| CTRI Number |
CTRI/2021/03/031812 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
14/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate the Efficacy & Safety of DENTORA® Gel in the management of Infectious-inflammatory diseases of the the oral cavity. |
|
Scientific Title of Study
|
A prospective, Interventional, Randomized, parallel, active-controlled comparative clinical study to evaluate the Efficacy & Safety of DENTORA® Gel in the management of Infectious-inflammatory diseases of the periodontium and mucosa of the oral cavity. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/APL/0701/111 version 01 dated 01 Jul 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashank Tiwari |
| Designation |
Principal investigator |
| Affiliation |
M.V. Hospital and research centre |
| Address |
Room- 02, Dental department 314/30, Mirza mandi chowk, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7007208089 |
| Fax |
|
| Email |
drs.tiwari@yahoo.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Harish S |
| Designation |
Director Operation |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 and 18, ICBio Tower Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Harish S |
| Designation |
Director Operation |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 and 18, ICBio Tower Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| AGIO PHARMACEUTICALS LTD. |
|
|
Primary Sponsor
|
| Name |
AGIO PHARMACEUTICALS LTD |
| Address |
H.O.: A-38, Nandjyot Industrial Estate,
Kurla- Andheri Road, Safedpool
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr shashank |
M. V. Hospital and research centre |
Room no-02 dental department 314/30 Mirza Mandi Chowk lucknow
Lucknow
UTTAR PRADESH |
7007208089
drs.tiwari@yahoo.in |
| Dr Subash T S |
Mysore medical college and research Institute. |
Department to Dentistry
Irwin road Mysore
Mysore
KARNATAKA |
9845129509
tssubhashrao@gmail.com |
| Dr Sheetal B |
Santosh Hospital |
#6/1, Promenade road behind Coler Park Near Good will School
Bangalore
KARNATAKA |
9945620630
ssaklecha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe for M. V. Hospital and research center |
Approved |
| Institutional ethics committee Mysore medical college and research institute |
Approved |
| Santosh Hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DENTORA® GEL |
GEL as a thin layer on the gums twice daily using a finger or swab.(As applicable)
The treatment duration will be 7 days |
| Comparator Agent |
Metrogyl Denta |
GEL as a thin layer on the gums twice daily using a finger or swab.(As applicable)
The treatment duration will be 7 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Both males and Females of Age ≥ 6 years to 50, without any known allergy to commercial dental products or cosmetics.
2.Subject who meets with anyone of the following Infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity
|
|
| ExclusionCriteria |
| Details |
1.Subjects who report history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease , chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients.
2.Subjects with eating disorders, uncontrolled Gastroesophageal reflux disease GERD or Acid Reflux, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity.
3.Subjects with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain.
4.Long-term daily use more than 7 consecutive days of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of Tooth sensitivity reduction in Mean Cold Air VAS Stimulus Score using Heft parker Visual Analog Scale
2. Evaluation of Reduction in gingivitis levels (bleeding on probing) assessed by the Gingival Bleeding Index (GBI) |
baseline day1 day 5, day 7 and day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of the changes in deep tooth stains from screening to EOT by Lobene Stain index
2.Evaluation of the changes in tooth mobility for loose tooth roots from screening to EOT by mobility grading
3.Improvement in overall oral health performance is assessed by Oral Health Assessment Tool for Dental Screening and Oral care Assessment Guide
4.Incidence and Rate of adverse events |
baseline day1 day 5, day 7 and day 10 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2021 |
| Date of Study Completion (India) |
27/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A prospective, Interventional, Randomized, parallel, active-controlled comparative clinical study to evaluate the Efficacy & Safety of DENTORA® Gel in the management of Infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity.The DENTORA® Gel is used to treat Infectious-inflammatory diseases of the parodontium and mucosa.
Treatment duration will be total 10 days (7 Days treatments and follow up on 10 th Days) | Study will be conducted on 80 subjects in 2 arm Arm-I: – 40 Subjects-DENTORA® GEL Arm-II:– 40 Subjects- Metrogyl Denta |
|