| CTRI Number |
CTRI/2024/12/078282 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing occlusion when two types of metal crowns are fabricated and cemented on molars |
|
Scientific Title of Study
|
Assessment of occlusal force distribution using T-SCAN pre-operative and post-cementation of full metal crowns fabricated by conventional and direct metal laser sintered (DMLS) technique -A split-mouth randomized clinical 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 |
Mayuri Suresh Rajavadha |
| Designation |
PG student |
| Affiliation |
KLE VK Institute of dental sciences |
| Address |
Department number 3, Prosthodontics and crown and bridge, Ground floor, KAHERS KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi 590010, Karnataka, India Nehru Nagar Belgaum KARNATAKA 590010 India |
| Phone |
09503096519 |
| Fax |
|
| Email |
rajavadha.mayuri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Prashant Karni |
| Designation |
Reader |
| Affiliation |
KLE VK Institute of dental sciences |
| Address |
Department number 3, Prosthodontics and crown and bridge, Ground floor, KAHERS KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi 590010, Karnataka, India Nehru Nagar
KARNATAKA 590010 India |
| Phone |
9986497005 |
| Fax |
|
| Email |
prashantkarni@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Mayuri Suresh Rajavadha |
| Designation |
PG student |
| Affiliation |
KLE VK Institute of dental sciences |
| Address |
Department number 3, Prosthodontics and crown and bridge, Ground floor, KAHERS KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi 590010, Karnataka, India Nehru Nagar
KARNATAKA 590010 India |
| Phone |
09503096519 |
| Fax |
|
| Email |
rajavadha.mayuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics and crown and bridge, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi-590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr. Mayuri Rajavadha |
| Address |
Department of Prosthodontics and crown and bridge, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India |
| Type of Sponsor |
Other [(Self funded)] |
|
|
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 Mayuri Rajavadha |
KAHERs KLE VK Institute of dental sciences |
Department number 3, Ground floor, Prosthodontics and crown and bridge, KLE VK Institute of dental sciences, JNMC campus, Nehru nagar Belgaum KARNATAKA |
9503096519
rajavadha.mayuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE KVIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional metal crowns |
Molar crowns fabricated by conventional lost salt technique for 3 months |
| Intervention |
DMLS metal crowns |
Molar metal crowns fabricated by Direct Metal Laser Sintered technique for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who have undergone endodontic treatment in posterior teeth bilaterally, followed by post-obturation restoration in occlusion.
2) Teeth with one- or two-walled defects
3) Opposing teeth should have sound tooth structure without any restorations
|
|
| ExclusionCriteria |
| Details |
1) Patients are not willing to participate in the study.
2) Patients treated with post and core.
3) Teeth having more than 2 walled defects
4) Patients having para-functional habits like bruxism and TMDs
5) Patients having missing teeth adjacent and opposite to endodontically treated teeth.
6) Patients having periapical pathologies after RCT.
7) Patients having periodontally compromised teeth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the occlusal force distribution by using T-scan pre-operative and post-cementation of full metal crowns fabricated by conventional technique.
2) To assess the occlusal force distribution by using T-scan pre-operative and post-cementation of crowns fabricated by DMLS technique.
3) To evaluate and compare the occlusal force distribution by using T-scan pre-operative and post-cementation of crowns fabricated by conventional and DMLS techniques. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Patient comfort |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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 2 |
|
Date of First Enrollment (India)
|
11/01/2025 |
| 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 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
|
In patients who have undergone prosthetic rehabilitation with crowns and bridges, the distribution of occlusal forces may not be the same as before. Bite force evaluation helps to understand the mechanics of mastication, muscle activity during mastication, and the influence of physiological factors during the masticatory performance. These forces need to be evaluated and eliminated to achieve harmonious occlusal force distribution to protect the stomatognathic system. The prostheses fabricated by using conventional (lost wax technique) or DMLS technique are clinically acceptable. Comparative studies on the accuracy and precision of DMLS and conventionally fabricated crowns have been done. The studies have shown that a range of 0.4mm–2.8mm occlusal discrepancy is seen and is variable when posterior dental crowns are fabricated by conventional method or by DMLS method. The T-SCAN system records an accurate way of determining and evaluating the time sequence and force magnitude of occlusal contacts by converting qualitative data into quantitative parameters and displaying them digitally. Using this system, multiple corrections of occlusal discrepancies can be performed for every segment of the dentition. Comparative studies have been done to evaluate occlusal discrepancy by conventional methods, but the literature on T scans is sparse. Hence, the present study is undertaken to assess the occlusal force distribution by using T-scan pre-operative and post-cementation of metal crowns fabricated by conventional and DMLS techniques—a split-mouth randomized clinical study. |