| CTRI Number |
CTRI/2025/06/089211 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Ways to Reduce Pain When Removing Braces. |
|
Scientific Title of Study
|
Assessment of the efficacy of different pain management methods in orthodontic debonding: 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 |
Dr Shaik Farhatulla |
| Designation |
Postgraduate Student |
| Affiliation |
GSL DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9849492909 |
| Fax |
|
| Email |
shaikfarhat79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranganayakulu Inuganti |
| Designation |
Reader |
| Affiliation |
GSL DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296
Department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9959434440 |
| Fax |
|
| Email |
expertdentalcare1104@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranganayakulu Inuganti |
| Designation |
Reader |
| Affiliation |
GSL DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
09959434440 |
| Fax |
|
| Email |
expertdentalcare1104@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthodontics and dentofacial orthopedics, room no 9, GSL Dental College and Hospital, Lakshmipuram, Rajahmundry, 533296 |
|
|
Primary Sponsor
|
| Name |
Dr. Shaik Farhatulla |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, lakshmipuram, rajahmundry. 533296 |
| 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 Shaik Farhatulla |
GSL DENTAL COLLEGE AND HOSPITAL |
Department of orthodontics and dentofacial orthopedics, room no 9, GSL dental college and hospital, Lakshmipuram, Rajahmundry, Andhra pradesh. 533296
East Godavari
ANDHRA PRADESH |
9849492909
shaikfarhat79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
finger pressure |
During debonding of each
bracket, the finger pressure of the operator will be
applied in the gingival direction with the thumb on the
incisal or occlusal surface of the tooth. |
| Intervention |
vibration anesthetic device, Stress relief, Elastomeric wafer |
1.vibartion anesthetic device- started 5 sec prior to procedure
2.stress relief- explained 30 min prior to procedure
3. elastomeric wafer- placed 10 min prior to procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 and above years who could understand, assess and answer the questionnaires
2. Undergoing treatment of both arches
3. Finishing arch wires present for at least two months prior
to debonding |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of taking medicine periodically or in the last 24 hr
2.Patients with anxiety score of more than 8 according to GAD 7 scoring
3. Debonded brackets at the time of debonding
4. Missing teeth except for extracted premolars
5. Active periodontal problems
6. Heavily restored or root canal treated tooth
7. Craniofacial deformities that would affect the
dentoalveolar bone quality
8. Surgical treatment including impacted tooth removal |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| level of pain VAS Score |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
duration of debonding procedure
anxiety levels |
6 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/06/2025 |
| 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="0"
Months="6"
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
|
PRIMARY PURPOSE OF THE STUDY: To evaluate and compare the effectiveness of different pain management methods like finger pressure, stress relief, vibration anesthesia and elastomeric wafer in reducing pain during orthodontic debonding using visual analogue scale.
STUDY HYPOTHESIS:
Null Hypothesis: there is no significant difference in pain perception during orthodontic debonding among four pain management methods.
alternative hypothesis: there is a significant difference in pain perception during orthodontic debonding among the four pain management methods, with at least one method being more effective in reducing pain than the others. |