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临床试验/CTRI/2024/09/074279
CTRI/2024/09/074279已完成4 期

Comparative evaluation of Calcium sodium phospho silicate dentifrice (CSPS) and Nano-hydroxy apatite dentifrice (NHA) in reducing Dentinal hypersensitivity after Scaling and Root planing.

Sibar institute of dental sciences1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年10月8日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
To assess and compare Schiff score and visual analog score in both groups.

研究概览

简要总结

Dentine hypersensitivity (DH) is characterized by short, sharp pain arising from exposed dentine in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be ascribed to any other dental defects or pathology. The diagnosis of this disease is often based on the subject’s self report of pain and requires exclusion of other dental and periodontal conditions that might cause pain. The successful treatment of periodontal disease depends on the effective removal of bacterial deposits from the tooth surfaces. This can be accomplished by thorough daily oral hygiene measures achieved by the patient and by professionally performed mechanical debridement. However, the establishment of healthy periodontal conditions by active treatment may often result in receding of the gingival tissues, leaving root surfaces exposed to the oral environment. The iatrogenic denudation of root dentin due to removal of the cementum layer is yet another complication to scaling procedures. The ultimate goal for treating DH is immediate relief with a long-lasting action. The efficacy of desensitizing agent’s that blocks the pain stimulus such as potassium or strontium-containing dentifrices is limited. Therefore, desensitizing agents that can occlude tubules and resist chemical substances and abrasion have been developed. Calcium sodium phosphosilicate, a bioactive glass, reacts when exposed to aqueous media and provides calcium and phosphate ions that form a hydroxyl carbonate, a mineral that is chemically similar to the mineral in enamel and dentin. The chemical reaction initiated by calcium sodium phosphosilicate to promote the formation of a hydroxyl carbonate layer for the treatment of DH is also useful in treating demineralized tooth structure or in preventing further demineralization. Synthetic carbonate hydroxyl-apatite nanocrystals have been shown to produce re-mineralization of the altered enamel surfaces and to be effective in closing dentinal tubules. The mechanism of action is based on occluding the dentinal tubules to block the hydrodynamic mechanism and pain stimulation by depositing a thin coating, or artificial smear layer, on the exposed dentin. Also, remineralizing the exposed dentin surface with deposits or precipitation of fine particles work to occlude the dentinal tubules. Patients will be receiving phase I therapy which includes scaling and root planing and thorough oral hygiene instructions will be given. Patients will be assessed for eligibility after 1 week. Parameters such as Schiff score; visual analog score will be measured at baseline. The dentifrice is applied to the teeth using a rubber cup with a low speed hand piece. Then two consecutive 3- second applications focusing on exposed cementum and dentine will be done. The clinical parameters were re-assessed immediately after the application. The participants were instructed about the home use of their dentifrice. Each participant will be given a new soft toothbrush and a tube of the assigned dentifrice. They will be informed to use only the toothbrush and dentifrice provided for the trial and instructed to not use a mouthwash while participating in this study. The home care instructions will be given, which comprises brushing twice daily using the modified bass technique with a 1-inch strip of the dentifrice for 2 minutes and rinsing one time with water. Patient will be recalled after 2 and 4 weeks parameters will be re-assessed. Follow up will be done at 2 weeks and 4 weeks for parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects who underwent scaling and root planing.
  • Subjects with Schiff score of 2-3 for atleast two teeth after scaling and root planing.
  • Subjects with VAS score of more than 4 for atleast two teeth after scaling and root planing.
  • Subjects willing to participate in the study.

排除标准

  • Subjects with dentinal hypersensitivity prior to scaling and root planing.
  • Subjects who are using agents to treat hypersensitivity in the past 3 months.
  • Subjects having pharmacotherapeutic histories that may compromise the protocol, including chronic use of anti-inflammatory, analgesic, or mind-altering drugs, and allergic to the test products (CSPS or NHA).
  • Dentin hypersensitivity caused by dental caries, defective restorations, fractured tooth, abrasion or abfraction, extensively restored teeth, orthodontic treatment within the past 3 months, crowded teeth, or abutment teeth for fixed or removable prosthesis.

结局指标

主要结局

To assess and compare Schiff score and visual analog score in both groups.

时间窗: baseline, after application, 2 weeks, 4 weeks

次要结局

  • schiff score, visual analog score.(Baseline, after application, 2 weeks, 4 weeks.)

研究者

发起方
Sibar institute of dental sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

GUMMADI TEJASREE

Sibar institute of dental sciences

研究点 (1)

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