| CTRI Number |
CTRI/2020/09/027648 [Registered on: 08/09/2020] Trial Registered Prospectively |
| Last Modified On: |
26/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of cavities filled with preheated composites and ultrasonically plasticized composites |
|
Scientific Title of Study
|
‘Clinical Behaviour Of Composite Resin restoration Plasticized With Different techniques |
| Trial Acronym |
.. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Girija S Sajjan |
| Designation |
HOD and Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College
Vishnupur ,Bhimavaram West Godavari ANDHRA PRADESH 534202 India |
| Phone |
8179846088 |
| Fax |
|
| Email |
girijaendo@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sindhu Dutta |
| Designation |
Post Graduate |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College
Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India |
| Phone |
7989811611 |
| Fax |
|
| Email |
sindhudutta1995@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sindhu Dutta |
| Designation |
Post Graduate |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College
Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India |
| Phone |
7989811611 |
| Fax |
|
| Email |
sindhudutta1995@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vishnu Dental College |
| Address |
Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari, -534202 |
| 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 |
| Sindhu Dutta |
Vishnu Dental College |
Department of Conservative Dentistry and Endodontics, Room no -4 Block III vishnu dental college
vishnupur ,bhimavaram
Andhrapradesh -534202 West Godavari ANDHRA PRADESH |
7989811611
sindhudutta1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Preheated composite resin |
Composite resin will be peheated for 5 mins at 60 degree celcius and will be placed into the cavities. |
| Intervention |
Ultrasonically plasticized composite resin |
composite resin will be placed into the cavities and will be plasticized using ultrasonic tips for 5 minutes at power level of 7. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient is older than 18 years and younger than 40 years.
The presence of teeth to be restored in occlusion;
Teeth that were symptomless and vital;
A normal periodontal status;
Medium size cavities size of the isthmus with no more than two thirds of the intercuspal distance and the gingival margin of the cavities above the cementoenamel junction.
A good likelihood of recall availability |
|
| ExclusionCriteria |
| Details |
Xerostomia and bruxism
Absence of adjacent and antagonist teeth
Extremely poor oral hygiene, severe or chronic periodontitis
Adverse medical history
Potential behavioural problems. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will there be difference in clinical outcome in restorations placed by preheating composite and ultrasonic plasticization of composite. |
Baseline and One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
05/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
submitted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sindhudutta1995@gmail.com].
- For how long will this data be available start date provided 24-06-2021 and end date provided 26-06-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Good marginal adaptation is the key for successful composite resin restorations as it can reduce microleakage. In the pursuit of improving the strength of composite resin, more fillers are incorporated. The resulting increased viscosity of the material might lead to compromised adaptation to the cavity. This along with polymerization shrinkage may lead to compromised clinical performance. Hence the reduction in viscosity of these materials may improve the marginal adaptation and clinical performance. Preheating of composite resin reduces viscosity and increases flowability, which facilitates better adaptation to cavity walls. The problem here is once composite is pre-heated; there is a time delay between dispensing it from a syringe, placing it into preparation, and subsequently light polymerizing it. It is estimated that when a composite is heated up to 60 â—¦C and removed from the device, the temperature reduces 50% after 2min and 90% after 5min. The problem associated here is their limited literature on the clinical use of preheated composite. Another recent introduction of sonic fill (kerr corp. USA) combines the attributes of a low viscosity composite and a universal composite. By plasticizing composite with sonic energy, it is possible to fill the cavity and adapt the low viscosity material easily and then compact it while composite changes its consistency until it reaches a higher viscosity. But it is not recommended due to the high cost and unavailability in India. By simulating this concept, it was thought that conventional ultrasonic tips may be used for generating ultrasonic vibrations and possible to alter the consistency of high viscosity material to a consistency that can be compacted and made to adapt to cavity walls. |