| CTRI Number |
CTRI/2024/04/066432 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between Self etching primer and conventional acid etching technique with the effectiveness of pumice prophylaxis in orthodontic bonding |
|
Scientific Title of Study
|
A prospective RCT for the comparison between Self etching primer and conventional acid etching technique with the effectiveness of the pumice prophylaxis in orthodontic bonding. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshkumar Gandhi |
| Designation |
Postgraduate Resident |
| Affiliation |
Faculty of dental science, Dharmsinh Desai University |
| Address |
No.6, PG Division,Deparment of Orthodontics and Dentofacial Orthopedics, Faculty of dental science, Dharmsinh Desai University, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9104099335 |
| Fax |
|
| Email |
harshgandhi1108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Aakash Shah |
| Designation |
Professor, HOD, PG and PhD guide |
| Affiliation |
Faculty of dental science, Dharmsinh Desai University |
| Address |
No.6, PG Division,Department of Orthodontics and Dentofacial Orthopedics, Faculty of dental science, Dharmsinh Desai University, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9825373777 |
| Fax |
|
| Email |
aakash1172@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshkumar Gandhi |
| Designation |
Postgraduate Resident |
| Affiliation |
Faculty of dental science, Dharmsinh Desai University |
| Address |
No.6, PG Division, Deparment of Orthodontics and Dentofacial Orthopedics, Faculty of dental science,Dharmsinh Desai University, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9104099335 |
| Fax |
|
| Email |
harshgandhi1108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of dental science, Dharmsinh Desai University, Nadiad |
|
|
Primary Sponsor
|
| Name |
Harshkumar Gandhi |
| Address |
No.6, PG Division,Deparment of Orthodontics and Dentofacial Orthopedics, Faculty of dental science, Dharmsinh Desai University, NADIAD |
| 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 Harshkumar Gandhi |
Faculty of dental science, Dharmsinh Desai University |
No.6, PG Division, Deparment of Orthodontics and Dentofacial Orthopedics
Kheda
GUJARAT |
9104099335
harshgandhi1108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Faculty of Dental Science Dharmsinh Desai University |
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 |
| Intervention |
conventional acid etching technique with the use of pumice prophylaxis with use of Aster Prophy Pumice Prophylaxis paste, 3M ESPE scotchbondâ„¢ etchant, 3Mâ„¢ Transbondâ„¢ XT Light Cure Adhesive in Syringes kit |
The maxillary right segment teeth will be addressed. Before bonding, the labial/buccal surface of the incisors, canine, and premolars will be cleaned using a fluoride-free, oil-free Aster Prophy Pumice prophylaxis paste. It will then be washed with water and dried with compressed air .The mid-buccal enamel of each tooth will be etched for 15 to
30 seconds with a 37% 3M ESPE scotchbondâ„¢ etchant orthophosphoric acid gel applied by a sponge pledget. After rinsing with distilled abundant water spray and drying with oil-free compressed air to achieve a frosted enamel
appearance, Transbond XT primer will be applied to the etched surface. Transbond XT composite will then be applied to the bracket base, the bracket will be placed firmly in position, and excess composite will be removed prior to light curing about 40 seconds
|
| Comparator Agent |
conventional acid etching technique without the use of pumice prophylaxis use of 3M ESPE scotchbondâ„¢ etchant, 3Mâ„¢ Transbondâ„¢ XT Light Cure Adhesive in Syringes kit |
The maxillary left segment teeth will be addressed.The labial/buccal surface of the incisors, canine, and premolars will be etched for 15 to 30 seconds with a 37% 3M ESPE scotchbondâ„¢ etchant orthophosphoric acid gel applied by a sponge pledget. After rinsing with distilled abundant water spray and drying with oil-free compressed air to achieve a frosted enamel appearance, Transbond XT primer will be applied to the etched surface. Transbond XT composite will then be applied to the bracket base, the bracket will be placed firmly in position, and excess composite will be removed prior to light curing about 40 seconds. |
| Comparator Agent |
self etching primer with the use of pumice prophylaxis with use of Aster Prophy Pumice Prophylaxis paste, 3Mâ„¢ Self etching primer, 3Mâ„¢ Transbondâ„¢ XT Light Cure Adhesive in Syringes kit |
The mandibular left segment teeth will be addressed. Before bonding, the labial/buccal surface of the incisors, canine, and premolars will be cleaned using a fluoride-free, oil-free Aster Prophy Pumice prophylaxis paste. It will then be washed with water and dried with compressed air.The mid-buccal enamel of each teeth will be etch and prime in a single stage with 3Mâ„¢ Self etching primer by rubbing the enamel with the micro-brush applicator for 5 seconds and drying with oil-free compressed air then Transbond XT composite will then be applied to the bracket base, the bracket will be placed firmly in position, and excess composite will be removed prior to light curing about 40 seconds. |
| Comparator Agent |
self etching primer without the use of pumice prophylaxis with use of 3Mâ„¢ Self etching primer, 3Mâ„¢ Transbondâ„¢ XT Light Cure Adhesive in Syringes kit |
The mandibular right segment teeth will be addressed. The labial/buccal surface of the incisors, canine, and premolars will be etch and prime in a single stage with 3Mâ„¢ Self etching primer by rubbing the enamel with the micro-brush applicator for 5 seconds and drying with oil-free compressed air then Transbond XT composite will then be applied to the bracket base, the bracket will be placed firmly in position, and excess composite will be removed prior to light curing about 40 seconds. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with good oral hygiene.
Patients required fixed mechanotherapy therapy.
|
|
| ExclusionCriteria |
| Details |
Enamel hypoplasia and demineralization.
Fluorosis of teeth.
Teeth with restoration on labial/buccal surface.
Teeth with prosthesis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NUMBER OF BOND FAILURE |
6 months
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chairside time required |
After bonding |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study aims to
contribute more evidence-based research to the existing orthodontic literature.
The following conclusions can be drawn based on the findings of this clinical
investigation:
1. Conventional
acid etching with pumice prophylaxis (Group A1) exhibited the lowest bond
failure rate (5.0%) over the 9-month observation period and showed
statistically significant superiority (p = 0.015) in long-term bracket
retention compared to other groups, reaffirming its reliability as the gold
standard for bonding.
2. Self-etching
primers (SEP) significantly reduced chairside bonding time due to a simplified
application process. The shortest mean bonding time was observed in Group B2
(115.6 sec), while Group A1 took the longest (156.55 sec). These differences
were highly statistically significant (p < 0.001).
3. Pumice
prophylaxis significantly enhanced bond strength and reduced bond failure rates
in both conventional and SEP systems. The bond failure rate in Group B2 (SEP
without pumice) was 18.0%, which was significantly higher than in Group B1 (SEP
with pumice) at 8.0%, confirming that pumice use significantly improves enamel
preparation (p = 0.035 for B1 vs. B2).
4. Most
bracket failures occurred in the first 6 months, particularly in Group B2
(15.0%), and the chi-square analysis showed statistical significance at this
stage (p = 0.040). This highlights the critical role of precise bonding
technique and patient compliance in the early treatment phase.
5. While
SEP systems offer time efficiency, they may compromise bond
reliability—particularly without pumice. For consistent clinical success,
clinicians should strive for a balance between procedural efficiency and
long-term bond stability, using pumice prophylaxis with SEP when necessary, and
maintaining traditional CAE with pumice as the most dependable bonding
protocol.
|