| CTRI Number |
CTRI/2019/11/022150 [Registered on: 26/11/2019] Trial Registered Prospectively |
| Last Modified On: |
14/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF POLISHING AGENTS TO CHECK PLAQUE ACCUMULATION IN GUM DISEASE |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF GLYCINE POWDER AIR POLISHING AND PROPHYLACTIC PASTE IN REDUCTION OF PLAQUE ACCUMULATION IN GINGIVITIS PATIENTS A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Georgina G Ettiyil |
| Designation |
PG Student |
| Affiliation |
SHDCH, Hassan |
| Address |
Room no 5
Department of Periodontics
Sri hasanamba dental college and hospital, Vidya nagar, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
|
| Fax |
|
| Email |
georgina.ettiyil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha M B |
| Designation |
Professor and Head of the department |
| Affiliation |
SHDCH, Hassan |
| Address |
Room no 5
Department of Periodontics
Sri hasanamba dental college and hospital, Vidya nagar, Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
|
| Fax |
|
| Email |
harshamb@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Georgina G Ettiyil |
| Designation |
PG Student |
| Affiliation |
SHDCH, Hassan |
| Address |
Room 5
Department of Periodontics
Sri Hasanamba college of dental sciences and hospital
Vidya Nagar
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
|
| Fax |
|
| Email |
georgina.ettiyil@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYA NAGAR, HASSAN |
| Type of Sponsor |
Research institution and hospital |
|
|
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 GEORGINA G ETTIYIL |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYA NAGAR, HASSAN, 573201
Hassan
KARNATAKA |
9449673144
georgina.ettiyil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GLYCINE POWDER |
GLYCINE POWDER AIR POLISHING FOR GINGIVITIS PATIENTS |
| Comparator Agent |
PROPHYLACTIC PASTE |
PROPHYLACTIC PASTE POLISHING FOR GINGIVITIS PATIENTS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Willingness to comply with the study protocol
2. Subjects who are diagnosed with chronic generalized gingivitis
3. Subjects in the age range of 18-55 years
4. Systemically healthy individuals
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are smokers.
2. Pregnant and lactating women
3. Patients under antibiotic therapy in the past 6 months
4. Patients who have undergone any periodontal therapy within the previous 6 months.
5. Unable or not willing to comply with the study protocol
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EVALUATION OF PLAQUE RETENTION IN GINGIVITIS PATIENTS |
ANALYSIS AT BASELINE 0 DAY AND AT 14TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
EVALUATION OF:
1 PLAQUE INDEX
2 GINGIVAL INDEX |
ANALYSIS AT BASELINE 0 DAY AND AT 14TH DAY AFTER INTERVENTION |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
29/11/2019 |
| Date of Study Completion (India) |
01/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
PUBLISHED
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THE STUDY AIMS AT EVALUATION OF GLYCINE POWDER AIR POLISHING AND PROPHYLACTIC PASTE POLISHING IN REDUCTION OF PLAQUE ACCUMULATION IN GINGIVITIS PATIENTS AS AN ADJUNCT TO SCALING. EVALUATION IS DONE AFTER 14 DAYS OF INTERVENTION. |