| 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
|
|
|
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
|
|
|
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. |