| CTRI Number |
CTRI/2023/07/055540 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Clinical Efficacy Of Different desensitizing Agents At Relieving Dentin Hypersensitivity : A Patient Reported Outcome Based Randomized Clinical Study. |
|
Scientific Title of Study
|
"Comparison of Clinical Efficacy after Single Topical Application of 38 % Silver Diamine Fluoride (SDF), Advantage arrest, Nanoseal and Gluma at Relieving Dentin Hypersensitivity: A Patient-Reported Outcome Based 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 Madhuri Patil |
| Designation |
Associate Professor |
| Affiliation |
M A Rangoonwala college of dental sciences and research centre. |
| Address |
Department of conservative dentistry and endodontics, Room no-305,M A Rangoonwala college of dental sciences and research centre. N Hidayatullah Azam Campus Camp, Pune. N Hidayatullah Azam Campus Camp, Pune. Pune MAHARASHTRA 411001 India |
| Phone |
7507444736 |
| Fax |
|
| Email |
madhuribpatil89@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhuri Patil |
| Designation |
Associate Professor |
| Affiliation |
M A Rangoonwala college of dental sciences and research centre. |
| Address |
Department of conservative dentistry and Endodontics,Room no 305, M A Rangoonwala college of dental sciences and research centre. N Hidayatullah Azam Campus Camp, Pune. N Hidayatullah Azam Campus Camp, Pune. Pune MAHARASHTRA 411001 India |
| Phone |
7507444736 |
| Fax |
|
| Email |
madhuribpatil89@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhuri Patil |
| Designation |
Associate Professor |
| Affiliation |
M A Rangoonwala college of dental sciences and research centre. |
| Address |
Department of conservative dentistry and Endodontics,Room no 305, M A Rangoonwala college of dental sciences and research centre. N Hidayatullah Azam Campus Camp, Pune. N Hidayatullah Azam Campus Camp, Pune. Pune MAHARASHTRA 411001 India |
| Phone |
7507444736 |
| Fax |
|
| Email |
madhuribpatil89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and Endodontics,Room no 305, M A Rangoonwala college of dental sciences and research centre. N Hidayatullah Azam Campus Camp, Pune. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Madhuri Patil |
M A Rangoonwala College of Dental Sciences and Research centre |
Department of conservative dentistry and Endodontics,Room no 305, M A Rangoonwala college of dental sciences and research centre. N Hidayatullah Azam Campus Camp, Pune.
MAHARASHTRA Pune MAHARASHTRA |
7507444736
madhuribpatil89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commitee of MCE society,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental hypersensitivity |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
38% silver diamine fluoride (e-SDF) |
Total duration : 1 minute
The selected hypersensitive tooth will be dried and using a micro-brush a drop of 38% SDF will be applied on the exposed cervical surface of the selected hypersensitive tooth. Do not blow compressed air or rinse while e-SDF is being adsorbed for 1 minute. After waiting for 1 minute ,lightly blot any excess e-SDF with cotton.
|
| Intervention |
38% silver diamine fluoride (SDF) |
The total duration for application: 1 minute
The selected hypersensitive tooth will be dried and using a micro-brush a drop of 38% SDF will be applied on the exposed cervical surface of the selected hypersensitive tooth.
Do not blow compressed air or rinse while e-SDF is being adsorbed for 1 minute. After waiting for 1 minute ,lightly blot any excess e-SDF with cotton. |
| Comparator Agent |
Gluma desensitizer |
The total duration for application: 1 minute
Gluma: will be applied using an applicator tip onto the tooth being treated and allowed to dry for one minute.
|
| Intervention |
Nanoseal |
Nanoseal mixture of liquid A (aqueous dispersion of nanoparticulate calcium-fluoroaluminosilicate glass) and B (phosphoric acid solution)will be mildly applied (without rubbing) to the hypersensitive area for at least 20 s using a microapplicator and then washed with water. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients who agreed to participate and provide written consent for the study
Age group - 20-50 years
Participant who have at least one non-carious cervical lesion (NCCL’s) i.e. incisor, cuspid or premolar with a buccal cervical defect and clinical hypersensitivity in response of minimum 2 on a visual analogue scale (VAS).
Shallow NCCL’s- lesions that had a shallow depth (less than or equal to 0.5 mm) but their breadth and height dimensions were greater than 1.0 mm.These lesions exhibited minimal dentine exposure.
Concave NCCL’s- lesions that had a greater depth than 0.5mm. Concave NCCLs did not demonstrate well-defined internal line angle. Instead, the floor of these lesions was continously curved.
Generally healthy gum tissue surrounding the tooth (no ulceration or leukoplakia)
|
|
| ExclusionCriteria |
| Details |
Any subject that does not fall under the inclusion criteria were excluded
Using any desensitizing agent within one month
Pharmacotherapeutic histories that may compromise the protocol - including the chronic use of anti-inflammatory, analgesic and mind-altering drugs
Pregnant or lactating
Periodontal surgery in the preceding 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the primary outcome is the success of the treatment. Success will be measured as reduction in the dentinal hypersensitivity using Visual Analogue scale (VAS) after 1,4 & 8 weeks interval |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome will be patient satisfaction.
Patients will complete pain assessment (labelled magnitude scale) treatment questionnaire at baseline & follow-up visits.
Four factors will be considered : duration,intensity, tolerability & description) |
2 months |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentine in response to stimuli typically thermal, evaporative, tactile, osmotic or chemical and which cannot be ascribed to any other form of dental defect or pathology (Orehardson & Collins 1987a, Addy 1992).1 It typically affect individuals aged from 20–49 years, with a peak incidence between 30–39 years. The buccal cervical regions of the permanent teeth are the most commonly affected surfaces, with canine, premolar and incisor teeth being more frequently affected than molars. 2,3 The hydrodynamic theory proposed by Brännström M in 1963 is still the most accepted theory used to explain the mechanism of dentin hypersensitivity. According to this theory, open tubules of exposed dentine allow the movement of dentinal fluid within the dentinal tubules, indirectly stimulating the pulp nerves.4 The severity of symptoms does not depend on the breadth and depth of lesions, but on the number of non-occluded tubules exposed to the oral cavity, consequently, the sealing of exposed and patent tubules should reduce or eliminate the pain and discomfort of the patient.5 There are two principal treatment options. These are plugging the dentinal tubules, preventing fluid flow and desensitizing the nerve, making it less responsive to stimulation.6 Occlusion of the dentin tubules is the most common therapeutic approach. Many of the agents in this category result in precipitative intratubular occlusion or in the formation of a smear layer over dentin that blocks entry to the tubules.7,8 As a non-invasive treatment for dentin hypersensitivity, 38% SDF was first introduced into the United States (US) market in 2015. The silver particles on the surface and within the tubules decrease tubule diameter markedly and thus reduce tubular fluid movement, an established mechanism to relieve dentin hypersensitivity.9Nanoseal® (Nippon Shika Yakuhin, Shimonoseki, Japan) a tooth surface coating product to clinically reduce dentin hypersensitivity, is composed of two liquids: an aqueous dispersion of nanoparticulate calcium-fluoroaluminosilicate glass and phosphoric acid solution). After mixing the two liquids, calciumfluoroaluminosilicate glass particles begin to aggregate by the acid-base reaction. The aggregates occlude the dentinal tubules like a type of silicate cement filling. 10 Gluma (Heraeus Kulzer, Armonk, NY, USA) a non-fluoride product, is one of the systems marketed solely for the treatment of dentin hypersensitivity. Gluma consists of glutaraldehyde-hydroxyethyl-methacrylate and prevents hypersensitivity by reducing dentinal permeability and clotting the proteins and amino acids in the peripheral dentinal tubules. This inhibits the flow of fluid through the tubules, which is the cause of the sensitivity.11 The patient’s experience has become increasingly important in evaluations of the effectiveness of dental treatments as it complements the dentist evaluations and other measures completed in a more traditional manner.12 However, there are limited well-designed clinical trials that investigate the effectiveness of SDF in reducing dentine hypersensitivity. Hence, the present clinical study will be intended to assess the efficacy of four different desensitizing agents in providing relief from dentin hypersensitivity and to help the clinician choose the most effective treatment solution for dentin hypersensitivity. |