Ministry of Education & Training Ministry of National Defense 108 Institute of Clinical Medical & Pharmaceutical Sciences  VO VAN NHAN DENTAL IMPLANT PLACEMENT ON ALVEOLAR BONE GRAFTED PATIENTS AFTER CLEFT LIP AND PALATE RESCONTRUCTIVE SURGERY Specialty: Odonto - Stomatology Code: 62.72.06.01 PH.D THESIS SUMMARY Hanoi - 2014 THE RESEARCH WAS FINISHED AT 108 INSTITUTE OF CLINICAL MEDICAL & PHARMACEUTICAL SCIENCES Full name of scientific instructors: 1. Assoc.Prof. Ph.D. Le Van Son 2. Ph.D. TaAnh Tuan Judge 1:Assoc.Prof. Ph.D. Trinh DinhHai Judge 2: Ph.D. Le Hung Judge 3: Prof. Ph.D. Le GiaVinh The thesis will be defended before the Thesis Assessment Council at Institute level At , date month year Be able to search the thesis at: 1. National library 2. 108 Institute of Clinical Medical & Pharmaceutical Sciences Library 3 I. RATIONALE OF THE SUBJECT Cleft lip and palate (CLP) is the most frequently reported congenital birth defect in the cranio-maxilo-facial field. According to WHO, the overall incidence of cleft lip and palate is reported around 1/500 live births [138]. This incidence is different depending on regions and races:it’s low in the black and high in Japanese, Chinese and Indian-American. In Vietnam, this incidence is about 1/709 to 1/1000 [2], [7]. Around the world, some clinicians successfully applied implant treatment for cleft lip and palate patients like Verdi (1991) [139], Kearns (1997) [68],…. In Vietnam, the research on cleft lip and palate patients mainly assess epidemiology and cleft lip - palate closing technique [1], [3], [4], [5], [7], a few studies were takenabout alveolar bone graft such as study of Nguyen Manh Ha (2009) [6], or implant placement in normal patients without defects of Ta Anh Tuan (2007) [8]. Thus, the implant placement on the grafted bone and implant prosthetic on CLP patient is the problem that has not been studied comprehensively in Vietnam. Meanwhile, the demand for treatment is huge since most CLP patients have not had bone grafts and dental restorations as of yet. With the desire to implement the implant technique for CLP patients in Vietnam and perform a systematic scientific research, we conducted the thesis "Dental implant placement on alveolar bone grafted patients after cleft lip and palate reconstructive surgery". II. RESEARCH OBJECTIVES 1. Evaluate jaw bone condition after alveolar cleft bone graft 2. Evaluate the success of implant treatment. III. MEANING 4 The thesis provides a new treatment method for patients with cleft lip and palate defect, not only torecoverthe function but also to meet the aesthetic demand helping patients communicate confidently for community integration. IV. THESIS STRUCTURE The thesis consists of 121 pages, not including appendices and references. The contents of the thesis are: Introduction (2 pages), Literature review (31 pages), Research subjects and method (29 pages), Research results (20 pages), Discussion (36 pages), Conclusion (2 pages), Recommendations (1 page). The thesis has 23 tables, 4 diagrams, 12 charts, 69 pictures, 144 references (9 Vietnamese, English 135). Chapter 1: LITERATURE REVIEW 1.1.CLEFT LIP AND PALATE Cleft lip and palate are birth defects causing deficiency and deformities of the nose, lips, palate that affects the formation of unerupted tooth, teeth eruption, malocclusion, mastication, distortion of the mesial floor and inferior floor of the facial, pronunciation, the aesthetic and psychological diseases [94], [65]. Therefore, those who suffer from this malformation always feel inferior andcan feel distance from community. The treatment of CLP defects is a long process from the child still in the womb to anadult with the cooperation of many experts and various techniques including psychological counselling, primary lip and palate repair surgery, alveolar cleft bone graft surgery, orthodontic treatment, dental restorations, [101], [106]. 1.2.ALVEOLAR CLEFT BONE GRAFT 5 1.2.1. The necessity of alveolar cleft bone graft Alveolar cleft bone graftingprovides room for orthodontic movement of the teeth in the position of #3 and #2 (canine and lateral incisor) to erupt into the cleft or for dental prosthesis, maintain bony support of teeth adjacent to the cleft, preserve the health of the arch and facilitates closing of the fistula in the secondary bone grafting [138]. 1.2.2. Flap preparation forgrafted recipient Flap designs in alveolar cleft bone graft surgery are extremely important to determine the success of the surgical procedure as it provides adequate soft tissue for the closure over the bone graft without flap tension and dehiscence. There are many flap design techniques such as thelateral sliding flap, the oblique sliding flap, the buccal finger flap, the nasal lining flap and the palatal flap [18].The flap designs can be used by single or multiple techniques, depending on the clinical situation for optimaltension- free closure. 1.2.3. The choice of donor site for graft material Autogenous bone can be taken from many different sourcesin which the tibia is first used, followed by iliac crest, ribs, chin and calvarial bone (SindetPerdersent and Enermark 1988) [116]. Some authors have done a lot of research in order to replace the autogenousbone material in alveolar bone grafting,such as with demineralized freeze-dried bone combined with iliac cancellous bone of Steven (2009) [121], β Tricalxium-phospate (TCP) of Ruiter (2012) [107] or BMP-2 (bone protein) of Dickinson (2008) [39] but studies using these materials is still not advancedand is not commonly applied. Therefore,autogenousgrafted bone is still 6 considered as the golden standard for graft material of alveolar cleft recovery.Ananth’s research (2005) summarized 110 centers with 240 CLP surgical teams, which showed iliac crest bone is still the most popularmaterial used by 83% [19]. 1.2.4. Techniques of placing grafted bone There are many techniques in placing the grafted bone in the cleft such as iliac crest cancellous bone graft [46], iliac crest bone block graft [31], autogenous bone graftwithartificial membrane barriers covering graft material [100], the use of a cortex bone plate (CBP) along the lining of thepalatal suture line[85] and lateral corticalbone plates from the symphysis[127]. But so far, these techniqueshave not been commonly used in alveolar cleft bone grafting. 1.2.5. Evaluation methods of bone graft result 1.2.5.1. Means of evaluation Some authors evaluate the results of bone graft by histology [60] but the most popular is still by computed tomography, including periapicalradiography, occlusalradiography, panoramic radiography, conventional CT and Cone Beam CT. The results of alveolar cleft bone graft was previously mainlyassessed by periapicalradiography and occlusalradiography[46], [54], [55], [72], [81] but these films did not measure the buccal-lingual distance of the graft [77]. Therefore, Cone Beam CT today has become popular and useful in assessing changes in volume and size in 3-dimension[59], [137]. 1.2.5.2. Evaluation scale Nowadays, for the assessment of the alveolar bone graft outcome, most of thestudies usethe combination of two-dimensional film 7 Figure 1.16:Enermark scale[42] (periapicalradiography and occlusalradiography) through the evaluation scale of the bone bridge formation in the cleftand CTCone Beam to examine the 3-dimensional size or volume of the graft [24], [26], [61], [79], [128], [137]. Several scales are applied such asEnermarkscale (1987) [42], Berglandscale (1986) [24] using periapical radiographyand Kindelanscale (1997) [71] using occusal radiographyto assess the bone heightbetween the teeth in the cleft areas, successful results was obtained when more than 50% bone fill in the cleft areas (Figure 1.16). Thesescales are popular because it is easy to apply in comparison with Long scale [81] and Witherow scale [140]. 1.3.DENTAL IMPLANT Osseointegratedimplant that was developed by professor Branemark in the 1960s has now becomeconventional treatment method to restore the missing teeth as well as congenital teeth deficiency in CLP patients. In 1991, Verdi [139] reported a first case of successful alveolar bone grafting and implant treatment, then followed by some reports of implant treatment in similar situation as Fukuda (1998) [50], Kearns (1997) [68], Lilja (1998) [79], Takahashi [130], [131], Implants have the supported fixationcomponent whichauthors have developed many flexible solutions for implant prosthesesfor various and complex situations of CLP patients after alveolar cleft bone grafting. However, most of the above studies have evaluated the success of implant osseointegration, not the aesthetic of implant prostheses. Chapter 2: RESEARCH OBJECTS AND METHOD 1.1.Research subject 8 - Patient selection criteria: Patients over 15 years old, in good health for endotracheal anesthesia, already has had palatoplasty, complete unilateral alveolar cleft, lack of permanent tooth germ in the cleft andhas not had any alveolar cleft bone graft. - Elimination criteria: No alveolar cleft, no unilateral or bilateral alveolar cleft.Patientswho disagree to participate in the research. 1.2.Research method 1.2.1. Research design: This thesis useda prospective uncontrolled clinical trial method to evaluate alveolar cleft bone graft outcomes and implant success. Sample size: 32 patients by the averageestimating formula. 1.2.2. Research time:August, 2010 to February, 2014. 1.2.3. Research procedure: Firstly, patient information was collectedwith a case history form. After orthodontic and general dental treatment, alveolar cleft bone grafting surgery was conducted with the technique of 2 iliac corticocancellousbone block autograft. 4 to 6 months later, the implant placement was performed; 6 months later, prostheses on the implant was executed.There was continued follow-up 15 and 18 months after the alveolar cleft bone grafting. 1.3.Surgical procedure 1.3.1. Iliac bone block harvesting surgery A5cm incision over the superior iliac crestwas made 1 cm from anterior superior iliac spine to prevent damage of the lateral femoral cutaneous nerves. Thesubcuticular structure and mucoperiosteumwas infiltrated and then dissection of the periosteumwas carried out to expose iliac bone. Ultrasonic piezotome device was used to make 4 cuts: the first cut of 4cm on the superior iliac crest away from the cortical bone in the 9 abdominal cavity of 0.5cm, the second and the third cuts with the length of 2cm were perpendicular to the first cut. The fourth cut was perpendicular to the second and the third cuts. These four cuts created a rectangle. A chisel was used to harvest the bone block including the cortical and cancellous bone with the size of 4 x 2 x 0.5cm 3 . Afterthat, hemostatic sponge was placed and 2 layer sutures were used:periosteum suture and subcuticular suture. The bone blocks were kept in a small stainless steel cup in saline for moisture preservation. 1.3.2. Alveolar cleft bone graft surgery: Flap design: The incision began at the edge of the cleft and wentover the cleft’s perimeter,divided the cleft into 2 parts, then went down to the alveolar crest, moved to the two sides ofthe teeth’s neck next to the cleft and thencontinued to follow the gingival contours to the distalof tooth #4 or #5 and upwardto the vestibularforming avertical incision. At the top of the vertical line, an incision was made with the vertical line ofangle 120° to easily slidethe flap to the lateral and downwardposition (Figure 2.28). After that, from the incision on the alveolar crest that stayed closely to the neck (lateral) of the two teeth adjacent to the cleft, the incision was continued along the gingival sulcus on the labial side to the teeth at the two sides of the cleft. The nasal flap closure began with the suture from the buccal to the labial at one side of the flap edge, then the dissection was continued from the labial to the buccal at the contralateral flap edge. Finally, the knot was made (Figure 2.29). Based on the bone grafting technique of two lateral cortical 10 bone plates from the symphysisby Tadashi Mikoya(2010) [127], we introduced two iliac corticocancellousblock grafting techniques in this study with the technical steps as follows: Figure 2.32: The bone block on the vestibular was secured by screws Figure 2.33: Wound closure Figure 2.31: The cleftwas nearly filled by cancellous bone Figure 2.29: Nasal flap closure Figure 2.30: The bone block on the nasal lining Figure 2.28: The incision for flap design on the vestibular Step 1: Placement of cortical bone plate on the labial (nasal) aspects of the alveolar process defect: The iliac bone block was cut into 2 blocks. The first corticocancellous block with the size of the cleft size was placed on the sutured nasal mucoperiosteum (Figure 2.30). The cancellous bone was added on the plate until it nearly filled the cleft (Figure 2.31) Step 2: The second corticocancellous block with a larger size than the cleft was placed on the grafted cancellous bone covering the whole cleft and secured by screws for a tight fixation(Figure 2.32). Step 3: The wound closure: the palatal mucoperiosteumandthe vestibular mucoperiosteum wereclosedby the suture on the alveolar crest. Vestibular mucoperiosteum wassutured onboth sides of the cleftfrom the ridge of the alveolar crest towards thevestibular recess. The suture was continuedto recover the sulcus gingiva of the tooth from the cleft area. Finally, mucosa closure was made with the vertical tension-freeincision from the vestibular recess towards thealveolar crest (Figure 2.33). [...]... Jourmal of 108 Clinical Medicine and Pharmacy, Volume 2, pp.54-58 2 VõVănNhân (2014), “Kỹthuậtghéphaimảnhxươngvỏmàochậutrongphụchồikhehởh uyệtrăng ở bệnhnhânkhehởmôivàvòmmiệng”, Jourmal of 108 Clinical Medicine and Pharmacy, Volume 3, pp.95-99 3 TạAnhTuấn, VõVănNhân “Ghépxươngkhốitựthântrênbệnhnhântiêuxương (2013), ổ rănghàmtrên”, Jourmal of Viet Nam Medicine and Pharmacy, Volume 2, pp.87-90 ... results of theimplant on grafted bone and comparethe results of implant inother areas 3 Recommend producing anaesthetic evaluation criteria of dental restorations on implants for patients with cleft lip-palate LIST OF PUBLISHED RESEARCH RELATED TO THE THESIS 1 VõVănNhân (2014), “Cấyghép implant ở bệnhnhânkhehởmôivòmmiệng”, Jourmal of 108 Clinical Medicine and Pharmacy, Volume 2, pp.54-58 2 VõVănNhân (2014),... formation enable for implant placement 3 clefts (9.4%)showed insufficient bone for implant placement which indicated fixed bridge restorations 9,4%% 0%% 3.3 Result of implant placement 16 - Total of 32 implants were placed, of which 31 implants were of size 3.8 x 10mm and 1 implant was 3.8 x 12mm Of 32 patients, 3 patients had 2 implants placed, 26 patients had 1 implant placed - Initial implant stability:...11 1.3.3 Implant placement surgery and implant prosthodontics + Implant placement in the aesthetic zone [29]: Using implant surgical guide to ensure: Implant direction passes the occlusal edge of the further prostheses;In the buccal-lingual dimension, the buccal side of the implant is 2mm from the buccal side of the cortex;In the apical-coronal dimension, the implant shoulderis a distance... wereviable for implant placement Thus, the grafting technique of 2 iliac corticocancellousblock have contributed a new method showing good results in alveolar 26 cleft bone graft surgery for implant placement in cleft lip and palate patients 2 Result of implant placement + In terms of implant osseointegration: 100% of implant survival were in good function and no implant failures, in which 96.9% implant success,... implant, the processed implant surface and more thread in the implants neck area which helps increase the contact area between bone and implant surface; Implant placement were performed 4 to 6 months after bone graft that the mature graft were obtained and bone resorptionhad not yet happened too much compared to studies with increasedduration from bone graft to implant placement [131]; Implant with standard... prostheses on implant at9 and 12 monthsafter implant placement(n=32) Point of times Post bone graft surgery Post implant surgery Esthetic result of prostheses on implant Esthetical Clinical Esthetical success acceptance Total failure 15 9 18 5 9 32 months months (56.3%) (15.6%) (28.1%) (100%) 18 12 18 5 9 32 months months (56.3%) (15.6%) (28.1%) (100%) In the follow up of 9 and 12 months after implant placement,... (27.6%) satisfied and no patients disappointedwith their prostheses on implants (Table 3.33) Table 3.33: Result of the degree of patient satisfactionof the prostheses on implantafter9 and 12 months after implant placement (n=29) Point of time Post bone graft surgery Post implant surgery Patient satisfaction of the prostheses on implant Above satisfied Satisfied 15 9 21 months (72.4%) 12 21 8 months... months, 96.9% (31 implants) were successful, 3.1%(1 implant) appearingwith 2mm bone loss making it become satisfactory 17 survival, no implant failure The total survival of implants in good function were still 100% The survival rate at the point of 12 and 15 months had no significant difference compared to the point of 18 months (p . study of Nguyen Manh Ha (2009) [6], or implant placement in normal patients without defects of Ta Anh Tuan (2007) [8]. Thus, the implant placement on the grafted bone and implant prosthetic. (Figure 2.33). 11 1.3.3. Implant placement surgery and implant prosthodontics + Implant placement in the aesthetic zone [29]: Using implant surgical guide to ensure: Implant direction passes. placed, of which 31 implants were of size 3.8 x 10mm and 1 implant was 3.8 x 12mm. Of 32 patients, 3 patients had 2 implants placed, 26 patients had 1 implant placed. - Initial implant stability: