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CTRI Number  CTRI/2025/03/083263 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 07/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing lip closing strength in different skeletal teeth arrangement with different growth patterns 
Scientific Title of Study   Comparative Evaluation of Lip Closing Strength In Various Skeletal Malocclusions with different Growth Patterns :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  Monika Singla 
Designation  Post Graduate student 
Affiliation  Rajasthan university of health sciences 
Address  surendera dental college and research institute,sriganganagar rajasthan 335001 india
HH gardens,power house road sriganganagar
Ganganagar
RAJASTHAN
335001
India 
Phone  9462428749  
Fax    
Email  monikaortho2024@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Eenal Bhambri 
Designation  professor and head 
Affiliation  Rajasthan university of health sciences 
Address  surendera dental college and research institute,HH gardens,power house road,sgnr
department of orthodontics and dentofacial orthopaedics,room number 3,surendera dental college and research institute,HH gardend,power house road,sriganganagar
Ganganagar
RAJASTHAN
335001
India 
Phone  8769829700  
Fax    
Email  dreenal700@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Monika Singla 
Designation  post graduate student 
Affiliation  Rajasthan university of health sciences 
Address  department of orthodontics and dentofacial orthopaedics,room no 3,
surendera dental college and research institute,HHgardens ,power house road,ganganagar
Ganganagar
RAJASTHAN
335001
India 
Phone  9462428749  
Fax    
Email  monikaortho2024@gmail.com  
 
Source of Monetary or Material Support  
Department of orthodontics and dentofacial orthopeadics,Room number 3,A block,surendera dental college and research institute,sriganganagar,rajasthan,335001 
 
Primary Sponsor  
Name  Monika Singla 
Address  surendera dental college and research institute,sriganganagr,rajasthan,335001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Monika Singla  surendera dental college and research institute,sriganganagar  Depatment of orthodontics and dentofacial orthopaeidcs,room number 3,surendera dental college and research institute,HH gardens,power houser road,ganganagar,335001,india
Ganganagar
RAJASTHAN 
09462428749

monikaortho2024@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE SURENDERA DENTAL COLLEGE AND RESEARCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  skeletal CLASS 1 , CLASS 2, CLASS 3 malocclusion  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  patient with no history on long term medical usage,with healthy oral dental tissues,no history of previous orthodontic treatment,fall underrespected groups divided on the basis of cephalometric measurement 
 
ExclusionCriteria 
Details  patient taking any medication,patient with open bite any any other systemic disorder 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare lip closing strength of force in patients with various skeletal malocclusions with different growth patterns in males and females at rest and during swallowing  5 mintues 
 
Secondary Outcome  
Outcome  TimePoints 
To corelate the amount of lip force with different maolocclusions   5 mintues 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   27/06/2025 
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="2"
Months="0"
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  

 

Profile esthetics is generally becoming one of the major objectives of patients seeking orthodontic or orthognathic therapies nowadays. The lip is the pivotal feature affecting the esthetics of the lower third of face, especially as upper lip attracts the greatest attention.

The main function of the lips, ie, oral competence, is controlled by Orbicularis oris muscle1 and the mentalis muscle. In cases like  bimaxillary protrusion or severe class II div 1, lip incompetence often results in  hypertrophic muscle activity as subjects unconsciously exert effort to keep their lips closed at rest. Apart from this muscle activity, Profit found that the resting lips also have a possible influence on the dentition2. Tomes almost 100 years ago advanced a theory that it is the perioral musculature and lips and tongue that principally determine the position of teeth1. The balance of these muscles is very important in the growth and development of craniofacial region and also credited in post treatment retention and stability. So, as an Orthodontist, it is important to measure the perioral muscle force but since pressure measurement is more difficult than strength, so force or strength measurement is preferable.

It is hypothesized that this perioral muscle force will vary between different malocclusions. So, various studies have been conducted to relate the effect of lip force on craniofacial growth  but with conflicting results.

Posen conducted a study to measure the strength of lips in subjects with Angle Class II div 2 and subjects with bimaxillary protrusion and found that the subjects with class II divison 2 had high lip strength and subjects with bimaxillary protrusion had low lip strength3.

Ingervall and Theur  investigated the relationship between lip strength, bite and facial morphology and concluded that lip strength was small in children  with  large overjet , long dental arches, proclined incisors or Angle Class II malocclusion and children with large interlabial gap4.

 

 

Ingervall and Janson Profit et al5 concluded that subjects with hypodivergent growth pattern have greater development of their perioral and masticatory musculature than the hyperdivergent growth pattern but Jung1 and Hodge et al found no significant correlation between horizontal skeletal pattern and the upper lip closing force in their studies1.

Lambrechts et al6 investigated  any difference in lip pressure on the basis of gender, Angle classification and characteristics of malocclusion and concluded that lip pressure was higher in males subjects than females  and higher  lip pressure in  class I malocclusion than class II div 1 malocclusion subjects.

Due to controversial results and none of the study on class III malocclusion, the research in various craniofacial patterns remains unclear.

Many methods have been introduced to measure force or pressure put by lips in oral cavity like Pommeter consisting of a mouthpiece connected to a dynamometer, Electomyography , Y-meter  ,  force sensing resistor device ( flexiforce low type) ,  Myometer160, bulb filled with some fluid and Oral Performance Instrument . However ,they all have one or the other drawbacks like the flexiform sensors are too costly and fragile and also produce errors when used for long time.The dynamometers are less sensitive.IOPI is also not affordable.The air filled bulbs have problem in positioning and reproductiblity within oral cavity.

So, in this,  study a MD30-60 SENSOR will be used to measure the vertical vector of lip closing force. It is cost effective, simple and easy to integrate, ultra thin, durable and delivers stable performance over time, waterproof, pressure sensitive for versatile applications.

To the best of my knowledge,none of the study has evaluated lip  force in various skeletal malocclusions with different growth patterns. So, the aim of this  study is to evaluate and compare lip closing strength in various skeletal malocclusions with different growth patterns in males and females and lip strength at rest and during swallowing.

 

 

 

 
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