| CTRI Number |
CTRI/2024/03/064287 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative assessment of clinical usefulness of 2 proximal finishing systems |
|
Scientific Title of Study
|
Clinical Evaluation Of Two Proximal Contour Finishing Systems. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSusila Anand |
| Designation |
HOD |
| Affiliation |
Madha Dental College |
| Address |
Room number 5
Department of conservative dentistry and endodontics
Madha dental college , madha nagar , kundrathur, chennai
Kancheepuram TAMIL NADU 600069 India |
| Phone |
7273901234 |
| Fax |
|
| Email |
drsusila2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrSusila Anand |
| Designation |
HOD |
| Affiliation |
Madha Dental College |
| Address |
room number 5
Department of conservative dentistry and endodontics
Madha dental college , madha nagar , kundrathur, chennai
TAMIL NADU 600069 India |
| Phone |
7273901234 |
| Fax |
|
| Email |
drsusila2000@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
R, Loshini |
| Designation |
PG student |
| Affiliation |
Madha Dental College |
| Address |
Room number 5
Department of conservative dentistry and endodontics
Madha dental college , madha nagar , kundrathur, chennai
Chennai TAMIL NADU 600069 India |
| Phone |
7273901234 |
| Fax |
|
| Email |
loshiniraj20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrLoshini |
| Address |
Room number 5
Department of conservative dentistry and endodontics
Madha Dental College
Chennai |
| 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 V Susila Anand |
Madha Dental College |
Room number 5
Department of conservative dentistry and endodontics
Madha Nagar, kundrathur, chennai 600069 Kancheepuram TAMIL NADU |
7273901234
drsusila2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madha Dental College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finishing and polishing
Sofu Supersnap Rainbow kit |
15 minutes
the Shofu discs were used according to the color coded grits (Black – Coarse; Violet – Medium; Green – Fine; Red – Superfine) to achieve a polished and contoured interproximal surface using a low speed contra angle handpiece. Patients are evaluated on the day of restoration and 10 days follow- up |
| Comparator Agent |
finishing polishing
Profin system and Shofu |
Profin reciprocating system has smooth, glare-free surface, and a miniature head for best access into incapacious areas. The oscillating, controlled impact movement of the inserts can carefully, precisely, and safely grind, finish, and polish natural dentition and all types of restoration materials. The Profin instrument was used with a series of Lamineer diamond-coated metal tips which are Safe-sided to prevent damage to adjacent tissue or enamel. Its is used in the abrasive order over the proximal areas to attain proper polished surface. The Patients are evaluated on the day of restoration and 10 days follow up. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Any proximal restoration of vital and non-vital teeth.
2.Age group – 15 to 70 years
3.Gender – Male and Female
4.Supragingival caries
5.Permanent dentition
|
|
| ExclusionCriteria |
| Details |
1.Unerupted or partially erupted teeth
2.Patients with bruxism habit
3.Teeth with Diseased pulp
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| finishing and polishing system for proximal composite restoration |
Baseline, 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| finishing & polishing system for proximal composite restoration |
10 days |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="8" Days="30" |
|
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
|
The key to aesthetics and bio-integration of
composite restorations lies in the final step of finishing and polishing. To
achieve a successful restoration, it is important to maintain a smooth surface.
Ideal finishing and polishing of restorations improves aesthetics and maintains
the oral health of a patient. A rough surface serves as a site for bacterial
adhesion, accumulates plaque, causes irritation to the gingiva, and results in
periodontal diseases. Increased microleakage can cause staining at restoration
margins, sensitivity, and secondary caries formation. Therefore finishing and
polishing plays an important role in clinical restorative procedure. This procedure
involves a sequential use of instruments with a progressive decrease in
abrasiveness to achieve a highly smooth surface. Profin reciprocating system is
specially designed for polishing proximal restorations. It has tactile ergonomics, smooth,
glare-free surface, and a miniature head for best access into incapacious
areas. The oscillating, controlled impact movement of the inserts can
carefully, precisely, and safely grind, finish, and polish natural dentition and
all types of restoration materials. The other group is Shofu Supersnap Rainbow Technique
Kit is designed for finishing of all surfaces which can be adapted to finish
the proximal surface. This study is evaluated using modified RYDGE criteria on
the day of restoration and 10 days followup.
|