Efficacy Evaluation of Combination Therapy in Patients with Generalized Periodontitis According to the Index Estimation of Periodontal Status: Experimental Randomized Single-Arm Study

A. Romanenko, S. Sirak, Z. K. Shamanova, Yu. V. Verevkina, N. Bykova, V. N. Lenev, A. Arutyunov
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Abstract

Background. Treatment and prevention of inflammatory periodontal diseases represent a serious general medical and social problem, which remains relevant due to the significant prevalence of periodontitis among the population, as well as the associated loss of teeth and the negative impact of periodontal foci of infection on the body as a whole. Chronic generalized periodontitis is difficult to treat: it is only possible to achieve periods of remission. Therefore, it is of great theoretical and practical importance to develop further ways to improve methods for treating inflammatory-dystrophic damage of periodontal tissues in chronic generalized periodontitis.Objective. To perform an index estimation of treatment efficacy in patients with moderately severe chronic generalized periodontitis.Methods. An experimental randomized single-arm study was conducted examining 204 patients diagnosed with moderately severe chronic generalized periodontitis. Patient examination and data analysis were carried out at the Dentistry Department of the Stavropol State Medical University and the Department for General Practice Dentistry of the Kuban State Medical University in 2021–2022. The study included patients aged 35 to 65 years diagnosed with moderately severe chronic generalized periodontitis. Patients with somatic diseases in the decompensation stage were not eligible for the study. The patients were randomly divided into three groups (closed-envelope method). Group 1 was treated using conventional methods. As well as conventional therapy, Group 2 was prescribed vitamin D (Aquadetrim® at a dose of 5000 IU once per day while monitoring vitamin D blood level). The third group of patients was prescribed conventional therapy along with the developed pharmacotherapy, which included vitamin D (Aquadetrim® at a dose of 5000 IU once per day), vitamin A (3.44% oil solution of retinol acetate at a dose of 50 000 IU, 15 min after a morning meal), and 2-ethyl-6-methyl-3-hydroxypyridine (Mexidol® at a dose of 125 mg twice a day). In each patient, the treatment efficacy was analyzed in adjacent oral cavity segments (split-mouth design) according to clinical pocket depth, attachment loss, and bleeding on probing. Also, the authors used the X-ray index to assess the condition of osseous structures and the simplified oral hygiene index. The specified indices were estimated prior to treatment and at one and 12 months following treatment. The statistical analysis of study results was performed using Excel Microsoft Office 2016 (Microsoft, USA).Results. The obtained data indicate that the immediate clinical outcomes (after one month) of combination therapy in patients from all three groups were approximately the same. However, the efficacy of treatment measures in the long-term period (12 months) was different, as evidenced by the dynamics of index values. Only in Group 3 patients, the full implementation of pharmacotherapeutic measures as part of the combination therapy of periodontitis ensured a stable therapeutic effect throughout the entire period of observation.Conclusion. The data obtained 12 months following treatment indicate that the additional prescription of the developed pharmacotherapy contributed to prompt inflammation relief in periodontal tissues, providing a stable treatment outcome and long-term remission.
根据牙周状态指数评价综合治疗对广泛性牙周炎的疗效:实验性随机单组研究
背景。炎症性牙周病的治疗和预防是一个严重的普遍医学和社会问题,由于牙周炎在人口中非常普遍,以及相关的牙齿脱落和牙周病灶感染对整个身体的负面影响,这一问题仍然具有相关性。慢性广泛性牙周炎很难治疗:它只能达到缓解期。因此,进一步完善治疗慢性广泛性牙周炎牙周组织炎症-营养不良损伤的方法具有重要的理论和现实意义。目的:对中重度慢性广泛性牙周炎患者的治疗效果进行指数评价。对204例诊断为中重度慢性广泛性牙周炎的患者进行了一项随机单臂实验研究。2021-2022年期间,在斯塔夫罗波尔国立医科大学牙科系和库班国立医科大学普通牙科系对患者进行了检查和数据分析。该研究包括35至65岁诊断为中重度慢性广泛性牙周炎的患者。处于失代偿阶段的躯体疾病患者不符合研究条件。患者随机分为三组(封闭包络法)。第一组采用常规治疗方法。在常规治疗的基础上,第二组给予维生素D (Aquadetrim®,每天一次,剂量为5000 IU,同时监测血液中维生素D的水平)。第三组患者在常规治疗的同时进行药物治疗,包括维生素D (Aquadetrim®,剂量为5000 IU,每天1次)、维生素a(3.44%视黄醇醋酸酯油溶液,剂量为50000 IU,早餐后15分钟)和2-乙基-6-甲基-3-羟吡啶(Mexidol®,剂量为125 mg,每天2次)。每位患者根据临床牙袋深度、附着缺失、探诊出血情况,对相邻口腔段(裂口设计)进行治疗效果分析。并采用x线指数评价骨组织状况和简化口腔卫生指数。在治疗前和治疗后1个月和12个月对指定指标进行评估。采用Excel Microsoft Office 2016 (Microsoft, USA)软件对研究结果进行统计分析。获得的数据表明,三组患者联合治疗的直接临床结果(一个月后)大致相同。然而,长期(12个月)治疗措施的疗效不同,这可以从指标值的动态变化中得到证明。只有第3组患者在牙周炎联合治疗中充分实施药物治疗措施,确保了整个观察期间治疗效果稳定。治疗12个月后获得的数据表明,开发的药物治疗的额外处方有助于迅速缓解牙周组织的炎症,提供稳定的治疗结果和长期缓解。
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