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临床试验/CTRI/2013/01/003286
CTRI/2013/01/003286已完成不适用

CLINICAL AND RADIOGRAPHIC ASSESSMENT OF BONE REGENERATION USING ALENDRONATE SODIUM GEL AS ANADJUNCT TO SURGICAL THERAPY FOR THE TREATMENT OF OSSEOUS DEFECTS IN CHRONIC PERIODONTITIS- A COMPARATIVE STUDY

PRINCIPAL INVESTIGATOR1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年12月7日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
•To assess the bone regeneration in osseous defects clinically

研究概览

简要总结

Periodontitis is one of the major causes of tooth loss in the world. It encompasses multifactorial diseases involving bacterial biofilms and generation of an inflammatory response including the production of cytokines and matrix metalloproteinases.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

For many years, the major focus of periodontal research has been directed towards the reduction or elimination of pathogenic bacteria that are thought to cause periodontitis. This has been accomplished in a large part by the use of mechanical treatment approaches like scaling and root planning, use of home care measures and finally surgical intervention. In recent years, other adjunctive approaches that aim to eradicate or reduce the periodontal disease initiation or progression have included pharmacologic measures with the use of systemic and/or local anti-microbial therapies.

Even when periodontal diseases are controlled or cured, the patients are often left with an anatomical evidence of the disease, including loss of bone and periodontal support for their remaining teeth. Therefore, newer approaches are being developed to stimulate regeneration of lost periodontal tissues.

Apart from periodontal therapy directed towards regeneration, it appears that most treatments available today are directed towards reduction or elimination of exogenous factors that might cause or exacerbate periodontal diseases. There is still an increasing body of evidence suggesting that various approaches which involve host modulation might also be helpful in the management of periodontitis and its sequelae.

Three potential approaches to host modulation therapy have been considered: 1) inhibition of matrix metalloproteinases with antiproteinases,e.g. tetracyclines. 2) blocking production of pro-inflammatory cytokines and prostaglandins with anti-inflammatory drugs, e.g. NSAIDs: aspirin, ibuprofen, naproxen.  and 3) inhibiting activation of osteoclasts with bone sparing agents e.g. bisphosphonates: Alendronate.

The bisphosphonates are synthetic biochemical modifiers of bone resorption. The bisphosphonates are widely used in the management of systemic metabolic bone diseases due to their ability to inhibit bone resorption. Given their known affinity to bone, ability to increase osteoblastic differentiation and to inhibit osteoclast recruitment and activity; there exists a possible use for bisphosphonates in the diagnostic and management of periodontal diseases.

Among Bisphosphonates, Alendronate Sodium has been found to be very effective in inhibition of bone resorption.  When given systemically in patients with periodontal disease, Alendronate can significantly reduce alveolar bone resorption and cause an improvement in the height of the crestal bone.

Though the systemic use of bisphosphonates, including etidronate, alendronate, pamidronate and risedronate, can lead to reduced bone turnover, increased bone mass and improved mineralization, studies have shown similar promising results with the local use of bisphosphonates.

Studies have shown that systemically administered bisphosphonates can induce gastrointestinal disturbances such as esophagitis, erosions, and ulcerations. Local drug application avoids most of these problems, by limiting the drug to the target site (site specific approach) with little or no systemic uptake. Also, the local concentration achieved can be much higher (100 folds) than that via systemic route.

Thus, the present study aims to evaluate clinically and radiographically the efficacy of local application of 1% Alendronate Sodium gel as anadjunct to surgical therapy in the treatment of osseous bone defects in patients with chronic periodontitis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
35.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • a)Patient of either sex within the age group of 35-50 years.
  • b)Systemically healthy patients.
  • c)Clinical diagnosis of moderate generalized chronic periodontitis.
  • d)Patients with probing depth ≥5 mm or clinical attachment loss > 4 to 6 mm bilaterally as evidenced by clinical examination.
  • e)Patients with vertical bone loss > 5mm as evidenced on IOPA radiograph.
  • f)Patients with acceptable oral hygiene following Phase-I therapy.

排除标准

  • a)Patients with presence of systemic conditions or disease affecting bone density e.g. Osteoporosis, Paget’s disease.
  • b)Patients with known or suspected allergy to Alendronate/ bisphosphonates group.
  • c)Patients with Aggressive Periodontitis.
  • d)Patients with horizontal bone loss.
  • e)Patients without any contradictions for periodontal surgery.
  • f)Patients with a history of drug intake that can affect bone metabolism in the past 6 months.
  • E.g. NSAIDs. g)Patients who are current smokers, or ex smokers for less than five years.
  • h)Pregnant or lactating females.
  • i)Patients who are alcoholics.
  • j)Immunocompromised patients.
  • m)Patients who have taken medications affecting periodontal status or has received periodontal therapy in the preceding six months.

结局指标

主要结局

•To assess the bone regeneration in osseous defects clinically

时间窗: Recall Appointments at 1 month, 3 month, 6 month & 9 month post surgery intervals for post operative review and clinical and radiological assessment.

•To assess the bone regeneration in osseous defects radiographically

时间窗: Recall Appointments at 1 month, 3 month, 6 month & 9 month post surgery intervals for post operative review and clinical and radiological assessment.

次要结局

  • Baseline clinical parameters like Bleeding on Probing, Gingival Index, Periodontal Probing Depth and Clinical Attachment Level of all the patients will be measured followed by radiographic assessment by intra-oral radiograph.(Recall Appointments at 1 month, 3 month, 6 month & 9 month post surgery intervals for post operative review and clinical and radiological assessment.)

研究者

申办方类型
Government medical college

研究点 (1)

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