CTRI Number |
CTRI/2021/07/034947 [Registered on: 16/07/2021] Trial Registered Prospectively |
Last Modified On: |
13/05/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of three different brush designs in orthodontic patients |
Scientific Title of Study
|
Effectiveness of manual,electric and ultrasonic toothbrushes on Streptococcus mutans count in patients undergoing fixed orthodontic treatment: A Randomized Clinical Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shikha |
Designation |
Post Graduate Student |
Affiliation |
Faculty of Dental Sciences, SGT University. |
Address |
Department no.7,Department of Orthodontics and Dentofacial Orthopaedics,Faculty of Dental Sciences,SGT University,
Budhera,Gurugram.
Gurgaon HARYANA 122505 India |
Phone |
8570848597 |
Fax |
|
Email |
ahlawatshikha1408@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mona Prabhakar |
Designation |
Professor |
Affiliation |
Faculty of Dental Sciences,SGT University |
Address |
Department no.7,Department of Orthodontics and Dentofacial Orthopaedics,Faculty of Dental Sciences,SGT University,
Budhera,Gurugram.
Gurgaon HARYANA 122505 India |
Phone |
9810131064 |
Fax |
|
Email |
prabhakarmona@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shikha |
Designation |
Post Graduate Student |
Affiliation |
Faculty of Dental Sciences, SGT University. |
Address |
Department no.7,Department of Orthodontics and Dentofacial Orthopaedics,Faculty of Dental Sciences,SGT University,
Budhera,Gurugram.
Gurgaon HARYANA 122505 India |
Phone |
8570848597 |
Fax |
|
Email |
ahlawatshikha1408@gmail.com |
|
Source of Monetary or Material Support
|
SGT Dental College,Hospital and Research Center,SGT University,Budhera,Gurugram. |
|
Primary Sponsor
|
Name |
SGT University |
Address |
Faculty of Dental Sciences,SGT University,Gurugram-122505 |
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 |
Shikha |
SGT university |
Department no. 7,Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences. Gurgaon HARYANA |
8570848597
ahlawatshikha1408@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURUG RAM,HARYANA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
oral hygiene maintenance in patients with fixed orthodontic appliances(braces). |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Electric and ultrasonic toothbrushes |
The use of electric toothbrushes can offer better fluoride distribution throughout the mouth .The ultrasound moves the bristles on the brush at a high speed and pressure.The toothbrush head vibrates causing the bristles to rotate. Because of this movement and speed, and as the toothbrush is moved over the surface of the teeth, the toothbrush scrubs and eliminates more plaque than a normal toothbrush would |
Comparator Agent |
Manual toothbrush |
To compare the effectiveness of three different types of toothbrushes on streptococcus mutans count. |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
1.Age group: 12 to 18.
2.Patients having at least 20 teeth which are either bonded/banded with fixed orthodontic appliance.
3.Have not taken any antibiotics since 1month.
4.Non smoker patients
|
|
ExclusionCriteria |
Details |
1.Patient with periodontal disease or loss of attachment.
2.Any systematic or local disease affecting the periodontium.
3.Using any chemical supplemental plaque control methods.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The aim of this study is to compare the effectiveness of Manual, electric and Ultrasonic Toothbrushes in fixed orthodontic treatment by quantifying the Streptococcus mutans bacteria in plaque. |
Clinical evaluations to be done at baseline and further at 1,3 and 6 months. |
|
Secondary Outcome
|
Outcome |
TimePoints |
The secondary aim of the study is to compare the efficacy of manual, electric and ultrasonic toothbrush in fixed orthodontic patients by comparing the changes in orthodontic plaque index and gingival index. |
Clinical evaluations to be done at baseline and further at 1,3 and 6 months. |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
N/A |
Date of First Enrollment (India)
|
26/07/2021 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Bacteria present in dental plaque are recognized as
the principal cause of caries and periodontal disease. Therefore, prevention
and treatment of these two diseases are mainly based on dental plaque removal.
Professional scaling and oral prophylaxis are the most effective methods to
reduce pathogenic organisms and also for plaque removal. However, personal oral
hygiene, using a toothbrush and dental floss daily, is very crucial for
satisfactory maintenance. Those patients who are undergoing orthodontic
treatment have greater difficulty in maintaining oral hygiene. Orthodontic
bands, brackets and wires are hindrances to brushing and flossing, frequently
facilitating accumulation of plaque to jeopardize gingival health. There
is a significant increase in Streptococcus mutans and lactobacilli after
the bonding of fixed appliances. Orthodontic treatment can increase
inflammation, bleeding, and enlargement of the gingiva as well as increasing
probing pocket depth.
Enamel demineralization after fixed orthodontic
therapy can occur in up to 50% of patients. Enamel demineralization is caused
by organic acids produced mainly by mutans streptococci (MS), which are known
to be the prime causative organism of dental caries. S mutans is the most frequently
isolated from human oral cavities and have been implicated as the main
causative organisms of dental caries.Extensive plaque accumulation
is associated with bonded orthodontic brackets , and a fixed appliance with
orthodontic brackets causes specific changes in the oral environment, such as
decreased pH and increased plaque accumulation.The bacterial
adhesion to orthodontic brackets can be the primary step leading to pathogenic
plaque formation and enamel demineralization around orthodontic brackets,
because the adhering bacteria continue to grow on the tooth surfaces near the
brackets. Therefore, information on the prevalence of S mutans in
orthodontic treatment is helpful for identifying patients at risk of developing
enamel demineralization and for planning caries-prevention programs during
orthodontic treatment.
Many clinical indices
,instrumental examinations ,and laboratory tests are available now a days in
order to study and define periodontal condition. Among them ,clinical indices
remain the most commonly used criteria for an ordinary evaluation, due to their
viability.Various indices used for gingival and periodontal health
evaluation are gingival bleeding index, plaque index, interdental pressure
index, papillary bleeding index and Ortho-plaque index.As
streptococcus mutans are considered as the main pathogens in initiation of
dental caries,the assessment
of plaque accumulation and prevalence of white spot lesions around the
brackets can be done by counting the colonies
of streptococcus mutans.
Various aids to
maintain oral hygiene in orthodontic treatment include manual toothbrushes,
dental floss, inter dental toothbrushes, three headed toothbrushes, powered
toothbrushes ,sonic and ultrasonic toothbrushes. Initially, manual toothbrushes
were commonly advised for the patients with orthodontic treatment. Because of
shortcomings of manual toothbrushes in plaque removal, powered
toothbrushes have been evaluated across a broad array of population groups and
study designs and have demonstrated similar or significantly greater plaque
removal compared with standard manual toothbrushes.
Among various types
of powered toothbrushes, existing evidence suggested that rotation-oscillation,
ionic, and ultrasonic brushes performed better than manual toothbrushes in
plaque reduction. They have been shown to remove significantly
greater in vitro Streptococcus mutans biofilm from
hydroxyapatite surfaces without bristle contacts compared with
rotation-oscillation toothbrushes.Home care
products to remove plaque, particularly in difficult-to access areas, is key to
improving patient compliance and avoiding disease. Beyond their clinically
proven efficacy in removing plaque, power toothbrushes can enhance patient
motivation, leading to increased tooth brushing frequency and duration. The use of
electric toothbrushes can offer better fluoride distribution throughout the
mouth .
The
first ultrasonic toothbrush was patented in USA in the year 1992 by
Robert T. Bock. Ultrasonic
toothbrushes mainly differ from conventional electrical toothbrushes in their higher
operating frequency (>20 kHz) .The used frequency range is not audible for
the human ear and may be beneï¬cial since hydrodynamic forces (such as flow rate
of the dental fluid and the formation of bubbles) are signiï¬cantly increased.
Still, the exact relation between the energy transfer from the brush to the
bioï¬lm and the contribution of acoustic waves to bioï¬lm removal remain unclear.The ultrasound moves the
bristles on the brush at a high speed and pressure. The toothbrush head vibrates
causing the bristles to rotate. Because of this movement and speed, and as the
toothbrush is moved over the surface of the teeth, the toothbrush scrubs and
eliminates more plaque than a normal toothbrush would. This means that they
move the brush head at such a rapid rate, that they are able to turbulently
move particles of water and air in a gentle and effective enough way to easily clean
between teeth and below the gum line. Ultrasound projected into the slurry
causes the expansion of the bubbles and contact lead to dislodgement of the
plaque bacteria adhering to the tooth surfaces Studies have even
shown that ultrasonic toothbrushes still provide superior plaque
removal even when they are held up to 4mm away from the tooth’s
surface. The handle of the brush is large enough to grip safely, and the head
of the device can be changed easily with simple instructions. The only
restriction for use is in patients with pacemakers because of the ultrasonic
transducer’s ability to adversely affect pacemaker function.
A number of studies showed that ultrasonic
toothbrushes could reduce more dental plaque but there is
insufficient data to show the streptococcus count in patients using different
types of brushes. Hence the present study is designed to compare the efficacy
of manual, electric and ultrasonic toothbrushes in the patients undergoing
fixed orthodontic treatment by quantifying streptococcus mutans in plaque in the Department of Orthodontics and Dentofacial Orthopaedics,Faculty of Dental Sciences,SGT University,Budhera ,Gurugram. |