Summary of PHD thesis Odontostomatology: Clinical outcomes after surgical treatment of chronic periodontal with enamel matrix derivatives -Emdogain

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With the following goals: Comment on clinical, X-ray of stage IV chronic periodontitis according to AAP of a group of patients at Hanoi Central Odontostomatology Hospital from 2016-2019; Evaluation of surgical treatment results for chronic periodontitis using enamel matrix derivatives - Emdogain on the control group of patients.

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Nội dung Text: Summary of PHD thesis Odontostomatology: Clinical outcomes after surgical treatment of chronic periodontal with enamel matrix derivatives -Emdogain

MINISTRY OF EDUCATION AND MINISTRY OF TRAINING HEALTH HANOI MEDICAL UNIVERSITY DONG THI MAI HUONG CLINICAL OUTCOMES AFTER SURGICAL TREATMENT OF CHRONIC PERIODOTAL WITH ENAMEL MATRIX DERIVATIVES- EMDOGAIN Specialty : Odontostomatology Number : 62720601 SUMMARY OF Ph.D. THESIS HANOI - 2021
THIS RESEARCH WAS PERFORMED AT HANOI MEDICAL UNIVERSITY Supervisors: 1. Prof. Trinh Dinh Hai 2. Ph.D. Nguyen Thi Hong Minh Reviewer 1: Assoc. Prof. Dr. Pham Thi Thu Hien Reviewer 2: Assoc. Prof. Dr. Le Thi Thu Ha Reviewer 3: Assoc. Prof. Dr. Tong Minh Son Thesis will be defended in front of the University Thesis Evaluation Council Organized in Hanoi Medical University At , on , 2021 This thesis can be found at: 1. Vietnam National Library 2. Library of Hanoi Medical University
PUBLISHED RESEARCHES THAT ARE RELEVANT TO CONTENT OF THIS THESIS 1. Dong Thi Mai Huong (2020). Clinical Outcomes After Sugery Treatment Of Chronic Periodotal With Enamel Matrix Derivatives- Emdogain. Medical Research Journal, 132 (8). 45-54. 2. Dong Thi Mai Huong, Trinh Đinh Hai, Nguyen Thi Hong Minh (2020). Clinical, X-Ray Characteristics And Treatment Results Of Chronic Periodontis Surgery. Medical Research Journal, 135 (11). 197-204.
1 A. INTRODUCTION RATIONALE OF THIS THESIS Periodontitis is a common disease of the Odontostomatology. The disease occurs in all ages, and countries all over the world, accounted for a high proportion in the community and of a social nature. In the USA, research by Walter et al showed that the rate of periodontitis in the community is 25-41%. In Vietnam, according to the 2001 National Oral Health Survey, the percentage of people with gingivitis and periodontitis up to 90%, of which the rate of people with periodontitis at the age of 35- 44 is 36.4%; at the age of 45 and over is 46.2%. Up till now, the treatment of periodontitis is still facing many difficulties because of the complication of the disease and their pathogenesis, there is no specific treatment, but treatment for periodontitis includes a complex treatment consisting of many methods. In which there are two main methods are conservative treatment and surgical treatment. Periodontitis conservative or non-surgical treatment is a complex treatment, it offers good results for early periodontitis with periostal sac less than 5mm. Periodontitis with a pocket around the tooth over 5mm must be combined with surgical treatments to eliminate inflammatory factors, necrotic tissues, prevent the inflammatory process and reduce the depth pocket. In addition, periodontal surgery also regenerates tissue around the teeth with good results to restore the function and aesthetics of the patient. One of the purposes of periodontitis treatment is to restore damaged tissue. The proteins of Enamel Matrix Derivatives, which are formed from the Hertwig epithelium at the time of root formation, create a mutual action of the cell to form cement, especially the noncellular cement and then to form attachment fibers. In the treatment of periodontitis the proteins are beneficial to stimulate the regeneration of these tissues, direct the healing to the formation of new cement, functional new adhesion and new bones. Globally, there are many studies on the treatment of periodontitis with regeneration of periodontal tissue with very high results from enamel derivatives - Emdogain, opening a new direction for treatment of periodontitis. However, in Vietnam, there are still no research works on this issue, so we conduct research on the topic: “Clinical Outcome After Surgical Treatment Of Chronic Periodotal With Enamel Matrix Derivatives- Emdogain”. With the following goals: 1. Comment on clinical, X-ray of stage IV chronic periodontitis according to AAP of a group of patients at Hanoi Central Odontostomatology Hospital from 2016-2019. 2. Evaluation of surgical treatment results for chronic periodontitis using enamel matrix derivatives - Emdogain on the control group of patients.
2 URGENCY OF THE TOPIC Periodontitis is a common disease especially in Vietnam, according to the 2001 National Oral Health Survey, the rate of people with gingivitis and periodontitis up to 90%. Inflammation around the teeth causes bone resorption, loss of gums, moving teeth leading to tooth loss. There are a variety of therapeutic, surgical and non-surgical treatments for periodontitis, with the goal of preventing the destruction of the periodontal tissue and in some cases, attempting to regenerate the periodontal tissue. Emdogain is a gel protein that helps preserve periodontal tissue by promoting the regeneration of soft and hard tissues of the tooth organization destroyed by inflammation around the tooth. Lots of clinical studies have proven safe and effective results in forming new periodontal tissue. In Vietnam, there are many studies on renewable materials, but there are no studies on the application of Emdogain, so the topic is urgent to help dentists with more options in the treatment periodontitis PRACTICAL MEANING AND NEW CONTRIBUTION Since the early twentieth century, many surgical methods have been introduced to treat periodontitis and bring about encouraging results. However, these methods are still limited in the regeneration of periodontal tissue. Many grafting materials in periodontal surgeries are studied in the second half of the XX century have yielded superior results in tissue regeneration compared to simple flap surgery. Emdogain stimulates production of collagen, cement cells and alveolar bone cells on the root surface. Emdogain has been researched and used in developed countries, but in Vietnam, there has been no research application of this product in the treatment periodontitis. So this study has high practical significance and has made a new contribution to the treatment periodontitis in Vietnam. THESIS STRUCTURE The thesis includes 122 pages, Background (2 pages), Overview (39 pages), Subjects and methods (20 pages), results (32 pages), discussion (27 pages), conclusion (1 pages) and recommendation (1 page). The whole thesis includes 38 tables, 15 figures, 6 charts. The number of references are 87 (15 Vietnamese and 72 English)
3 B. CONTENT Part I: BACKGROUND 1.1 Anatomical physiological of periodontal tissue 1.1.1. Gums: is the differentiated mucosa that embraces the neck, a part of the root and the alveolar bone. 1.1.2. Periodontal ligament: A special connective tissue connecting the alveolar bone with cement, the thickness changes depending on the age and the chewing force, usually 0.15 - 0.35mm thick. 1.1.3. Cement: An inorganic organization covering the dentin, of mesenchymal origin, the chemical composition of which is almost like bone, but without direct blood vessels and nerves. 1.1.4. Alveolar bone: is the concave part of the jaw bone that embraces the root and serves as the most important support tissue of the tooth. 1.2. Causes, mechanisms and classification of periodontal disease 1.2.1.Causes, mechanisms of periodontal disease: Although this problem is not fully understood, it has been established that periodontitis is an opportunistic infection with the primary cause of bacteria in dental plaque. 1.2.1.1. Role of bacteria and bacterial plaque: Tooth plaque is a biofilm containing bacteria. 1.2.1.2. Role of the immune response in periodontitis 1.2.2. Classification of periodontitis: the American Academy of Periodontitis classification is used more because it is simple but complete and very useful in clinical practice. 1.3. Indicators and criteria for assessment of status of periodontitis 1.3.1. Gum index 1.3.2. Simple oral hygiene index 1.3.3. Periodontal pocket: Normally the gum slot has a depth of less than 3mm. When the depth of the gums is over 3mm, there is a periodontal pocket 1.3.4. Loss of periodontal adhesion: When periodontitis, epithelial adhesion and ligaments around the tooth degenerate, the necrosis creates the distance from the path connecting the enamel to the bottom of the periodontal pocket. This is the area of loss of adhesion around the teeth. 1.3.5. Teeth move 1.3.6. Alveolar bone resorption: The alveolar bone on the side, between the two pointed teeth is called the alveolar crest with a thickness of 0.5- 1mm. The osteoblast below the enamel-cement seam is about 1-2mm, on the wide interstitial side this protrusion is thicker.
4 1.4. Treatment of periodontal disease 1.4.1. Conservative treatment: initial treatment and maintenance treatment 1.4.2. Surgical treatment: When the periodontal pocket has a depth of more than 5mm, conservative treatments have no results, so flap surgery is one of the most commonly used techniques to treat the periodontal pocket. - There are 3 techniques of flap surgery commonly used today are: + Widman flap modified. + Repositioned flap + The flap is put back to the root position. 1.5. Materials In Periodontal Regeneration 1.5.1. Membrane: Collagen membrane, Alloderm membrane (Acellular dermal matrix ADM) 1.5.2. Bones: Based on the origin of bones, it can be divided into four categories, including: autologous transplant, congener transplant, heterologous transplant and synthetic materials. 1.5.3. Growth factors: Plasma, platelet-rich Fibrin; Platelet-rich plasma; Fibrin is rich in platelets 1.5.4. Stem cells 1.6. The research treatment of periodontal surgery 1.6.1. In the world: According to research by Mitani, Takasu et al. 2014 in Japan, data from 40 subjects (44 teeth), with no history of smoking or systemic diseases that could interfere with periodontal disease and who received one of three surgical procedures (EMD, GTR or OFD) for two- or three-wall intrabony defects, were analyzed. Postoperative reduction in probing pocket depth, gain in clinical attachment level, gingival recession and percentage bone fill were compared at 1, 3 and 5 years. Reduction in probing pocket depth after GTR was significantly higher than after OFD at 1 and 3 years postoperatively, but there was no difference between the groups at 5 years. The gains in clinical attachment level for EMD (at 3 and 5 years) and for GTR (at 1, 3 and 5 years) were significantly greater than for OFD. According to Asta, Miliauskaite et al in 2008 in Germany studied on 60 alveolar bone defects in 25 patients assessed after surgery with EMD and papillary conservation surgery (PPT). Clinical parameters including clinical adhesion (CAL), perioral pocket depth probe (PD), and receding gums (GR) were evaluated at baseline for three years. As a result, positions treated with EMD demonstrated mean CAL range from 6.6 ± 1.2 mm to 3.4 ± 1.3 mm (p
5
6 n: sample size for each group ES: size of impact µ1 is the mean of the control group. Select µ1 = 2.24 (depth of periodontal pocket in the non-intervention group in the study of Stuart J. Froum with σ: standard deviation of the control group is 2.62). µ2 is the mean of the intervention group. Select µ1 = 3.5 (the depth of the periodontal pocket in the intervention group hope to achieve after the intervention in this study) Z1-α / 2 is the value from the normal distribution, calculated on the basis of the type I error. Choosing the 5% type I error probability with the 2-sided test, we have Z1-α / 2 = 1.96 Z1-β is the value calculated on the statistical force, choose the minimum statistical force of 80%, we have Z1-β = 0.842 Instead of the formula we get n = 68 * Sampling: Using intentional non-probability sampling method: based on selection and exclusion criteria, examine patients one by one, and stop until the required sample size is reached. In fact, we examined and performed an Emdogain flap surgical intervention on 73 teeth of 43 patients, ensuring that each patient had at least one tooth that received Emdogain transplant intervention. In a total of 43 patients with intervention teeth, we conducted a simple flap surgical treatment for 120 teeth with periodontitis, these teeth were included as the control group. The process of selecting teeth for surgery and performing primary surgery is known only to the research team. An examination is then carried out by a group of other doctors to record monitoring parameters of all teeth being treated without knowing exactly which teeth were undergo the initial intervention. 2.2.2. Means of study: periodontal probe, periodontal surgery kit, Emdogain®, EDTA 24%, Gracy curettage set. 2.2.3. Research Steps: Step 1: Record clinical symptoms and information. Step 2: X-ray film after the tooth drive, panorama film. Step 3: initial treatment. Step 4: Examination and re-evaluation of clinical indicators (after 3-4 weeks). Compared with the time before the initial treatment, if the inflammation ends but the measured periodontal pocket is still over 5mm, the treatment will be continued with simple flap surgery. At this time, we selected patients with relatively similar clinical symptoms and position, divided into 2 groups, group 1 with flap surgery
7 with support for periodontal tissue regeneration with Emdogain and group 2 with simple flap surgery without Emdogain. We then compared the results of the two groups. Step 5: Surgical process: Using modified Widman flap to modify the damaged root area, root surfaces are cleaned. Use 24% EDTA "gel" to remove the mulch for two minutes then rinse. - Place the EMD starting at the part closest to the tip and gradually moving towards the neck. - Closing the treatment area - stitching - Post-operative follow-up - maintenance: Re-examination after 4 weeks and after 8 weeks. Maintenance therapy begins follow-up every 3 to 4 months for 1 year. Step 6: Post-treatment assessment. Evaluate clinical results by exploration starting from month 2 and with long-tapered X-rays and panorama starting from month 8 determine: Plaque index (PI), Gingival index (GI), probe bleeding (BOP), periodontal pocket depth (PD) mm, receding gums (GR) mm, clinical adhesion level (CAL) mm, alveolar bone resorption (mm). *Evaluate the results after 4 weeks of treatment: - Good level: gums are free of inflammation, pink, firm, do not bleed on examination, clean teeth without dental plaque; Gingival index from 0-0.1; Plaque index from 0-0.1 - Moderate level: slightly inflamed gums, pale pink color, bleeding on examination, with very little dental plaque; Gingival index from 0.1- 0.9; Plaque index from 0.1-0.9 Poor level: Inflammatory gum condition not improved; Gingival index> 1; Plaque index> 1 * Criteria to evaluate results after 8 months of treatment - Good level: Gingival index (GI) from 0-0.1; plaque index from 0- 0.1; Periodontal pocket less than 3mm; Increased clinical adhesion, alveolar bone by over 65% - Moderate level: Gingival index (GI) from 0.1-0.9; plaque index from 0.1-0.9; Periodontal pocket reduced but still 3-5mm deep; Increased clinical adhesion, alveolar bone between 40-65% - Poor level: Gingival index (GI) from 0.1-0.9; plaque index from 0.1-0.9; Periodontal pocket reduced but still 3-5mm deep; Increased clinical adhesion, alveolar bone less than 40% * To avoid errors: 1) The doctor evaluates the patients at two separate times: present and after 48 hours. Results are accepted if
8 measurements at two points correspond to up to 90%. 2) The evaluator is trained to perform clinical measurements after treatment and is not informed which surgical procedures have been performed. 2.2.4. Data processing: Data is verified for distribution before using the appropriate statistical test. The quantitative variables were averaged, the two averages were compared using the student t test. Qualitative variables were percentages, compared ratios using the test 2, and Fisher's accuracy test. - The data were entered in Excel, then cleaned and analyzed using SPSS 20.0 software. 2.3. Ethical issues: Ensure the research follow the Ministry’s regulations on code of ethics in medical. The research was approved by the Ethics Council of Hanoi Medical University on February 20, 2016 No. 187 / HDĐĐHYHN. Part III: RESEARCH RESULTS 3.1. GENERAL CHARACTERISTICS OF STUDIED SUBJECTS 3.1.1. Age and gender characteristics Table 3.1. Distribution of study subjects by age and sex Number % Mean age ±SD Male 24 55.8 40.4 ± 8.5 Female 19 44.2 39.9 ± 12.3 Total 43 100.0 40.2 ± 10.2 Comments: The subjects of the study are from 20 to 65 years old, mainly focus at the age of 32 - 48, the average is 40.4 ± 8.5 years old. Out of 43 participants, there are 24 men, accounted for 55.8% and 19 women, accounted for 44.2% of the total participants. 3.1.2. Reasons for examination of research subjects Table 3.2. The reason for the examination Reason Number % Bleeding gums 14 32.6 Toothache 15 34.9 Wobbly teeth 7 16.3 Periodic examination 3 6.9 Other 4 9.3 Total 43 100 Comments: Among 43 study subjects, 15 people came to the examination because toothache accounted for 34.9%, 14 people came to the examination because gingival bleeding accounted for 32.6%, 7
9 people came to the examination with The reason that teeth moved accounted for 16.3%, and 3 people for periodical examination accounted for 7%. 3.1.3. Period of periodontal disease of studied subjects Table 3.3. Distribution of periodontal disease Years Number % < 1 year 15 34.9 1 – 5 years 22 51.2 > 5 years 6 13.9 Total 43 100 Comment: Regarding to the period of periodontal disease of the participants, there are 22 patients having period of disease from 1-5 years, accounted for 51.2%, 15 patients having period of periodontal disease under 1 year accounted for 34.9%, and only 6 patients with the duration of the disease more than 5 years, accounted for 14%. 3.1.4. Distribution of damaged teeth Table 3.4. Distribution of damaged teeth The Incisors Molars Premolars tooth Total area p Group n % n % n % disease Intervention 8 10.96 18 24.66 47 64.38 73 group Control 0.02 31 25.83 32 26.67 57 47.50 120 group Total 39 20.21 50 25.91 104 53.7 193 Comments: The molar injury is the most abundant, accounted for 64.38% in the intervention group. In the control group, the molars of the molars accounted for 47.5%. Small molar injuries in the intervention group accounted for 24.66%, and in the control group accounted for 26.67%. The incisional injury accounted for the lowest rate in the intervention group, about 10.96%, and in the control group accounted for 25.83%. There is a statistically significant difference in the damage rates to different tooth areas (with p
10 3.2. CHARACTERISTICS OF CLINICAL AND X-RAY OF THE PERIODONTAL DISEASE BEFORE TREATMENT Table 3.5. Average periodontal pocket depth, clinical adhesion, receding gums Intervention group Control group Number Mean Number Mean p* of teeth value of teeth value (n) ( X ±SD) (n) ( X ±SD) Periodontal
11 Comments: Of the 73 intervention teeth, there were 70 teeth moving level 2, accounted for 95.9%, only 3 teeth were moving at level 3, accounted for 4.1%. In 120 control teeth, there were 117 teeth moving level 2, accounted for 97.5%, only 3 teeth moving at level 3, accounted for 2.5%. Intervention Control Gingival bleeding on group group p examination (n,%) (n,%) Percentage of bleeding at 72 (98.6%) 117 (97.5%) examination Percentage of sites that did 1.0 1 (1.4%) 3 (2.5%) not bleed at examination Total 73 (100%) 120 (100%) *: Fisher Exact’s test Table 3.6 Gingival bleeding on examination Comment: All the teeth in the intervention group or the control group are suffering from severe periodontitis, the bleeding position during examination accounted for 98.6% in the intervention group, while the control group accounted for 97. 5%. The position of no bleeding at examination of the intervention group was only 1.4%, the control group accounted for 2.5%. There was no statistically significant difference in the number of teeth bleeding on examination (p> 0.05). Table 3.7. The level of alveolar bone resorption Intervention group Control group Number Mean Number Mean p of teeth value of teeth value (n) ( X ±SD) (n) ( X ±SD Mức tiêu
12 *) Fisher Exact’s test Chart 3.2. Inflammation of the gums Comment: All patients with periodontitis in the intervention and control groups had mild and moderate gingivitis according to the criterias of Löe and Silness (1967). There were 50.7% of patients with mild period perioditis in the intervention group (with indexes from 0.1 to 0.9), while in the control group, this rate was 45.0%. The rate of periodontitis patients in the intervention group with average gum status (from 1.0 to 1.9) accounted for 45.2%, this rate in the control group was 52.5%. Severe gingivitis of the intervention group accounted for 4.1%, this rate of the control group was 2.5%. There was no statistically significant difference in the pre-treatment gum index between the control group and the intervention group (p> 0.05). Table 3.8. Plaque accumulation Intervention Group Control group Plaque Index p Number % Number % 0.1 – 0.9 23 31.5 53 44.2 1.0 – 1.9 48 65.8 60 50.0 0.09 2.0 – 3.0 2 2.7 7 5.8 Total 73 100 120 100 *: Fisher Exact’s test Comment: All patients with periodontitis in both groups had moderate plaque accumulation according to the plaque index of Löe and Silness (1967). 65.8% of the periodontitis patients in the intervention group had average plaque accumulation while this rate in the control group was 50.0%. The rate of dental plaque accumulation at a mild level
13 (from 0.1 to 0.9) in the intervention group was 31.5% and in the control group was 44.2%. The rate of dental plaque accumulation at a severe level (from 2.0 to 3.0) in the intervention group was 2.7% and in the control group was 5.8%. There was no statistically significant difference in the plaque index between the intervention group and the control group (p> 0.05). 3.3.5. Comparison of treatment results between two surgery groups 3.3.5.1 Compare the results of reduction of periodontal pocket depth Comparison of postoperative treatment outcomes of the intervention group and control group including changes in clinical characteristics and radiology Table 3.9. Compare the results of reduction of periodontal pocket depth between the two groups Intervention Group Control group Reduction Reduction Time Probing of probing Probing of probing pocket pocket pocket pocket p depth mm depth depth mm depth mm mm ( X ±SD) ( X ±SD) ( X ±SD) ( X ±SD) Before treatment 7.30±1.48 - 6.37±1.49 -
14 pocket depth after 12 months of treatment in both groups of patients decreased compared to that before treatment. After intervention treatment, the decrease in the depth of periodontal pocket in the surgical group increased statistically significant compared with the decrease in the depth of the bag around the teeth in the control group, with p
15 3.3.5.3. Compare receding gums Table 3.11. Compare receding gums results between the two groups Intervention group Control group Time Increase Increase Gingival Gingival gingival gingival p recessionm recession recession recession m mm mm mm ( X ±SD) ( X ±SD) ( X ±SD) ( X ±SD) Before treatment 0.75±0.94 - 0.81±1.07 - 0.712 (1) After 2 months of treatment 1.46±1.11 0.74±0.88 1.16±1.23 0.37±1.08 0.082 (2) After 8 months of treatment 1.48±1.10 0.76±1.01 1.29±1.25 0.51±1.39 0.274 (3) After 12 months of treatment 1.61±1.10 0.89±1.23 1.29±1.24 0.51±1.67 0.067 (4) Comment: After 2 months of treatment, the intervention group increased gum receding was 0.74 ± 0.88mm, the control group increased gum receding was 0.37 ± 1.08mm. This difference is not statistically significant with p> 0.05. After 8 months of treatment, the intervention group increased gum receding was 0.76 ± 1.01mm, the control group increased gum receding was 0.51 ± 1.39mm. This difference is statistically significant with p 0.05
16 3.3.5.4. Compare alveolar bone resorption Table 3.12. Compare the results of alveolar bone fill between two groups Intervention Group Control group Alveolar Alveolar Time Alveolar Alveolar bone bone bone fill bone fill resorption resorption p1&2 mm mm mm mm ( X ±SD) ( X ±SD) ( X ±SD) ( X ±SD) Before treatment 84.0±1.05 - 7.88±1.08 - (1) After 8 -12 months 5.97±0.75 2.42±0.58 5.71±0.87 2.17±1.15 0.16 (2) p*
17 3.3.5.5. Comparison of treatment effects between the two groups Table 3.13. Comparison of treatment effects between the two groups Intervention group Control group ( n, %) ( n, %) p Averag Criteria Good Average Poor Good Poor e Decrease d