| CTRI Number |
CTRI/2024/01/061487 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare number of oral bacterial colonies and salivary pH in patients treated with removable orthodontic appliance to correct lower jaw deficiency |
|
Scientific Title of Study
|
Comparison and evaluation of oral streptococcus mutans count and salivary pH in patients treated with removable twin block appliance - an in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chirag Goel |
| Designation |
MDS III YEAR |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Orthodontics, Bapuji Dental College and Hospital, MCC B Block, Davangere, Karnataka
Davanagere
KARNATAKA
577004
India |
| Phone |
8130789875 |
| Fax |
|
| Email |
chiraggoel29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Kumar H C |
| Designation |
Head of Department and Professor |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Orthodontics, Bapuji Dental College and Hospital, MCC B Block, Davangere, Karnataka
Davanagere
KARNATAKA
577004
India |
| Phone |
9886040122 |
| Fax |
|
| Email |
kiranortho77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chirag Goel |
| Designation |
MDS III YEAR |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Orthodontics, Bapuji Dental College and Hospital, MCC B Block, Davangere, Karnataka
Davanagere
KARNATAKA
577004
India |
| Phone |
8130789875 |
| Fax |
|
| Email |
chiraggoel29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Department of Oral pathology, Bapuji Dental College and Hospital, MCC B Block Davangere, Karnataka, 577004 |
|
Primary Sponsor
Modification(s)
|
| Name |
Chirag Goel |
| Address |
Department of Orthodontics, Bapuji Dental College and Hospital, MCC B Block, Davangere, Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 Chirag Goel |
Bapuji Dental College and Hospital |
Room no. 4, Department of Orthodontics and Dentofacial Orthopaedics
Davanagere
KARNATAKA |
8130789875
chiraggoel29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Bapuji Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Class I malocclusion |
volunteers who do not require any immediate line of treatment from any functional or fixed type of orthodontic mechanotherapy having angles class I type of malocclusion |
| Intervention |
Removable twin block |
it is a type of functional appliance used to bring growth modulation of mandible in Angles class II malocclusion with retruded mandible cases by posturing the mandible forward. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are prescribed functional orthodontic therapy using removable twin block
appliance.
Fewer than 5 decayed, missing, or filled teeth. |
|
| ExclusionCriteria |
| Details |
Patients treated with fixed orthodontics
Patients having any systemic disease.
Patients on any antimicrobial therapy in the past 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| salivary streptococcus mutans colony count |
At the delivery of appliance, one month and 6 months after the delivery of appliance. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| salivary ph |
at the delivery of appliance, one month & 6 months after the delivery of appliance. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
20/01/2024 |
| Date of Study Completion (India) |
15/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under Process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
ABSTRACT
BACKGROUND AND
OBJECTIVES:
Oral
microbiome is a diverse ecosystem of various microorganisms, and orthodontic
treatment can make its maintenance challenging. Streptococcus mutans
being a primary bacterium responsible for caries, during orthodontic treatment
its count can increase upto 5 folds. Twin block appliance consists of simple
maxillary and mandibular bite blocks which interlock at 70 degrees angle to
provide correction of skeletal Class II malocclusions with mandibular
retrognathism.
The
objective of this study was to evaluate the change in the oral Streptococcus
mutans colony count after the initiation of orthopedic treatment using
removable twin block appliance in the mixed dentition phase and correlate it
with the salivary pH.
METHOD:
In
this study, unstimulated saliva was collected following the delivery of
orthopedic appliance, 1 month and 6 months after the delivery of removable twin
block appliance and salivary pH was measured. Streptococcus mutans
colonies were cultured and counted. Inter-group comparison was done using
Mann-Whitney U test and Chi-square test and Intra-group comparison was done
using Friedmans ANOVA. Pearson’s correlation was used to identify correlation
between bacterial colonies and salivary pH. The significance level is set at P
< 0.05.
RESULTS:
The findings showed statistically significant
increase in the number of Streptococcus mutans colonies from T0-T1, T1-T6
and salivary pH from T0-T1, T1-T6 in removable twin block group.
There was no statistically significant increase present in the number of Streptococcus
mutans colonies and salivary pH in the control group. The results also
showed a positive correlation between Streptococcus mutans and salivary
pH only at T0 for removable twin block group and at T6 for control group.
CONCLUSION:
The
study concludes that there is an increase in the colony count in oral cavity
after a removable twin block is delivered in patients to correct skeletal
malocclusions but is statistically not significant when compared to untreated
controls.
KEY WORDS:
Streptococcus
mutans, Class II, Removable Twin Block, Salivary pH, In-Vivo study.
|