| CTRI Number |
CTRI/2018/05/014258 [Registered on: 31/05/2018] Trial Registered Prospectively |
| Last Modified On: |
21/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to compare the effect of three desensitizing agents to reduce hypersensitivity in tooth with cervical abrasion. |
|
Scientific Title of Study
|
Efficacy of three desensitizing agents to reduce cervical dentin hypersensitivity: a randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Bantawa |
| Designation |
MDS PG Resident, Dept. of Conservative Dentistry and Endodontics |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Dept. of Conservative Dentistry and Endodontics, Room no. 8, CODS, BPKIHS, Dharan-18, Nepal
7053
Other |
| Phone |
9842085124 |
| Fax |
|
| Email |
candleshikha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mannu Vikram |
| Designation |
Additional Professor, Dept of Conservative Dentistry and Endodontics, BPKIHS |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Dept. of Conservative Dentistry and Endodontics, Room no. 8, CODS,BPKIHS, Dharan-18, Nepal
7053
Other |
| Phone |
9852049808 |
| Fax |
|
| Email |
drmannuvikram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Bantawa |
| Designation |
MDS PG Resident, Dept. of Conservative Dentistry and Endodontics, BPKIHS |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Dept. of Conservative Dentistry and Endodontics, Room no. 8, CODS,BPKIHS, Dharan-18, Nepal
7053
Other |
| Phone |
9842085124 |
| Fax |
|
| Email |
candleshikha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Conservative Dentistry and Endodontics, BP Koirala Institute of Health Sciences, Dharan, Nepal |
|
|
Primary Sponsor
|
| Name |
Shikha Bantawa |
| Address |
Bpkihs, Dharan-18, Nepal |
| Type of Sponsor |
Other [Thesis materials financially sponsored by principal author] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shikha Bantawa |
BP Koirala Institute of Health Sciences |
Dept. of Conservative Dentistry and Endodontics, Room No. 8, College of Dental Surgery,BPKIHS, Dharan-18, Nepal
|
9842085124
candleshikha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instirutional Review Committee, BPKIHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypersensitive cervical abrasion in any tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gluma (Heraeus Kulzer, Armonk, NY, USA) |
A few drops of agent will be applied with a applicator tip using a gentle but firm rubbing motion. After 30 seconds, the area will be dried thoroughly until the fluid disappears and the surface would not be shinny. |
| Intervention |
Propolis extract (HERB PHARM, India) |
Propolis will be applied with a brush and left undisturbed at the site for 5 minutes. |
| Intervention |
Vivasens (Ivoclar Vivadent AG, Schaan, Liechtenstein) |
A few drops of agent will be applied using a disposable brush provided. Area will be air dried for 10 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults of 18 years of age or above and in general good health with hypersensitive teeth and cervical abrasion.
Dentin exposed permanent tooth, which does not require any restorative regimen.
Participants who are willing to take part in the study.
|
|
| ExclusionCriteria |
| Details |
Patient currently on desensitizing therapy.
Allergies and idiosyncratic responses to product ingredients.
Systemic conditions predisposing to dentin hypersensitivity (e.g., chronic acid regurgitation).
Teeth or supporting structures with any other painful pathology or defects.
Removable prostheses or crowned teeth.
Extensively restored teeth and those with restorations extending into the test area.
Presence of radiographic evidence of periapical pathology and symptomatic adjacent tooth.
Patient with recent history of trauma.
Recent intake of analgesic and mind altering drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the reduction of
cervical dentin hypersensitivity after the application of desensitizing agents. |
Immediate, 1 week, 1 month and 2 months after the application of desensitizing agents. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate immediate, 1 week, 1 month and 2 months relief from dentin hypersensitivity. |
Immediate, 1 week, 1 month and 2 months after the application of desensitizing agents. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="0"
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 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2018 |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized clinical trial, double blind, parallel group, hospital based comparing the efficacy of three desensitizing agents: gluma, vivasens and propolis in reducing the cervical dentin hypersensitivity. The primary outcome measure is to compare the reduction of hypersensitivity of cervical abrasion after application of desensitizing agents. The secondary outcome will be to evaluate the effect of desensitizing agents: immediately, 1 week, 1 month and 2 months of application of desensitizing agents. |