| CTRI Number |
CTRI/2025/03/082566 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of manual toothbrushes with flat, zig-zag and criss-cross shaped bristles on mechanical plaque control among participants aged 20-25 years old in Nellore city- A randomized clinical trial |
|
Scientific Title of Study
|
Comparative efficacy with manual toothbrushes with flat, zig-zag and criss-cross shaped bristles on mechanical control among patients aged 20-25 years old in Nellore city- A randomized clinical 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 |
Tikkavarapu Manogna Reddy |
| Designation |
Postgraduate |
| Affiliation |
Narayana dental college and hospital, Nellore , Andhra Pradesh |
| Address |
Narayana dental college and hospital, Nellore, Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9490903469 |
| Fax |
|
| Email |
manognareddy1922@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RVS KRISHNA KUMAR |
| Designation |
HEAD OF THE DEPART,MENT |
| Affiliation |
Narayana dental college and hospital, Nellore, Andhra Pradesh |
| Address |
Narayana dental college and hospital, Nellore, Andhra Pradesh.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9885291980 |
| Fax |
|
| Email |
drkkmds@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Tikkavarapu Manogna Reddy |
| Designation |
Postgraduate |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL,CHINTAREDDY PALEM,NELLORE,ANDHRAPRADESH |
| Address |
Narayana dental college and hospital, Nellore, Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9490903469 |
| Fax |
|
| Email |
manognareddy1922@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and hospital, Nellore, Andhra Pradesh, 524003, India |
|
|
Primary Sponsor
|
| Name |
Tikkavarapu Manogna Reddy |
| Address |
Narayana dental college and hospital, Nellore, Andhra Pradesh,524003 |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrTikkavarapu Manogna Reddy |
Narayana dental college and hospital |
Chintareddypalem, Nellore, department of public health dentistry
Nellore
ANDHRA PRADESH |
9490903469
manognareddy1922@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee , Narayana dental college and hospital |
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 |
| Comparator Agent |
Flat Bristle Tooth Brush
Zig-Zag Bristle Tooth Brush
Criss-Cross Bristle Tooth Brush
|
frequency: once
duration:6 weeks
|
| Intervention |
Flat Bristle Tooth Brush
Zig-Zag Bristle Tooth Brush
Criss-Cross Bristle Tooth Brush |
frequency: once
duration 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Good oral health,
six tooth excluding third molar in each quadrant with no crowns, orthodontic appliances
No oral lesions, No periodontal pocket ≥3 mm or attachment loss ≥2 mm |
|
| ExclusionCriteria |
| Details |
Moderate to severe gingivitis patients.
Any systemic illness
Muco -gingival problem
Smoking habit
Fixed prostheses |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gingivitis |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque score |
45 days |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/04/2025 |
| 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="1"
Days="15" |
|
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
|
Dental plaque is the primary causative factor for the initiation and development of
dental caries and periodontal disease . Plaque as a biofilm gets attached to the teeth
and on the denture surface, leading to the destruction of the supporting structures of
the teeth, namely, the gingiva, cementum, periodontal ligament, and alveolar bone . Plaque control facilitates the return of the health for patients with gingivitis and
periodontitis. It is effectively influenced by a number of individual‑and
material‑based factors. The factors are based on the design of the toothbrush, the skill
of the individual using the brush, and tooth brushing frequency and duration of use .Many types of bristle designs are commercially available. They are toothbrushes with
flat bristle, multilevel bristle, rippled (zig-zag) bristle, angled or crisscrossed bristle,
V-shaped bristle, spiral filament bristle, and tapered filament design. Effective plaque control is essential for the removal of dental plaque and its
accumulation on the teeth and adjacent gingival surface. Manual toothbrushes are an essential part of oral hygiene for primary prevention
and the bristle designs play a role in removing plaque efficiently and so
maintaining healthy gingival conditions.so far, there are few studies investigated
the effectiveness of different bristles on mechanical plaque control. So there is a
need to conduct a study. |