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CTRI Number  CTRI/2019/01/017137 [Registered on: 17/01/2019] Trial Registered Prospectively
Last Modified On: 28/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Upper jaw expansion with mini-implants with or without tiny bone holes 
Scientific Title of Study   Comparative Evaluation of Maxillary Skeletal Expansion using Mini-implant Assisted Rapid Palatal Expander with and without Micro osteoperforation in the Mid Palatal Suture region: A Randomized Clinical Trial. 
Trial Acronym  MARPE AND MOP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MADHURA JAYANT PEDNEKAR 
Designation  FIRST YEAR POST GRADUATE STUDENT 
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS POST GRADUATE DIVISION FLOOR 6 MGM DENTAL COLLEGE AND HOSPITAL junction of nh4 and sion panvel expressway sector 1 kamothe navi mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9920744907  
Fax    
Email  mjpednekar22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek J Patni 
Designation  READER, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS 
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS POST GRADUATE DIVISION FLOOR 6 MGM DENTAL COLLEGE AND HOSPITAL junction of nh4 and sion panvel expressway sector 1 kamothe navi mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9324087948  
Fax    
Email  drvivekpatni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MADHURA JAYANT PEDNEKAR 
Designation  FIRST YEAR POST GRADUATE STUDENT 
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS POST GRADUATE DIVISION FLOOR 6 MGM DENTAL COLLEGE AND HOSPITAL junction of nh4 and sion panvel expressway sector 1 kamothe navi mumbai

Raigarh
MAHARASHTRA
410209
India 
Phone  9920744907  
Fax    
Email  mjpednekar22@gmail.com  
 
Source of Monetary or Material Support  
MGM DENTAL COLLEGE AND HOSPITAL junction of nh4 and sion panvel expressway sector 1 kamothe navi mumbai maharashtra Raigarh MAHARASHTRA 
 
Primary Sponsor  
Name  DR MADHURA JAYANT PEDNEKAR 
Address  L 602 SHELL TOWERS CHS SHELL COLONY SAHAKAR NAGAR 1 CHEMBUR MUMBAI 400071 
Type of Sponsor  Other [SELF] 
 
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 MADHURA JAYANT PEDNEKAR  MGM DENTAL COLLEGE AND HOSPITAL  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS POST GRADUATE DIVISION FLOOR 6 junction of nh4 and sion panvel expressway sector 1 kamothe navi mumbai
Raigarh
MAHARASHTRA 
9920744907

mjpednekar22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL REVIEW COMMITTEE MAHATMA GANDHI MISSIONS DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R930||Abnormal findings on diagnostic imaging of skull and head, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mini-implant Assisted Rapid Palatal Expander with Micro osteoperforation  MICRO OSTEOPERFORATION IN MID PALATAL SUTURE REGION 6 MM AWAY FROM INCISIVE PAPILLA REGION FOLLOWED BY EXPANDER ANCHORED WITH 4 MINI-IMPLANTS TO THE PALATE 
Comparator Agent  MINI-IMPLANT ASSISTED RAPID PALATAL EXPANDER WITHOUT MICRO OSTEOPERFORATION  EXPANDER ANCHORED WITH 4 MINI-IMPLANTS TO THE PALATE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1) Subjects in the age group of 18 to 40 years of either gender indicated for skeletal
maxillary expansion.
2) Subjects with good oral hygiene.
3) Subjects with healthy periodontal tissues.
4) Subjects with no prior history of orthodontic treatment and/ or orthognathic
surgery.
5) Subjects with no severe dentofacial anomalies or syndromic conditions.
6) Subject with no radiographic evidence of bone loss.
7) Subject with no systemic disease or conditions. 
 
ExclusionCriteria 
Details  Subjects other than the age group of 18 to 40 years.
2) Subjects without good oral hygiene.
3) Subjects with compromised periodontal tissues.
4) Subjects with prior history of orthodontic treatment and/ or orthognathic
surgery.
5) Subjects with severe dentofacial anomalies or syndromic conditions.
6) Subject with radiographic evidence of bone loss.
7) Subject with systemic disease or conditions.
8) Subject with long term use of medications e.g. Antibiotics, phenytoin,
cyclosporine, anti-inflammatory drugs, systemic corticosteroids, bisphosphonates. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
MAXILLARY SKELETAL EXPANSION WITH MINIMAL DENTAL SIDE EFFECTS  TWO MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
LEESER ROOT RESORPTION, LESSER BUCCAL TIPPING, LESSER CHANCES OF BUCCAL BONY FENESTRATION AND DEHISCENCE OF ANCHOR TEETH  TWO MONTHS 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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 1 
Date of First Enrollment (India)   25/06/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
Mini-implants are successfully used with palatal expanders to work as anchors
and to achieve more efficient skeletal expansion while decreasing undesired dental
effects. Mini-implant Assisted Rapid Palatal Expander (MARPE) shows distribution of
stress throughout the palate while preventing unwanted rotation and tipping of the
maxillary anchor teeth.
Most patients prefer a short orthodontic treatment time. Over the past decade,
the Regional Acceleratory Phenomenon (RAP) induced by surgical trauma has thus
gained emphasis for reducing orthodontic treatment time. This has lead to the
evolution of minimally invasive surgical procedures for inducing RAP for eg. micro
osteoperforation, low level laser therapy etc.
Treixeira et al. have shown that biological principles can be activated to accelerate bone
remodelling using Micro osteoperforation (MOP). In MOP, minute perforations are
created within the bone. Micro osteoperforation increases local levels of inflammatory
cytokine activity around a tooth, which increases bone remodelling by stimulating
osteoclastic activity and causing transient osteopenia. Micro osteoperforation yields
very little discomfort to the patient, can be performed chair side in a few minutes and
can be used in conjunction with any treatment modality including TADs, aligners, etc.
There are sporadic suggestions that MOP can be used in cases where palatal split is not
occurring within first few days of expander activation.
Thus, in this proposed study, we are performing micro osteoperforation, a
minimally invasive technique of accelerated orthodontics in the mid palatal suture
region for Rapid Maxillary Expansion (RME) using mini–implants for skeletal anchorage.
The study intends to compare efficacy of rapid maxillary expansion using mini–implants
with MARPE done with and without MOP. The rationale of this study is that it would
guide clinicians to select the appropriate treatment protocol and achieve optimum
results for their patients
 
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