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CTRI Number  CTRI/2025/07/092085 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of zinc oxide peppermint oil versus zinc oxide eugenol as obturating material of primary teeth: An in vivo study 
Scientific Title of Study   Comparative evaluation of zinc oxide peppermint oil versus zinc oxide eugenol as obturating material of primary teeth: An in vivo study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Muthusri B 
Designation  Post Graduate 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Department of pediatric and preventive dentistry, Room no: 6, Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308

Salem
TAMIL NADU
636308
India 
Phone  08344545722  
Fax    
Email  muthusri.b@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veena Arali 
Designation  Professor and HOD 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Department of pediatric and preventive dentistry, Room no 6, Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308

Salem
TAMIL NADU
636308
India 
Phone  9894810759  
Fax    
Email  aparnavvarthan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Muthusri B 
Designation  Post Graduate 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Department of pediatric and preventive dentistry, Room no 6, Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308

Salem
TAMIL NADU
636308
India 
Phone  08344545722  
Fax    
Email  muthusri.b@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Muthusri b 
Address  Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Muthusri B  Vinayaka Missions Sankarachariyar Dental College  Department of pediatric and preventive dentistry, Room no 6, Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308
Salem
TAMIL NADU 
08344545722

muthusri.b@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee of VMS Dental College Salem  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  dental treatment 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Zinc oxide Eugenol  zinc oxide eugenol as obturating material 4 scoops of zinc oxide powder with 10 drops of eugenol and will be used as obturating material one time in primary molar.  
Intervention  zinc oxide peppermint  zinc oxide peppermint oil as obturating material 4 scoops of zinc oxide powder with 28 drops of eugenol and will be used as obturating material one time in primary molar. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Identify the most efficient obturating materiaLs in primary teeth  Identify the most efficient obturating materiaLs in primary teeth.Baseline, 3 months and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 3 and 6 months intervals through a clinical examination according to Zurn and Seale pain rating scale.

Radiographic Assessment:

         The evaluations will be performed at baseline, 3 and 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.

 

 

 

 
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