| CTRI Number |
CTRI/2022/11/047246 [Registered on: 14/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To check cleaning effect of v-cut charcoal toothbrush with already available v cut toothbrush in patients with braces. |
|
Scientific Title of Study
|
Effectiveness of New Activated Charcoal Orthodontic Toothbrush On Plaque Removal in Orthodontic Patients Using Orthodontic Plaque Index And Gingival Index: A Randomized Cross-Over Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakher Saini |
| Designation |
Post-Graduate Student |
| Affiliation |
Inderprastha Dental College and Hospital, Uttar Pradesh |
| Address |
Department of orthodontics and dentofacial orthopaedics, TF2 Third floor, Inderprastha dental college and hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
7683091992 |
| Fax |
|
| Email |
drprakhersaini@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Paul |
| Designation |
Director, Principal, Professor, and H.O.D. |
| Affiliation |
Inderprastha Dental College and Hospital, Uttar Pradesh |
| Address |
Department of orthodontics and dentofacial orthopaedics, Inderprastha Dental college and hospital, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9810292498 |
| Fax |
|
| Email |
drrahulpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakher Saini |
| Designation |
Post-Graduate Student |
| Affiliation |
Inderprastha Dental College and Hospital, Uttar Pradesh |
| Address |
Department of orthodontics and dentofacial orthopaedics, TF2 Third floor, Inderprastha dental college and hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
7683091992 |
| Fax |
|
| Email |
drprakhersaini@outlook.com |
|
|
Source of Monetary or Material Support
|
| Inderprastha Dental College and Hospital, Sahibabad, Ghaziabad 201010 |
|
|
Primary Sponsor
|
| Name |
Dr Prakher saini |
| Address |
Inderprastha Dental College and Hospital, Sahibabad, Ghaziabad 201010 |
| 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 |
| Dr Prakher saini |
Inderprastha Dental College and Hospital, Sahibabad, Ghaziabad 201010 |
Department of Orthodontics and Dentofacial Orthopaedics, TF-2, Third Floor, Inderprastha Dental College and Hospital, Sahibabad, Ghaziabad 201010
Ghaziabad
UTTAR PRADESH |
7683091992
drprakhersaini@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
charcoal bristle toothbrush |
The oral hygiene of patients using a Charcoal-infused V cut Orthodontic toothbrush will be compared to the oral hygiene of patients using a non-orthodontic charcoal-infused toothbrush. Patients will be asked to brush twice daily for 2 minutes, once in the morning after breakfast and secondly just before retiring to bed, which they will be using for 6 weeks |
| Intervention |
Charcoal infused V cut Orthodontic tooth brush |
This is a new tooth brush which will be given to patients undergoing orthodontic treatment who find it difficult to maintain oral hygiene. The oral hygiene of these patients after using this brush will be compared to oral hygiene of patients using conventional orthodontic V cut toothbrush and charcoal infused flat design conventional non-orthodontic toothbrsh. Patients will be asked to brush twice daily for 2 minutes once in morning after breakfast and secondly just before retiring to bed which they will be using for 6 weeks |
| Comparator Agent |
Conventional v cut orthodontic toothbrush |
Oral hygiene of patients using Charcoal infused V cut Orthodontic toothbrush will be compared to oral hygiene of patients using Conventional v cut orthodontic toothbrush. Patients will be asked to brush twice daily for 2 minutes once in morning after breakfast and secondly just before retiring to bed which they will be using for 6 weeks. |
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient with fair oral hygiene index
Age between 15 and 30 years
No history of antibiotics, steroids, or NSAIDs in the past two months
Each subject must have plaque index score <1 (orthodontic modified Sillness and loe).
|
|
| ExclusionCriteria |
| Details |
Presence of any local or systemic disease or immunosuppressant drug therapy.
Use of antibiotics, steroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) therapy within the past two months or during the study
Mentally handicapped subjects
Subjects with poor manual dexterity
Poor compliance subjects
Using antibacterial mouth rinses
Patients with a history of allergies to food dyes (especially contents of DPI- AlphaPlac, study toothpaste)
Pregnancy
Previous or current use of powered or manual orthodontic toothbrushes
Subject using Smoking, tobacco products
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this study is to evaluate the effectiveness of a new activated charcoal orthodontic toothbrush designed with a conventional orthodontic toothbrush and conventional charcoal infused toothbrushes on better plaque control in patients undergoing fixed orthodontic treatment when compared to Conventional v cut orthodontic toothbrush. |
21th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Value of orthodontic plaque index before and after toothbrushing. |
baseline, 2nd week, 4th week, 6th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2022 |
| Date of Study Completion (India) |
05/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
§ Recently,
toothbrushes with charcoal-infused nylon bristles have been introduced.
Charcoal, as a chemical, is a good absorbent neutralizer for toxins, poisons,
and noxious gases and hence reduces bacterial contamination. A study
conducted in 2017 by Lee et al. found that aerobic microbial
contamination of charcoal toothbrushes was half when compared to non-charcoal-infused toothbrushes. Also, charcoal-infused
bristles demonstrated minor wear and more plaque removal than conventional
nylon bristles. Therefore, introducing charcoal-infused
bristles with orthodontic toothbrushes may improve oral hygiene maintenance
with lesser effort. Hence, to evaluate the efficacy of charcoal-infused
bristles in orthodontic patients, which may be a better alternative for
providing good oral hygiene, especially for orthodontic patients, this study
is undertaken.
§ This
study may prove to be of assistance and patient acceptance towards having
good oral hygiene, with more predictable outcomes in Orthodontic treatment.
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