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CTRI Number  CTRI/2025/09/095193 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treating teeth sensitivity with iontophoresis as a standalone treatment and along with commercially available toothpastes (Biomin and Perfora) 
Scientific Title of Study   Comparative evaluation of efficacy of iontophoresis in the treatment of dentinal hypersensitivity (DH) with iontophoresis as a standalone treatment and in combination with commercially available toothpastes (Biomin and perfora) in the management of Dentinal hypersensitivity at baseline and 3 months: Randomized clinical 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 Vimarsha R Achar 
Designation  Postgraduate 
Affiliation  Manipal College of Dental Sciences,Mangalore 
Address  Department of Periodontology 4th Floor Manipal College of Dental Sciences Mangalore Lighthouse Hill Road Hampankatta affiliated to Manipal Academy of Higher Education, Manipal
hampankatta
Dakshina Kannada
KARNATAKA
575001
India 
Phone  07022020172  
Fax    
Email  vimarsharamesh12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeetha U Nayak 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Department of Periodontology 4th Floor Manipal College of Dental Sciences Mangalore Lighthouse Hill Road Hampankatta affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  07022020172  
Fax    
Email  sangeeta.nayak@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sangeetha U Nayak 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Department of Periodontology 4th Floor Manipal College of Dental Sciences Mangalore Lighthouse Hill Road Hampankatta affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  07022020172  
Fax    
Email  sangeeta.nayak@manipal.edu  
 
Source of Monetary or Material Support  
Department of Periodontology 4th Floor Manipal College of Dental Sciences Mangalore Lighthouse Hill Road Hampankatta affiliated to Manipal Academy of Higher Education, Manipal, 575001, karnataka,India 
 
Primary Sponsor  
Name  Dr Vimarsha R Achar 
Address  Department of Periodontology 4th Floor Manipal College of Dental Sciences Mangalore Lighthouse Hill Road Hampankatta affiliated to Manipal Academy of Higher Education, Manipal 
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 Vimarsha R Achar  Manipal College of Dental Sciences, Mangalore  Department of Periodontology 4th Floor Manipal College of Dental Sciences Mangalore Lighthouse Hill Road Hampankatta affiliated to Manipal Academy of Higher Education, Manipal, 575001
Dakshina Kannada
KARNATAKA 
07022020172

vimarsharamesh12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Manipal College of Dental Sciences Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  systemically healthy patients 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator – Commercially available toothpastes (Biomin and Perfora) without iontophoresis  Participants in the comparator group will use either Biomin or Perfora toothpaste as per manufacturer instructions. The toothpaste will be applied by regular toothbrushing, twice daily, for the full 3-month study period. No iontophoresis will be performed in this group. 
Intervention  Iontophoresis (as a standalone treatment) and Iontophoresis in combination with commercially available toothpastes (Biomin and Perfora).  The intervention will be carried out using iontophoresis for the management of dentinal hypersensitivity. The procedure involves the application of a low-intensity electric current to facilitate the penetration of desensitizing agents. It will be administered in sessions at baseline and evaluated again at 3 months. In the combination groups, iontophoresis will be used along with Biomin or Perfora toothpaste, applied according to manufacturer instructions (twice daily brushing), throughout the 3-month study period. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients must have at least two sensitive permanent tooth surfaces on the buccal/facial aspects of incisors, canines, or premolars.

2.Patients should be systemically healthy.

3.Patients with wasting diseases and/or gingival recession will be included.

4.must provide signed informed consent.

5.Sensitive tooth surfaces should present with wasting diseases and/or gingival recession. 
 
ExclusionCriteria 
Details  1.Patients who have undergone active periodontal treatment within the last 6 months.

2.Pregnant or lactating females.

3.Patients with deleterious habits such as smoking and/or alcohol consumption.

4.Patients already undergoing treatment for dentinal hypersensitivity (DH).

5.Patients with a known allergy.

6.Patients with pacemakers.

7.Patients with sensitivity due to gastroesophageal reflux disease (GERD).

8.Patients with medical (including psychiatric and pharmacotherapeutic) histories that could compromise the study.

9.Patients with systemic conditions that are etiologic or predisposing to dentinal hypersensitivity, including eating disorders.

10.Patients who have received any dental treatment that might interfere with the action of the desensitizing agent being tested.

11.Patients presenting with any other oral pathology.

12.Individuals with orthodontic appliances or bridgework that could interfere with evaluation.

13.Dentinal hypersensitivity will be assessed by air blast stimulation; patients unable to undergo this assessment will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Verbal rating scale
Visual analogue scale
plaque index 
baseline
2 weeks
1 month
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
air blast test
tactile test 
baseline
2 weeks
1 month
3 months 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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   N/A 
Date of First Enrollment (India)   03/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Dentinal hypersensitivity (DH) is characterized by brief, sharp pain from exposed dentin due to external stimuli, not linked to other dental issues. It often affects the cervical areas of premolars and canines, causing discomfort that can hinder proper oral hygiene. DH is triggered by thermal, chemical, and mechanical factors such as acidic foods, toothbrush abrasion, and cold stimuli.

Exposure of dentin can result from attrition, mastication, erosion, abfractions, gingival recession, and improper brushing. Treating DH involves occluding exposed dentinal tubules, achieved through various methods including physical and chemical tubule occlusion, nerve desensitization, and photo biomodulation.

Iontophoresis is a non-invasive technique using an electric field to enhance local and systemic drug delivery in dentistry, facilitating the penetration of drugs like fluoride and lidocaine into enamel, dentin, and oral tissues. This method leverages a low current to drive ionized drugs directly to targeted areas without systemic side effects.

Biomin, an inorganic biocompatible glass compound, contains calcium, fluoride, phosphate, and silica, promoting fluorapatite formation and effective dentinal tubule occlusion. Studies highlight its superior efficacy compared to other treatments for reducing DH. The market offers various options, including SLS-free toothpastes like perfora, which provide a gentler alternative for sensitive teeth.

This study aims to compare the effectiveness of iontophoresis alone and in combination with Biomin and perfora toothpastes in managing DH, focusing on their ability to alleviate symptoms and promote oral health.
 
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