Assessment of Bone Mineral Density and Periodontal Status in Patients With Epilepsy on Mono- and Combination Therapy of Antiepileptic Drug: A Cross-sectional Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
Assessment of bone mineral density and periodontal parameters in patients with epilepsy. Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on monotherapy, combination therapy, and systemically healthy individuals.Comparative evaluation of periodontal parameters in all the patients who are on monotherapy and combination therapy and in systemically healthy individuals.
详细描述
Epilepsy is one of the most commonly encountered neurological conditions. Approximately one-third of the patients affected by this disease need to have life-long treatment with antiepileptic drugs(AEDs) . Various studies have shown that AEDs are major risk factors for bone diseases not only in institutionalized individuals and those having low Vitamin-D consumption, reduced sunlight exposure and diminished physical activity but also in non-institutionalized patients, well-nourished ambulatory adults, postmenopausal women, older men and children with this disease.The earliest reports regarding the negative effect of antiepileptic drugs on bone metabolism date back to the late 1960s. Various studies have been performed to explore the relationship between AEDs and bone metabolism but findings remain inconclusive.
AEDs are given as either monotherapy or polytherapy. In monotherapy, the antiepileptic drugs which are most commonly associated with altered bone metabolism include carbamazepine, phenytoin, primidone and phenobarbitone. New generation AEDs such as lamotrigine(LTG), topiramate, levetiracetam(LEV) are approved to be used as both antiepileptic monotherapy as well as adjuvants in combination with other AEDs. Some studies showed a negative influence of these new AEDs on bone health while other studies reported contradictory findings.
Biochemical indices are used for the measurement of blood concentration of calcium ,phosphorus, vitamin D, parathyroid hormone,bone remodelling markers like receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin(OPG). All these markers identify the patients with bone disease in an indirect way. Bone mineral density (BMD) tests have utility in detecting osteoporosis, assessing risk for bone fracture and also monitoring the response to osteoporosis therapy. Values of BMD test depend upon bone mineral content(BMC) and bone size. Dual-energy x-ray absorptiometry (DEXA) is a painless, non-invasive and easy to use technique for detection of bone mineral density (BMD) with the added benefit of low radiation exposure. It was earlier demonstrated that AEDs possess the property of enzyme induction activity through hepatic cytochrome P450 enzyme system, and this was held causative for metabolic bone diseases by increasing vitamin D metabolism, secondary type hypocalcemia and hyperparathyroidism. However, various studies have reported that both non-enzyme inducing and enzyme inducing AEDs have the potential to result in metabolic bone disease.
R.A. Seymour et al. (1985) conducted a study in which they investigated the periodontal health of adult patients with epilepsy matched in two groups and treated with either sodium valproate or phenytoin drug therapy. They reported that significantly less bone loss was observed in the phenytoin group than those on sodium valproate or the control patients. The limitation of this study was a small sample size and selection of anterior teeth only for recording periodontal parameters and alveolar bone loss.
The present study has been designed with the aim to compare bone mineral density, periodontal parameters and marginal alveolar bone levels in individuals who are on antiepileptic drugs - either sodium valproate or levetiracetam as monotherapy or on a combination regime of both the drugs(sodium valproate and levetiracetam) for at least 1 year with systemically healthy individuals. The present cross-sectional study will be conducted in the Department of periodontology, Post Graduate Institute of Dental Sciences, Rohtak in collaboration with Department of neurology, Post Graduate Institute of Medical Sciences, Rohtak.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals will be included in the study with the age range of 18-40 years. The selection of individuals will be according to age group, body mass index, and duration of drug therapy.
- •Control group individuals will be systemically healthy. Test group individuals will comprise of individuals diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) criteria,1981 and monitored by the Department of Neurology, Post Graduate Institute of Medical Sciences, Rohtak.
- •The duration of antiepileptic drugs should at least 1 year at the time of enrollment.
排除标准
- •Post-menopausal women The disease that affect bone health like Paget's disease, Multiple myelomas, osteoporosis.
- •Individuals who are already taking steroid therapy, Bisphosphonates therapy. Individuals on vitamins and calcium supplements. With a history of substance abuse (Tobacco/Alcohol) Malabsorption syndrome (Ulcerative colitis, Crohn's disease, Celiac disease, etc.)
结局指标
主要结局
Bone mineral density
时间窗: 1year
DUAL ENERGY X-RAY ABSORPTIOMETRY (DEXA)- There are two s.d. scores, T-scores and Z-scores. The T-scores compare the BMD values obtained with a sex-matched and race matched population at peak BMD, while the Z-scores compare the BMD measurements with an age-matched population. According to the WHO, patients with scores that are 1 - 2.5 s.d. below normal DEXA-values have osteopenia, while those with values \>2.5 s.d. below normal values are described as osteoporotic. When evaluating DEXA scans, 1 s.d. represents a T-score of 1. Thus, a patient with an s.d. of 3 below normal (i.e., osteoporosis) will have a T-score of -3.
Marginal alveolar bone levels
时间窗: 1 year
By using RVG with the help of XCP-film holder, levels of marginal bone will be measured from Cemento-enamel junction to crest of alveolar bone on mesial and distal aspect of index teeth (first molar of each quadrant and central and lateral incisors of 2nd and 4th quadrant) Index teeth for scoring will be 1st molar from each quadrant and central and lateral incisor of 2nd and 4th quadrant. If index teeth are missing then we will take adjacent teeth as index teeth in our study.
次要结局
- Gingival Index (GI)(1year)
- Pocket Probing Depth (PPD)(1year)
- Plaque Index (PI)(1year)
- Bleeding On Probing (BOP)(1year)
- Clinical Attachment Loss (CAL)(1year)
