| CTRI Number |
CTRI/2024/03/064425 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Gluma and Er,Cr:YSGG Laser in patients with tooth hypersensitivity |
|
Scientific Title of Study
|
Comparative assessment on effect in hypersensitivity in Non-Carious Cervical Lesions (NCCLs) restored with adhesive resin after pre-treatment with Gluma and Er,Cr:YSGG Laser VS without pre-treatment : A Randomized Controlled 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 Sagarika Sortey |
| Designation |
MDS Student |
| Affiliation |
Department of Conservative Dentistry and Endodontics, VSPM DC RC |
| Address |
VSPM Dental College and Research Centre hingna road digdoh hills police nagar Nagpur
digdoh
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9561449305 |
| Fax |
|
| Email |
saaga.2297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gautam Badole |
| Designation |
Guide and Associate Professor |
| Affiliation |
Department Of Conservative Dentistry and Endodontics, VSPM DC RC |
| Address |
VSPM Dental College and Research Centre hingna road digdoh hills police nagar Nagpur
digdoh
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9665410655 |
| Fax |
|
| Email |
badole_g15@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagarika Sortey |
| Designation |
MDS Student |
| Affiliation |
Department of Conservative Dentistry and Endodontics, VSPM DC RC |
| Address |
VSPM Dental College and Research Centre hingna road digdoh hills police nagar Nagpur
digdoh
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9561449305 |
| Fax |
|
| Email |
saaga.2297@gmail.com |
|
|
Source of Monetary or Material Support
|
| VSPM Dental College and Research Centre hingna road digdoh hills police nagar Nagpur-440019 |
|
|
Primary Sponsor
|
| Name |
Dr. Sagarika Sortey |
| Address |
VSPM Dental College and Research Centre hingna road digdoh hills police nagar Nagpur
|
| 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 Sagarika Sortey |
Department Of Conservative Dentistry And Endodontics, Vspm Dental College and Research Centre |
VSPM Dental College and Research Centre hingna road digdoh hills police nagar Nagpur- 440019
Nagpur
MAHARASHTRA |
9561449305
saaga.2297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College And Research Centre Insititutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dentinal Hypersensitivity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Er,Cr:YSGG laser |
after pretreatment with laser, non-carious lesion restored with adhesive resin. |
| Intervention |
Gluma |
after pretreatment with Gluma, non-carious lesion restored with adhesive resin. |
| Comparator Agent |
no pretreatment |
without pretreatment non-carious lesions restored with adhesive resin |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Premolar with Class 3 Non-Carious Cervical Lesion showing hypersensitivity.
Patient showing willingness to participate in the study for 1 month.
|
|
| ExclusionCriteria |
| Details |
i. Carious lesion on the selected or neighbouring tooth.
ii. Restorations on the selected tooth.
iii. Any desensitizing therapy on the selected tooth during the last 6 months
iv. Periodontal surgery within last 3 months
v. Nonvital tooth, cracked tooth syndrome
vi. Tender tooth in the same quadrant as the hypersensitive teeth.
vii. Patients undergoing orthodontic treatment
viii. Pregnant/lactating females.
ix. Smokers, alcoholics.
x. Patients taking antibiotics/analgesics/anti-inflammatory/anti-depressive drugs, patients having cognitive dysfunctions/general communication difficulties.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess the hypersensitivity in Non-Carious Cervical Lesions (NCCLs).
2)To assess the effect in hypersensitivity in Non-Carious Cervical Lesions (NCCLs) restored with adhesive resin after pre-treatment with Gluma and Er,Cr:YSGG laser vs without pre-treatment.
3)To compare the efficacy of Gluma and Er,Cr:YSGG laser in reducing hypersensitivity in Non-Carious Cervical Lesions (NCCLs) restored with adhesive resin vs without pre-treatment.
|
VAS scale will be used to measure the pain response before treatment 24hrs post restoration 15 days and 1 month.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcome |
nil |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
this study is a randomised, parallel group controlled trial assessing and comparing reduction in hypersensitivity in Non Carious Cervical Lesions restored with
adhesive resin after pre-treatment with Gluma and Er,Cr:YSGG Laser vs without
pre-treatment. This study will be conducted in department of conservative dentistry and endodontics of our institute. The primary outcome will assess the hypersensitivity in Non-Carious Cervical Lesions (NCCLs), the effect in hypersensitivity
in Non-Carious Cervical Lesions (NCCLs) restored with adhesive resin after pre-treatment with
Gluma and Er,Cr:YSGG laser vs without pre-treatment and will compare the efficacy of
Gluma and Er,Cr:YSGG laser in reducing hypersensitivity in Non-Carious Cervical
Lesions (NCCLs) restored with adhesive resin vs without pre-treatment. This study will be conducted over a period of 18-20 months. |