| CTRI Number |
CTRI/2025/09/094877 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
EVALUATION OF ENAMEL SURFACE TOPOGRAPHY AFTER USING FOUR DIFFERENT FINISHING AND POLISHING SYSTEMS FOLLOWING ORTHODONTIC DEBONDING - A CLINICAL AND PROFILOMETRIC STUDY |
|
Scientific Title of Study
|
EVALUATION OF ENAMEL SURFACE TOPOGRAPHY AFTER USING FOUR DIFFERENT FINISHING AND POLISHING SYSTEMS FOLLOWING ORTHODONTIC DEBONDING - A CLINICAL AND PROFILOMETRIC 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 |
AMRUTHA VALLI MAMIDI |
| Designation |
PG STUDENT |
| Affiliation |
Drs. Sudha and Nageswararao Siddhartha Institute of Dental Sciences |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
ROOM NO. 7,
Drs. SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES.
Prakasam
ANDHRA PRADESH
521286
India |
| Phone |
886085710 |
| Fax |
|
| Email |
amruthamamidi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TANIKONDA RAMBABU |
| Designation |
HEAD OF DEAPARTMENT |
| Affiliation |
Drs. Sudha and Nageswararao Siddhartha Institute of Dental Sciences |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
ROOM NO. 7,
Drs. SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES.
Prakasam
ANDHRA PRADESH
521286
India |
| Phone |
9440364064 |
| Fax |
|
| Email |
amruthamamidi99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMRUTHA VALLI MAMIDI |
| Designation |
PG STUDENT |
| Affiliation |
Drs. Sudha and Nageswararao Siddhartha Institute of Dental Sciences |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
ROOM NO. 7,
Drs. SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES.
Prakasam
ANDHRA PRADESH
521286
India |
| Phone |
886085710 |
| Fax |
|
| Email |
amruthamamidi99@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMRUTHA VALLI MAMIDI,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
ROOM NO. 7,
Drs. SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES, CHINNAOUTPALLI, ANDHRA PRADESH, INDIA-521286 |
|
|
Primary Sponsor
|
| Name |
AMRUTHA VALLI MAMIDI |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
ROOM NO. 7,
Drs. SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES, CHINNAOUTPALLI, ANDHRA PRADESH, INDIA - 521286 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AMRUTHA VALLI MAMIDI |
ONGOLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| AMRUTHA VALLI MAMIDI |
Drs. SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
ROOM NO. 7,CHINNAOUTPALLI, 521286
Krishna
ANDHRA PRADESH |
886085710
amruthamamidi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drs. Sudha and Nageswararao siddhartha institute of dental sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ADJACENT NATURAL TOOTH ENAMEL SURFACE |
ADJACENT NATURAL TOOTH ENAMEL SURFACE IS COMPARED WITH THE INTERVENTION GROUP |
| Intervention |
DIFFERENT FINISHING AND POLISHING SYSTEMS |
FINISHING AND POLISHING OF SURFACE ROUGHNESS OF ORTHODONTICALLY TREATED TEETH AFTER THE COMPLETION OF THE ORTHODONTIC TREATMENT USING DIFFERENT POLISHING SYSTEMS |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Premolars that are indicated for orthodontic extraction will be considered.
Premolars with intact buccal surfaces.
|
|
| ExclusionCriteria |
| Details |
Carious tooth , restorations .
Tooth with visible fractures or enamel cracks.
Tooth with hypoplasia or other anomalies.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO RESTORE THE SURFACE OF ENAMEL AS CLOSELY AS POSSIBLE TO NATURAL TEETH |
AFTER COMPLETION OF ORTHODONTIC DEBONDING i.e, IMMEDIATELY AFTER THE TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SURFACE FINISHING AND POLISHING TO PREVENT SECONDARY CARIES |
IMMEDIATE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="1"
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
|
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Brief Summary
|
•Orthodontic bonding and deboning procedures involve risk of damaging the enamel surface and changing its original morphology . •The residual resin removal following orthodontic deboning further damages the enamel producing scratches, cracks , grooves , removal of fluoride rich external enamel layer. •The rough surface inhibits proper cleaning , invites plaque deposition , bacterial retention , and stain formation thus dampening the aesthetic appearance of the teeth. •Restoring enamel to its original form is a challenge. NEED FOR THE STUDY •There are several studies showing enamel surface roughness after finishing and polishing following orthodontic deboning . •There is limited literature available on checking enamel surface roughness using multiple finishing and polishing systems. •Hence ,this study is carried out to find the most acceptable finishing and polishing system both by patient and clinician. AIM •To Evaluate of enamel surface topography after using four different finishing and polishing systems following orthodontic debonding . SAMPLE SIZE 40
|