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临床试验/CTRI/2025/07/092085
CTRI/2025/07/092085尚未招募4 期

Comparative evaluation of zinc oxide peppermint oil versus zinc oxide eugenol as obturating material of primary teeth: An in vivo study

Dr Muthusri b1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Identify the most efficient obturating materiaLs in primary teeth

研究概览

简要总结

Primary teeth play a vital role for the development of occlusion, maintenance of arch length, function of mastication and speech. It also acts as a natural space maintainer for permanent teeth. Hence pulp therapy is done to sustain the deciduous teeth in arch and to preserve the normal development of its succedaneous teeth.

Many obturating materials have been used for primary teeth root canals. These include zinc oxide eugenol, calcium hydroxide, iodoform pastes, vitapex, maistopaste, KRI paste and end of las. However, each of these materials has its own limitations.

Zinc oxide eugenol is widely used gold standard root canal filling material in the field of pediatric dentistry. However, it has its own disadvantages such as burning sensation on contact with soft tissues such as oral mucosa tongue etc. making the patient uncooperative during treatment, slow resorption as compared to normal physiologic root resorption of deciduous tooth. Due to its presence periapically, it may deflect the path of eruption of permanent successor.

 Ayurveda is the ancient Indian system of health care and longevity. The essential oils in the ayurveda have been proven to be safe and effective through several hundred years of use. One among them is peppermint oil.

Primary teeth play a vital role for the development of occlusion, maintenance of arch length, function of mastication and speech. It also acts as a natural space maintainer for permanent teeth. Hence pulp therapy is done to sustain the deciduous teeth in arch and to preserve the normal development of its succedaneous teeth.

Many obturating materials have been used for primary teeth root canals. These include zinc oxide eugenol, calcium hydroxide, iodoform pastes, vitapex, maistopaste, KRI paste and end of las. However, each of these materials has its own limitations.

Zinc oxide eugenol is widely used gold standard root canal filling material in the field of pediatric dentistry. However, it has its own disadvantages such as burning sensation on contact with soft tissues such as oral mucosa tongue etc. making the patient uncooperative during treatment, slow resorption as compared to normal physiologic root resorption of deciduous tooth. Due to its presence periapically, it may deflect the path of eruption of permanent successor.

Ayurveda is the ancient Indian system of health care and longevity. The essential oils in the ayurveda have been proven to be safe and effective through several hundred years of use. One among them is peppermint oil.

Peppermint oil is derived from the leaves of the peppermint plant. Menthol which is the main constituent of peppermint oil is used in toothpaste and mouthwashes as it has characteristic odor, taste followed by a sensation of cold.

In vitro studies have shown that peppermint oil exhibits antimicrobial property against E. faecalis which is found in the root canals.

There are no in vivo studies done using zinc oxide peppermint as obturating material. Therefore, in our study we consider evaluating zinc oxide peppermint success in primary teeth obturation in comparison with zinc oxide eugenol.

   Study design: Double -blind randomized controlled clinical trial. (participant and operator)

**Hypothesis:**There is no difference in the clinical and radiographic success rate of zinc oxide peppermint and zinc oxide eugenol as obturating material in primary teeth.

Ethics and informed consent:

Informed consent and assent will be taken from the parents and patients.

Period of study:

The time period for the study will be from June 2024 to June 2025

 Sample size: 42

 Study population:

The study population includes the children between the age group of 4-8 years reporting to the Department of Pediatric and Preventive dentistry, VMSDC Salem OPD.

Inclusion criteria:

Children aged 4-8 years.

Children with no history of systemic illness.

Teeth with caries, diagnosed as having irreversible pulpitis.

Teeth with two-thirds of root length intact.

Exclusion criteria:

Primary molars with preshedding mobility.

Children having systemic medical conditions.

Presence of external or internal resorption.

Presence of pulpal canal calcification.

Non restorable teeth with minimal crown height and difficulty in placing rubber dam.

An informed consent from the parent and children visiting the department of Paediatric and Preventive dentistry, VMSDC, Salem will be obtained for the intervention and the study participants will be randomly divided into 2 groups.

Randomization:

The randomization is achieved by simple randomization technique using lottery method.

Procedure:

Based on the inclusive and exclusive criteria a total of 42 children in the age group of 4-8 years will be selected for the study

Informed consents and assents will be obtained from the patients and parents.

Study participants will be divided into 2 groups. Blinding of the study participants will be done. The operator and the participants are blinded. Pre-op diagnostic radiographs with IOPA will be taken.Rubber dam will be placed to isolate the tooth. Local anesthesia will be used to obtain anesthesia.Cavity preparation will be done and pulp chambers will be opened under aseptic conditions with high-speed diamond burs. Fine-barbed broaches will be used to remove the coronal and radicular pulp. Copious saline irrigation will be performed to remove dentinal debris and pulp tissue remnants.Working length at 1–2 mm short of the apex on the radiograph will be set for all the canals. Pedoflex rotary files in sequential step back technique will be used for cleaning and shaping.Sterile paper points will be used to achieve dry canals.

In Group 1 Commercially available peppermint oil will be mixed with zinc oxide powder and will be obturated using lentulo spiral, the access cavity will be restored with GIC and stainless-steel crown will be cemented as a final restoration.

In Group 2 commercially available Eugenol will be mixed with zinc oxide powder and will be obturated using lentulo spiral, followed by restoration with glass ionomer cement and stainless-steel crown will be cemented as a final restoration.Immediate postoperative IOPA radiographs will be taken. The patient will be followed up clinically for evaluation of pain and radiographically for material resorption for 3and 6 months respectively.

Clinical Assessment:

The evaluations will be performed at baseline of 3and 6 months intervals through a clinical examination according to Zurn and Seale pain rating scale.

Radiographic Assessment:

The evaluations will be performed at baseline, 3and 6 month intervals through a radiological examination.

Radiographic success will be confirmed by the absence of any pathological root resorption, furcal radiolucency, internal/external resorption root resorption,resorption of material in canal.

研究设计

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

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children aged 4 to 8 years.
  • Children with no history of systemic illness.
  • Teeth with caries, diagnosed as having irreversible pulpitis.
  • Teeth with two-thirds of root length intact.

排除标准

  • Primary molars with preshedding mobility.
  • Children having systemic medical conditions.
  • Presence of pulpal canal calcification.
  • Non restorable teeth with minimal crown height and difficulty in placing rubber dam.

结局指标

主要结局

Identify the most efficient obturating materiaLs in primary teeth

时间窗: Identify the most efficient obturating materiaLs in primary teeth.Baseline, 3 months and 6 months

次要结局

未报告次要终点

研究者

发起方
Dr Muthusri b
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Muthusri B

Vinayaka Missions Sankarachariyar Dental College

研究点 (1)

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