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CTRI Number  CTRI/2024/09/073401 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of nano hydroxyapatite toothpaste and laser to treat dentin hypersensitivity in patients having tooth sensitivity 
Scientific Title of Study   Efficacy of 10 percent Nanohydroxyapatite Paste as Desensitizer alone and in Combination with 940nm Diode Laser in Treatment of Dentin Hypersensitivity – A Split-Mouth Single Blind Clinical Trial. 
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 Pravika P 
Designation  Post graduate Student  
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor SRM Dental College.
Bharathi Salai, Ramapuram, Chennai TAMIL NADU
Chennai
TAMIL NADU
600089
India 
Phone  9940437909  
Fax    
Email  drpravika1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravi Kumar N 
Designation  Associate Professor 
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor SRM Dental College.
Bharathi Salai, Ramapuram, Chennai TAMIL NADU
Chennai
TAMIL NADU
600089
India 
Phone  9444125488  
Fax    
Email  ravikumn@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr S Mahalaxmi  
Designation  Professor and Head 
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor SRM Dental College.
Bharathi Salai, Ramapuram, Chennai TAMIL NADU
Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax    
Email  mahalaxr@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Dental College Ramapuram, Chennai, Tamilnadu, India. 600089.  
 
Primary Sponsor  
Name  SRM Dental College 
Address  Bharathi salai, Ramapuram, Chennai, Tamilnadu, India. 600089. 
Type of Sponsor  Research institution and hospital 
 
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 Pravika P  SRM Dental College  2nd Floor, Department of Conservative Dentistry and Endodontics, SRM Dental College, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089. Chennai TAMIL NADU
Chennai
TAMIL NADU 
9940437909

drpravika1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM institutional review board   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  10% Nanohydroxyapatite Desensitizer + Diode Laser (940nm)   applied fro 15 mins and laser at 1 watt 
Comparator Agent  Nanohydroxyapatite Desensitizer  10% applied for 15 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Teeth with intact non-carious cervical lesions.

Teeth with gingival recession (Millers class 1 and 2).

Teeth with not more than 1.5 mm loss of dentin in depth which did not require restorative treatment.

Teeth with identical lesions bilaterally.
 
 
ExclusionCriteria 
Details  Teeth with carious lesions.

Previously endodontically treated teeth.

Teeth with cracks, fractures, attrition, mobility, bruxism, gingival recession (Millers class 3 and 4)

Unilateral loss of teeth.

Teeth with restorations for non-carious cervical lesions.

Recent desensitizer application. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of dentin hypersensitivity   14 days, 1,3,6 and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of desensitisation effect.   14 days, 1,3,6 and 9 months 
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="23" 
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 3/ Phase 4 
Date of First Enrollment (India)   25/09/2024 
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="0"
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  

Dentin hypersensitivity is conventionally defined as an episode of short sharp pain arising from exposed dentin after the application of thermal, tactile, chemical, osmotic, or evaporative stimuli, which cannot be caused by any other dental pathology and/or defect. The discomfort caused by dentinal hypersensitivity (DH) is one of the main challenges that dentists face in day to day clinical practice.

Dentin hypersensitivity presents an incidence of about 35% of the population worldwide and occurs mainly between 20 and 50 years of age.

Various treatment modalities exist in the form of desensitizing agents, restorations and laser.

Of the existing materials, no literature evidence of long term complete eradication of dentin hypersensitivity exists.

Recently, a bioactive material namely nano-hydroxyapatite is widely used in dentistry for tooth remineralization and in medicine as a bone substitute.Apart from being bio-compatible, nano-sized particles have similar morphology, structure and crystallinity compared with dental apatite.

Nanohydroxyapatite when applied on the surface of the dentin, it occludes the tubular openings  and  remineralizes the surface. This creates a dual action and the final end product being similar to the inorganic composition of the tooth. On the other hand over a period of time, the stability of the formed layer remains questionable due to wearing off the layer by external factors. Hence, in order to stabilize and to create an effective barrier, adjuvants has been recommended to be used along with desensitizing agent for management of dentin hypersensitivity.

One such is the use of laser.

Laser is been reported to play a noticeable role in treating hypersensitive dentin and providing consistent and repeated results by altering the surface by melting and resolidifying the surface and seals the exposed dentinal tubules by coagulation of proteins. However, direct irradiation of exposed dentin with laser would result in the propagation of the laser beam directly to the underlying pulpal tissue resulting in generation of heat causing undesirable effects on the tissues due to low absorption coefficients of diode lasers in dentin.

Hence to bring in the synergic effect and to overcome each individual drawback, combination of both 10% nanohydroxyapatite desensitizer and 940nm diode laser irradiation have been attempted. Though the literature evidence exists with this combination, the application protocol is standardized to only once. So this questions about the actual depth of penetration of the desensitizer into the dentinal tubules and its stability over a period of time. Hence this clinical study was undertaken to explore the effects of desensitizing agent by applying it for a continued period of time followed by application of laser for prolonged desensitizing effect.

As there are no previous literature reports on the detailed exploration of synergistic effect of 10% nanohydroxyapatite desensitizer followed by application of 940nm diode laser on long term efficacy for the treatment of dentin hypersensitivity, this present clinical study was undertaken  to  evaluate its  efficacy and longevity. The proposed null hypothesis is that there will be no reduction in postoperative sensitivity, immediately after treatment and at 14th day,1,3,6 and 9 months for the patients treated with the application of 10%  nanohydroxyapatite desensitizer and 940nm diode laser. 
 
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