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临床试验/NCT07386925
NCT07386925尚未招募不适用

Clinical and Radiographic Evaluation of Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth

Tanta University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
absence of pain

研究概览

简要总结

The success of pulpotomy in primary teeth is critical for preserving function and arch integrity in children and depends largely on the biological properties of the medicament used. Given the limitations of mineral trioxide aggregate, Pelargonium graveolens essential oil has emerged as a potential alternative; however, its clinical performance as a pulpotomy agent remains insufficiently investigated.

详细描述

The use of medicinal plants and herbal extracts in modern dentistry is steadily increasing, primarily due to their antimicrobial properties and high biocompatibility. Pelargonium graveolens (rose geranium), native to South Africa, produces an essential oil rich in geraniol, citronellol, and linalool[18]. Geraniol, present in rose geranium oil, is recognized for its antioxidant, anti-inflammatory, antimicrobial, and anticancer effects. The oil's main constituents, beta-citronellol and geraniol, contribute to its antifungal and wound-healing properties, making it a promising agent for treating denture-induced stomatitis

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Restorable primary molars with deep carious lesions.
  • Absence of gingival swelling or sinus tract.
  • Absence of spontaneous pain
  • Absence of pain on percussion.
  • Absence of discontinuity of lamina dura
  • Absence of internal root resorption.
  • Absence of external root resorption.
  • Absence of inter-radicular or periapical bone destruction (radiolucency).

排除标准

  • presence of spontaneous pain
  • presence of gingival swelling or sinus tract
  • presence of internal or external root resorption
  • pain on percussion.

研究组 & 干预措施

group 1: zinc oxide-geranium (Pelargonium graveolens) essential oil paste

Experimental

30 primary molars will be treated with geranium (Pelargonium graveolens) essential oil freshly mixed with zinc oxide powder till it reaches a suitable consistency (1:1 ratio by volume) to cover pulp stumps

干预措施: Radiation (Procedure)

group 1: zinc oxide-geranium (Pelargonium graveolens) essential oil paste

Experimental

30 primary molars will be treated with geranium (Pelargonium graveolens) essential oil freshly mixed with zinc oxide powder till it reaches a suitable consistency (1:1 ratio by volume) to cover pulp stumps

干预措施: pulpotomy (Procedure)

group 2: MTA

Active Comparator

30 primary molars will be treated with MTA to cover pulp stumps

干预措施: pulpotomy (Procedure)

group 2: MTA

Active Comparator

30 primary molars will be treated with MTA to cover pulp stumps

干预措施: Radiation (Procedure)

结局指标

主要结局

absence of pain

时间窗: up to 9 months

Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain

absence of fistula

时间窗: up to 9 months

Measuring Method: Visual examination by operator Measuring Unit: score 0 for absence of swelling and score 1 for presence of swelling

Tenderness to percussion

时间窗: up to 9 months

Measuring Method: Percussion test Measuring Unite: Binary (+/-)

Furcation radiolucency

时间窗: 3 months

Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value)

furcation radiolucency

时间窗: 6 months

Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value)

furcation radiolucency

时间窗: 9 months

Description: Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Shaban Mohamed El-desouky

assistant professor of pediatric dentistry

Tanta University

研究点 (1)

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