| CTRI Number |
CTRI/2024/06/068906 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Examining pain experience and other dental and skeletal changes in patients affected with cleft disorder due to upper jaw expansion: A comparison Of two expansion devices |
|
Scientific Title of Study
|
Comparison and assessment of pain and dentoskeletal changes in cleft patients during rapid maxillary expansion - a randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedha R |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
II nd year Postgraduate
Department of Orthodontics and Dentofacial Orthopedics, Sri Ramachandra Dental College, Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai -116
Chennai
TAMIL NADU
600116
India |
| Phone |
9551456575 |
| Fax |
|
| Email |
19nivedha98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Siva Subramanian |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics. Faculty of dental sciences, Sri Ramachandra University, Porur, Chennai, Tamil Nadu, India - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840025621 |
| Fax |
|
| Email |
sivasubramanian.c@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Siva Subramanian |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics. Faculty of dental sciences, Sri Ramachandra University, Porur, Chennai, Tamil Nadu, India - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840025621 |
| Fax |
|
| Email |
sivasubramanian.c@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Post Graduate Resident Stipend Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Resident Stipend |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116 |
| 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 Nivedha R |
Sri Ramachandra Faculty of Dental Sciences |
Sri Ramachandra
Institute of Higher
Education and Research, Department of Orthodontics and Dentofacial Orthopedics, room no 9, No.1,
Ramachandra Nagar,
Porur, Chennai -
600116
Chennai
TAMIL NADU |
9551456575
19nivedha98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fan-type maxillary expansion device |
Patients with unilateral cleft who will undergo maxillary expansion with fan-type expander will be involved in this group pre-expansion and post-expansion (after 2 weeks of expansion) lateral cephalograms and posteroanterior cephalograms, and gingival crevicular fluid (GCF) sample is taken from them. The levels of prostaglandin E2 in GCF, the Visual Analog Scale (VAS) scores and the dentoskeletal effects will be evaluated |
| Intervention |
hyrax maxillary expansion device |
Patients with unilateral cleft who will undergo maxillary expansion with hyrax expander will be involved in this group pre-expansion and post-expansion (after 2 weeks of expansion) lateral cephalograms and posteroanterior cephalograms, and gingival crevicular fluid (GCF) sample is taken from them. The levels of prostaglandin E2 in GCF, the Visual Analog Scale (VAS) scores and the dentoskeletal effects will be evaluated |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with non-syndromic cleft lip and palate
2.Patients with unilateral cleft.
3.Patients undergoing orthodontic treatment with rapid maxillary expansion.
4.Patient of both genders within the age group of 10 yrs - 15 yrs.
• No history of previous orthodontic treatment
|
|
| ExclusionCriteria |
| Details |
1.Smokers/ Individual with pan chewing habit
2.Patients with any systematic conditions
3.History of antibiotic or anti-inflammatory drug therapy in the past 7 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the Predesignating (PGE2) expression and VAS score
|
1 hour before insertion of expander: baseline (T0);
day 1 - 15minutes after activation of expander (T1); day 4 - 15minutes after activation of expander (T2); day 7 - 15minutes after activation of expander (T3).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 4. To measure the dentoskeletal effects in hyrax expander group & fan-type expander group |
pre-expansion radiographs (baseline)
post-expansion radiographs (2 weeks) |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Cleft lip and palate (CLP) is a common
craniofacial defect that affects about one in every 800 births.1 The treatment of
patients affected by cleft lip and palate (CLP) presents many challenges in multi-disciplinary
management. Orthodontic treatment is often required over many
years for any
midface deficiencies.
As a consequence,
the growth and development of the maxillary segments are compromised by scar
tissues, thus inducing maxillary constriction, particularly in the anterior
region. Rapid maxillary expansion (RME) is commonly used to correct this
transverse deficiency.
2,3 Often, the goal of Rapid maxillary
expansion (RME) for many cleft patients has been to increase the anterior
maxillary expansion and restrain the posterior expansion, since there is a
greater anterior than posterior maxillary constriction in most of these
patients. 4,5
Pain and discomfort
are some of the most common side effects reported by the patients after RME
screw activation6 . There are studies evaluating pain during maxillary expansion using
different scales, but none of the studies done previously have evaluated the
pain during rapid maxillary expansion in unilateral cleft patients by assessing PGE2 during different intervals between hyrax expander and fan-type expander. The rationale for conducting this study is to
assess the pain intensity with hyrax expander and fan-type expanderâ— Patients
were divided into 2 groups-
â— Group
1: Patients with unilateral cleft who will undergo maxillary expansion with
hyrax expander will be involved in this group pre-expansion and post-expansion
(after 2 weeks of expansion) lateral cephalograms and posteroanterior
cephalograms, and gingival crevicular fluid (GCF) sample is taken from them.
The levels of prostaglandin E2 in GCF, the Visual Analog Scale
(VAS) scores and the dentoskeletal effects will be evaluated.
â—
Group 2: Patients with
unilateral cleft who will undergo maxillary expansion with fan-type expander
will be involved in this group pre-expansion and post-expansion (after 2 weeks
of expansion) lateral cephalograms and posteroanterior cephalograms, and
gingival crevicular fluid (GCF) sample is taken from them. The levels of
prostaglandin E2 in GCF, the Visual
Analog Scale (VAS) scores and the dentoskeletal
effects will be evaluated
â—
After the intervention is
given, the levels of prostaglandin E2 in GCF, the Visual Analog Scale
(VAS) scores and the dentoskeletal effects will be evaluated and compared
between the hyrax
expander group and fan-type expander group
|