| 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
|
|
|
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
|
|
|
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. |