (39.4) 81 (39.9) 7 (3.4) 41 (20.2) 118 (58.1) 42 (20.7) 109 (53.7) 93 (45.8) 1 (0.5)

Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

PAUL ROUSSEAU

2301
STATISTICAL ANALYSES

sity, and crestal bone width were determined with a periodontal probe. In case of doubt regarding the exact position of the buccal bone wall (eg, if a blade or knife morphology was observed), the bone position was assessed with a probe inserted horizontally through the mucosa at a level corresponding to the expected position of the implant apex. Thereafter, the drilling and implant installation were performed; the implants were therefore encased in bone as much as possible.
PRIMARY AND SECONDARY SUCCESS CRITERIA

Descriptive Statistics Descriptive statistics were applied for continuous data, and nonparametric methods were applied for categorical data and non-normal distributions. Descriptive statistics for continuous data included the mean, median, standard deviation, and the range of values (minimum, maximum). Descriptive statistics applied to nominal and ordinal variables included the number and percentage per group. Kolmogorov-Smirnov tests were performed for normally distributed continuous data. Comparative Statistics Whenever applicable, parametric tests were applied. If not normally distributed, categorical data were compared using nonparametric methods including Fisher exact test, Pearson 2 test, and Mann-Whitney U test for 2 independent samples. Bivariate nonparametric correlations (Kendall -b) were assessed with a signicance limit set at P less than .05. Withingroup comparisons were examined with the Wilcoxon signed rank test or Friedmann test. Comparisons were assessed with 2-sided tests and P less than .05 indicated statistical signicance, whereas P values of .05 to less than .1 were predened to indicate a trend.

The primary success criteria were absence of mobility (assessed manually by the physician), absence of radiolucency (assessed by periapical radiography using the long-cone technique), absence of pain (as reported verbally by the patient), and absence of infection (assessed manually by the physician). The sole secondary success criterion was change in the DIB. This was measured (in millimeters) at the mesial and distal aspects of each implant using periapical radiographs with the long-cone technique.19
DATA RECORDED DURING SURGERY AND AT FOLLOW-UP EXAMINATIONS

Data recorded at the time of surgery included the date of surgery; indication for implantation (single crown, xed partial denture, or full prosthesis); and implant details, including the position, diameter, length, and type of implant. Parameters measured at the time of surgery included stability of the implant, bone quality according to the criteria of Lekholm and Zarb,20 complications, mobility, and mesial and distal DIBs for each implant. Bone quality types according to Lekholm and Zarb include almost homogenous compact bone (type I), thick compact bone surrounding a core of dense trabecular bone (type II), thin cortical bone surrounding a core of dense trabecular bone (type III), and thin cortical bone surrounding a core of low density trabecular bone (type IV). Parameters measured at visits 1 and 2 included mobility, radiolucency, complications such as infection or pain, and mesial and distal radiographic DIBs.
ZONE DESCRIPTIONS

Results
PATIENT CHARACTERISTICS AND FOLLOW-UP

Two hundred eighteen patients requiring 377 implants were treated in this study. Ninety-three were men (42.7%), and 125 were women (57.3%). Mean patient age was 54.3 12.6 years (range, 23 to 84 years; Table 2). None of the patients presented any risks contraindicating implant placement.

Table 2. PATIENT CHARACTERISTICS

Patient Characteristic Male/female, n/n (%/%) Age (yr), mean SD Time between visits (d), mean SD Implantation to visit 1 Implantation to visit 2 Visit 1 to visit 2 Bone type,* n (%) I II III IV

Flapless 46/75 (38/62) 54.0 13.5 118.4 101.4 812.0 198.4 702.7 217.1 16 (9.2) 45 (25.9) 83 (47.7) 30 (17.2)

Traditional 47/50 (48/52) 54.9 11.5 126.7 94.9 812.2 258.9 685.5 270.3 12 (5.9) 52 (25.6) 89 (43.8) 49 (24.1)

Implants from the FL group were matched to implants from the ap group by zone. The mouth was divided into 6 zones (3 per jaw) corresponding to left-sided, central, and right-sided mandibular implants and left-sided, central, and right-sided maxillary implants.

*According to criteria of Lekholm and Zarb.20

Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

2302 The FL method was applied to 174 implants (46%) in 121 patients and the TR method to 203 implants (54%) in 98 patients. One patient received an implant by the FL and TR methods and for statistical analyses was therefore counted in both study groups when stratied by method but only once in the overall statistics. The overall mean number of implants per patient was 1.7 1.1 (SD). The mean times from implantation to visit 1, from implantation to visit 2, and from visit 1 to visit 2 were similar for the 2 treatment groups (Table 2). The broad range in time between visits is due to the inclusion of 1 patient who received implants with immediate loading.

FLAPLESS AND TRADITIONAL DENTAL IMPLANTATION IMPLANT CHARACTERISTICS

Patients in the FL group received signicantly shorter implants (P .002) compared with patients in the TR group (Table 1). Patients in the TR group received signicantly more (P .002) implants of diameter 4.1 mm (Table 1). Most prostheses in both groups were single crowns. Partial dentures were more frequent in the TR group than in the FL group and full dentures were much more frequent in the FL group (Table 1). In the maxilla, the number of implants placed by the FL method exceeded the number of implants placed by the TR method in zones 4/5 and 6/7; in zones 13 to 23 more implants were placed by

FIGURE 1. Distribution of implants by position with the apless (purple bars) and traditional ap (red bars) surgical techniques. A, Implants placed in the maxilla. B, Implants placed in the mandible. Data labels indicate the number of implants placed in the respective zones of patients in each study group. Max Ant, maxilla anterior; Max Molar, maxilla molar; Max PM, maxilla premolar; Mdb Ant, mandible anterior; Mdb Molar, mandible molar; Mdb PM, mandible premolar. Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

PAUL ROUSSEAU

2303 Bone Level The mean increases in mesial DIB in the FL and TR treatment groups from the time of implantation to visit 2 (0.38 0.83 and 0.22 0.57, respectively) and from visit 1 to visit 2 (0.19 0.70 and 0.01 0.45) were signicantly greater in the FL compared with the TR treatment group (P .025 and P .002, respectively; Table 4). In addition, the mean increase in distal DIB from visit 1 to visit 2 (0.18 0.66 and 0.01 0.43 for the FL and TR groups, respectively) was signicantly greater in the FL group (P .004). Changes in bone levels inversely correlated with preoperative levels. These changes until visit 2 were more pronounced in the FL compared with the TR group.

the TR method (Fig 1A). In the mandible, the number of implants placed in zones 33 to 43 was small (2 implants, 1.7% and 2.0% for the FL and TR groups, respectively) in both groups (Fig 1B). In zone 6/7 of the mandible, more than two thirds of implants were placed by the FL method.
EFFICACY

Success At visit 1, implantation was rated successful in 171/ 174 (98.3%) implants with the FL method and in 200/203 (98.5%) with the TR method. The success rate remained constant until visit 2. The difference between the 2 groups in the rate of success was not signicant. Similarly, no signicant difference was observed for mean time to last follow-up for success (Kaplan-Meier method; Fig 2). The mean times to last follow-up for success were 780.6 19 days with the FL method and 812.1 18.4 days with the TR method. Key steps of implant placement are illustrated in Figure 3. Individual Measurements of Success Mobility and radiolucency were absent for both methods and at all time points assessed. Complications were reported after 3/174 FL and 3/203 TR procedures (Table 3). Pain was reported for 1/174 and 2/203 implants after FL and TR surgeries, respectively. The healing cap became detached in 2 patients in the FL group and 1 postoperative infection was reported for a patient with TR treatment. There were no signicant differences between study groups for any of the individual success parameters.

Discussion
The FL surgery and TR dental implant surgery were associated with high success rates above 98% in this study of 377 implants in 218 patients. Outcomes in terms of efcacy and safety did not differ signicantly between implants placed with the FL and TR approaches. Of note, the choice of treatment depended on patient and site characteristics and was made intraoperatively for some patients. Therefore, a prospective randomization to either treatment group was not possible. The results of this study are very much in line with those of other studies with regard to the rate of success of implant placement. For example, Becker et al21 reported a success rate of 98.7% at 2 years after implantation for 79 implants in 57 patients who were treated with the FL approach. Similarly, al-Ansari and Morris14 reported a 100% success rate with no complications using the FL technique for the placement of 20 implants. Campelo and Camara,8 in a retrospective analysis of FL implant surgery, also reported a 100% success rate for the placement of 91 implants. Patients in the FL group presented with lower DIB at the time of implant placement compared with those in the TR group. Patients in the FL group also exhibited signicantly greater increases in DIB from implant placement to visits 1 and 2 compared with patients in the TR group. Due to being installed blindly, the implant is installed more deeply with the FL technique than with the TR technique. Therefore, a portion of the transmucosal (supracrestal) part of the implant is slightly below the crestal bone level. Because the coronal part of the implant is smooth titanium, rearrangement of bone around the neck of the implant is normal. After healing and loading, it is common to observe that the bone level reaches beyond the rough titanium surface. When a TR technique is used, the implant is installed under visual control directly at the right crestal bone position. This

FIGURE 2. No signicant difference in time to success (KaplanMeier curve) was observed between the FL and TR groups (P .46, log-rank Mantel-Cox test). Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

2304

FLAPLESS AND TRADITIONAL DENTAL IMPLANTATION

FIGURE 3. Representative images of key steps in implant placement by the apless and traditional ap methods. A, Usual buccal bone resorption underlined by the gingival shape. B, Flap moved buccally to achieve an ideal mucosal prole. C, To achieve an ideal placement with the apless technique, a precise width of keratinized gingiva is required. D, Subsequently, the implant must be placed on the center of the crown. E, For an optimal esthetic result, the buccal crown proles should be tangential to each other. Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

results in less bone rearrangement around the implant neck. Success in dental implantation can be evaluated using various criteria, and the most widely used are those proposed by Albrektsson et al17 (Table 5).

These criteria are based on, and very similar to, the recommendations of an earlier consensus development conference that are also widely used for the evaluation of successful implantation.18 The criteria

Table 4. CHANGE IN BONE LEVEL Table 3. COMPLICATIONS

Number of Cases Flapless Total Pain Detachment of healing cap Traditional Total Pain Infection 3 1 2 3 2 1

Change in Radiographic Level, Mean SD Mesial Implant placement Implant placement Visit 1 to visit 2 Distal Implant placement Implant placement Visit 1 to visit 2

Flapless

Traditional

to visit 1 0.18 0.46 0.17 0.32 to visit 2 0.38 0.83 0.22 0.57 0.19 0.70 0.01 0.45 to visit 1 0.14 0.43 0.18 0.32 to visit 2 0.33 0.80 0.21 0.55 0.18 0.66 0.01 0.43

Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

PAUL ROUSSEAU

2305 crown face. Therefore, the bone prole and by implication the soft tissue prole are more important than the width of the bone in evaluating the suitability of FL surgery. Preoperative preparation is a critical component of the successful placement of implants using the FL method. Careful examination and diagnosis of the implant site, with radiographic assessment, is mandatory. Preoperative preparation may also include the use of computer tomography and sophisticated diagnostic software and the fabrication of a surgical template with a drilling guide for each implant.8,11 There is a learning curve with every surgical procedure, after which it becomes routine, and the experience of physicians in performing FL implant surgery is therefore an important factor in the likelihood of successful placement. This is evident when one looks at the success rate of FL implant surgery over the course of 10 years, from 1990, when the technique was still relatively new, up to 2000. Over this 10-year period, the success rate of the procedure increased considerably, from only 74.1% in 1990 to 100% in 2000.8 In addition to adequate experience, surgeons should be knowledgeable of the indications and techniques used for management of peri-implant tissues, including soft tissue maneuvers and augmentation. In conclusion, based on pre- or intraoperative decision-making, patients eligible for FL surgery can benet from a less straining procedure without affecting the high success rate of dental implant surgery. The FL approach is a predictable procedure when patient selection and surgical technique are appropriate. The surgeon needs to decide whether the FL technique is to be used for implant placement depending on the quantity and, above all, morphology of the bone and soft tissue anatomy into which the implant is to be placed, and based on his or her own experience and technique.

Table 5. SUCCESS CRITERIA OF ALBREKTSSON ET AL,17 1986

1 2 3 4

That an individual, unattached implant is immobile when tested clinically That a radiograph does not present any evidence or peri-implant radiolucency That vertical bone loss be 0.2 mm annually after the implants rst year of service That individual implant performance be characterized by an absence of persistent and/or irreversible signs and symptoms such as pain, infections, neuropathies, paresthesia, or violation of the mandibular canal That, in the context of criteria 1-4, a successful rate of 85% at the end of a 5-yr observation period and 80% at the end of a 10-yr period be a minimum criterion for success

Paul Rousseau. Flapless and Traditional Dental Implantation. J Oral Maxillofac Surg 2010.

used in this study were similar to those of Albrektsson et al but differed on 2 points: 1) bone loss was a secondary rather than a primary success criterion, and 2) long-term outcomes (at 5 and 10 years) were not considered. The prerequisites for FL surgery include various aspects of patient characteristics, preoperative preparation, and physician experience. Patient and site selection are primary concerns. Several investigators have proposed that patients should have a minimum of 4.5 to 5.0 mm of keratinized gingival tissue and at least 4 to 4.5 mm of alveolar bone width without undercuts larger than 15.22 Kan et al15 proposed an even more stringent 6-mm minimum alveolar ridge width. The wider bone requirement of the FL approach is due to the comparatively limited visibility that the physician has when operating and provides an extra margin of safety to avoid perforation of the lingual or buccal cortical plates.8 The bone shape prole is usually modied in a healing edentulous area. Therefore, in a sagittal view, the rst gingival contact with bone is more apical and more palatal than before the extraction of the root. Furthermore, the contours of the surrounding gingiva follow the modied bone prole. In a 1-stage ap surgery, it is possible to replace the keratinized tissue around the buccal and coronal neck of the implant. After this soft tissue replacement, the desired esthetic outcome is achieved at the crown placement. When using the FL approach, the same esthetic result that would be obtained using the ap technique must be achieved. However, because soft tissue is not modied when using the FL technique, the soft tissue prole, and consequently the bone prole, need to have the ideal sagittal shape before implant placement. This means that the rst buccal bone point in a sagittal view must be at the tangent of the buccal

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FLAPLESS AND TRADITIONAL DENTAL IMPLANTATION

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