| CTRI Number |
CTRI/2026/03/105565 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial to compare Regular Toothbrushing With and Without a Portable Electric Oral Irrigator in Reducing Bleeding Gums Among Adults with Gum Inflammation |
|
Scientific Title of Study
|
Efficacy Of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Adults with Gingivitis-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 |
DrMahadevan M |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College Thiruvananthapuram |
| Address |
Department of Periodontics Room no A204 Government Dental College Medical College Road Chalakkuzhi,Thiruvananthapuram kerala
Department of Periodontics Room no A204 Government Dental College Medical College Road,Chalakkuzhi,
Thiruvananthapuram kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8547850397 |
| Fax |
|
| Email |
mahumahadevan12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K C Ajithkumar |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College Thiruvananthapuram |
| Address |
Department of Periodontics Room no A200 Government Dental College Medical College Road Chalakkuzhi Thiruvananthapuram kerala
Department of Periodontics Room no A200 Government Dental College Medical College Road Chalakkuzhi Thiruvanthapuram kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9846068227 |
| Fax |
|
| Email |
ajitkesavan73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K C Ajithkumar |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College Thiruvananthapuram |
| Address |
Department of Periodontics Room no A200 Government Dental College Medical College Road Chalakkuzhi Thiruvananthapuram kerala
Department of Periodontics Room no A200 Government Dental College Medical College Road Chalakkuzhi Thiruvanthapuram kerala
KERALA
695011
India |
| Phone |
9846068227 |
| Fax |
|
| Email |
ajitkesavan73@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.Mahadevan M |
| Address |
Department of periodontics Room no A 204,Government Dental College,Medical College road,Chalakkuzhi,Thiruvananthapuram ,Kerala |
| 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 |
| DrMahadevan M |
Government Dental College Thiruvananthapuram |
Room no A204 Department of Periodontics Government DentalCollege Medical College road Chalakkuzhi,Thiruvanathapuram kerala
Thiruvananthapuram
KERALA |
8547850397
mahumahadevan12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commite Government Dental College Thruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Portable electric Oral Irrigator |
Treatment using Manual Tooth brushing along with Oral Irrigators as adjunct.
|
| Comparator Agent |
Tooth Brushing |
Treatment using Manual Tooth brushing alone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Untreated patients diagnosed with Dental Biofilm Induced Gingivitis on intact periodontium according to the 2017 Periodontal Classification
Adults aged 18 years and above regardless of gender.
Individuals in overall good systemic health who practice daily tooth brushing
Possessing a minimum of 20 permanent teeth (excluding third molars) with at least five assessable teeth in each quadrant.
Patients willing to comply with the study protocols and follow-up visits.
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating
Tobacco smokers
Regular users of electric toothbrushes, dental floss, interdental brushes,mouthrinses or other oral hygiene adjuncts
Those wearing orthodontic appliance, removable dentures or large prosthesis.
Individuals who have undergone Professional scaling within the past 6 weeks.
Patients with untreated dental caries,mucosal lesions,xerostomia,oral tumours and systemic disease that may influence Periodontal health.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out if there is any difference in Bleeding Index estimated by Modified Sulcus Index by Mombelli following the use of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Dental Biofilm Induced Gingivitis patients with intact periodontium with baseline 4weeks, 8weeks using UNC-15 probe.
|
To find out if there is any difference in Bleeding Index estimated by Modified Sulcus Index by Mombelli following the use of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Dental Biofilm Induced Gingivitis patients with intact periodontium with baseline 4weeks, 8weeks using UNC-15 probe.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out if there is any difference in the following parameters with the baseline, 4weeks and 8weeks
Modified Gingival Index by Lobene
Bleeding on Probing Percentage (BOP%) using UNC-15 probe
Plaque Index using Silness and Loe index
To assess pain and Dentin hypersensitivity by Numerical Pain Rating Scale
Compliance of patient using manual or electronic dairy
|
baseline 4 weeks 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to clinically evaluate the efficacy of Portable Electric Oral Irrigator as an adjunct to manual toothbrushing in Dental Biofilm induced Gingivitis patients with intact periodontium over a period of 8 weeks.This research aims to provide clearer evidience regarding the intervention of use of Oral Irrigators as an adjunct to manual Tooth brushing over 8 week period,thereby contributing to improved patient care,clinical guidlines and preventive strategies in periodontology |