| CTRI Number |
CTRI/2024/06/068729 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of biomin toothpaste with potassium nitrate toothpaste in patients with periodontitis and tobacco chewing habit. |
|
Scientific Title of Study
|
Comparative evaluation of clinical efficacy and patient related outcome measures (PROM) of Biomin containing dentifrice with potassium nitrate dentifrice in patients with periodontitis and tobacco chewing habit.-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 |
Jinal Bharat Patil |
| Designation |
1st year PG student |
| Affiliation |
K.M.SHAH Dental College and Hospital |
| Address |
Department of Periodontology, Room no.7,K.M.Shah Dental college and Hospital
Sumandeep Vidyapeeth Deemed to be University
Vadodara
GUJARAT
391760
India |
| Phone |
08087533487 |
| Fax |
|
| Email |
jinal66patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Monali Shah |
| Designation |
Professor and head |
| Affiliation |
K.M.SHAH Dental College and Hospital |
| Address |
Department of Periodontology, Room no.7, K.M.Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University
Vadodara
GUJARAT
391760
India |
| Phone |
9824003228 |
| Fax |
|
| Email |
smonali2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jinal Bharat Patil |
| Designation |
1st year PG student |
| Affiliation |
K.M.SHAH Dental College and Hospital |
| Address |
Department of Periodontology, Room no.7, K.M.Shah Dental College and Hospital,Sumandeep Vidyapeeth Deemed to be University
Vadodara
GUJARAT
391760
India |
| Phone |
08087533487 |
| Fax |
|
| Email |
jinal66patil@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M.SHAH Dental college and hospital Sumandeep Vidyapeeth Deemed to be University, Waghodia, Piparia, Gujarat-391760 |
|
|
Primary Sponsor
|
| Name |
Jinal Patil |
| Address |
K.M.SHAH Dental college and hospital Sumandeep Vidyapeeth Deemed to be University, Waghodia, Piparia, Gujarat-391760 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| DrJinal Patil |
K.M.SHAH Dental College and Hospital |
Room no.7, Department of Periodontology,K.M.SHAH Dental College and Hospital,Sumandeep Vidyapeeth Deemed to be University, Waghodia, Piparia-391760
Vadodara
GUJARAT |
08087533487
jinal66patil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biomin containig dentifrice |
Post scaling hypersensitivity will be checked and patients will be given biomin containing dentifrice. Patient will be advised to brush teeth twice daily and follow up will be done at 3 days,24 days and 45 days |
| Intervention |
Potassium Nitrate containing dentifrice |
Post scaling hypersensitivity will be checked and patients will be given potassium nitrate containing dentifrice. Patient will be advised to brush teeth twice daily and follow up will be done at 3 days,24 days and 45 days
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients in age range of 30-60
Minimum of 24 natural teeth
Habit of tobacco chewing from minimum last one year
Stage I/II periodontitis
|
|
| ExclusionCriteria |
| Details |
Not willing for participation in the study.
Smoking habits
Participants having unrestored carious lesions or non carious cervical lesions.
Periodontal therapy in last 6 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 |
Visual analogue scale
Likert scale |
3 Days
24 Days
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival index
Plaque index
Bleeding on probing
Probing depth
Clinical attachment level
|
3 Days
24 Days
45 Days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2024 |
| 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="0"
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
|
Tobacco consumption is prevalent and have
detrimental effect on teeth and periodontium. Till
date,
many
studies
have
been
done
independently
on
effectiveness
of
different
dentifrice on gingival
health and dentinal hypersensitivity for the non habit patients. Patient-centered
reported outcome (PROs) measures, have been progressively introduced in
periodontal and implant research. Further, patient-centeredness, when backed up
properly, can improve the overall quality of care and pave the way to support
patients’ and their doctors’ decisions. |