| CTRI Number |
CTRI/2024/05/067392 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare the accuracy and patient comfort of two impression techniques- Digital and conventional techniques in children having braces |
|
Scientific Title of Study
|
A Randomised crossover trial to compare the accuracy and patient comfort between conventional and digital impression techniques in children with multibracket appliance |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Nagesh |
| Designation |
Lecturer |
| Affiliation |
Saveetha Dental College |
| Address |
Saveetha dental college and hospitals, velappanchavadi, chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8870120723 |
| Fax |
|
| Email |
shwe14ta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Nagesh |
| Designation |
Lecturer |
| Affiliation |
Saveetha Dental College |
| Address |
Saveetha dental college and hospitals, velappanchavadi, chennai
TAMIL NADU
600077
India |
| Phone |
8870120723 |
| Fax |
|
| Email |
shwe14ta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Nagesh |
| Designation |
Lecturer |
| Affiliation |
Saveetha Dental College |
| Address |
Saveetha dental college and hospitals, velappanchavadi, chennai
TAMIL NADU
600077
India |
| Phone |
8870120723 |
| Fax |
|
| Email |
shwe14ta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveeth Dental College and Hospitals, Chennai |
|
|
Primary Sponsor
|
| Name |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Dental College and Hospitals, Velappanchavadi, Chennai |
| 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 |
| Dr Shweta Nagesh |
Saveetha Dental College and Hospitals |
Velappanchavadi, Chennai 600077
Chennai
TAMIL NADU |
8870120723
shwe14ta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Saveetha Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with dental malocclusion who are undergoing fixed braces treatment |
| Patients |
(1) ICD-10 Condition: K009||Disorder of tooth development, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional alginate based impression |
1. Alginate is an impression material used to record the anatomic details intraorally. It is commonly used in dentistry and is a gold standard for recording midtreatment record.
2. Maxillary and mandibular intral oral impression will be made using alginate with multibracket appliance once after placement of the orthodontic appliance.
3. Post making the impression, a cast will be made from the impression which will serve as a model of the maxillary and mandibular arches.
4. Patient comfort and experience will be recorded post the procedure.
5. The accuracy of the casts will be assessed |
| Comparator Agent |
Digital intra oral scan (Trios 4 optical scan) |
1. The digital scan will be used to record the maxillary and mandibular arch impressions.
2. The scan will be taken once as soon as the appliance is placed in the patients mouth.
3. The scan will record the maxillary and mandibular teeth and surrounding oral structures. It is routinely undertaken to assess the progress of orthodontic treatment as well as patient education regarding the treatment.
4. Based on the scan we will be assessing the patient comfort, time consumed chairside, any other discomforts associated with the procedure.
5. We will also be assessing the accuracy of the scan |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing orthodontic treatment with multibracket appliance.
2. All the tooth has been bonded
|
|
| ExclusionCriteria |
| Details |
1. Patients with craniofacial syndromes, pathologies and diseases
2. Multiple missing teeth and supernumerary teeth.
3. Sectional bracketing with any other orthodontic appliance placed in conjunction with routine fixed appliance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Digital and conventional impression techniques with respect to the pain, comfort, gag reflex and preference in young patients undergoing orthodontic treatment with multibracket appliance |
Baseline and after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the accuracy of the impression made using conventional and digital methods |
Baseline and after 1 week |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
27/05/2024 |
| 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="0"
Months="6"
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
|
Orthodontic treatment with fixed appliances is done to correct malocclusions. To assess the progress of treatment, mid stage records are made routinely. The records include photographs, radiographs, and models. The models are usually made using Alginate material impression. Due to advancement in 3D digital technology, intra oral scanners are now currently used in the market as it possesses several advantages over the conventional method of taking impression. There are previous studies that have compared the conventional and digital impression techniques, however without the appliance in the oral cavity. The effect of appliance in the oral cavity on the comfort of the impression technique has not been studied extensively. The current study is primarily aimed at comparing the patient comfort and preference between conventional method of taking impression versus digital technique in young children with orthodontic brackets. The study also aims to compare the accuracy of the models generated by the two techniques. |