| CTRI Number |
CTRI/2020/03/023966 [Registered on: 16/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF DESENSITIZING AGENTS IN REDUCING THE DENTINAL HYPERSENSITIVITY FOLLOWING VITAL TOOTH PREPARATION |
|
Scientific Title of Study
|
EFFECT OF SILVER DIAMINE FLUORIDE,POTASSIUM NITRATE AND GLUTARALDEHYDE ON REDUCING THE POST VITAL TOOTH PREPARATION HYPERSENSITIVITY- A DOUBLE BLINDED RANDOMISED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K SAVITHA |
| Designation |
POSTGRADUATE |
| Affiliation |
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE |
| Address |
Department of Prosthodontics, Crown and Bridge
Indira Gandhi Institute of Dental Science
Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8015242787 |
| Fax |
|
| Email |
savitha.kumar394@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P S Manoharan |
| Designation |
Head of the Department |
| Affiliation |
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE |
| Address |
Department of Prosthodontics, Crown and Bridge
Indira Gandhi Institute of Dental Science
Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8015242787 |
| Fax |
|
| Email |
manoharanps@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
K SAVITHA |
| Designation |
POSTGRADUATE |
| Affiliation |
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE |
| Address |
Department of Prosthodontics, Crown and Bridge
Indira Gandhi Institute of Dental Science
Sri Balaji Vidyapeeth
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8015242787 |
| Fax |
|
| Email |
savitha.kumar394@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR K SAVITHA |
| Address |
DEPARTMENT OF PROSTHODONTICS, CROWN AND BRIDGE,
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES,
SRI BALAJI VIDHYAPEETH,
PILLAYARKUPPAM,
PONDICHERRY -607402 |
| 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 K SAVITHA |
INDIRA GANDHI INSITUTE OF DENTAL SCIENCES |
Department of Prosthodontics, Crown and Bridge
Pondicherry
PONDICHERRY |
8015242787
savitha.kumar394@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desensitizing agents |
Three Desensitizing agents-GLUMA,POTASSIUM NITRATE,Silver diamine fluoride |
| Comparator Agent |
water |
placebo |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Vital teeth in need of Fixed Prosthetic Restorations.
2. Age above 25 years.
3. Teeth free of Decay /Any other Pathologies.
4. Co-Operative patients.
|
|
| ExclusionCriteria |
| Details |
1. Age less than 25 years.
2. Pregnant/Breast feeding.
3. Non Cooperative patients
4. Allergic to Desensitizers.
5. Non Vital tooth.
6. Hypersensitive tooth on testing.
7. Any Periodontal Diseases.
8. Carious Tooth.
9. Pain related to the Oro facial region.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the reduction of Hypersensitivity following a vital tooth preparation using Silver Diamine Fluoride, Potassium nitrate and Glutaraldehyde
a. after Preparation b. after applying Desensitizer c. Prior to Permanent Cementation d. after 30 days.
|
after Local anesthetic effect have gone
Afer application of desensitizing agents
Before permanent cementation
After a follow up period of 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Find out the Correlation between the Remaining Dentin Thickness and Sensitivity.
To observe for any Incidences of Debonding after Permanent Cementation.
To Observe for any incidences of Hypersensitivity after Permanent Cementation and During the Follow up period.
|
after Local anesthetic effect have gone
Afer application of desensitizing agents
Before permanent cementation
After a follow up period of 30 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "119"
Final Enrollment numbers achieved (India)="119" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/03/2020 |
| Date of Study Completion (India) |
21/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
GOING TO GET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Within the limitations of the study ,the
following conclusions were drawn:
1. Desensitizers used in this
study are effective in desensitizing the prepared vital tooth.
2. Among the desensitizers used, Silver
diamine fluoride seem to be more
effective after application, prior to cementation of the prosthesis and after a
follow up period of 30 days.
3. There were no debonding of any
fixed prosthesis noted during the period of the study.
|