| CTRI Number |
CTRI/2023/11/059597 [Registered on: 07/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of occlusion on tooth strain |
|
Scientific Title of Study
|
Effect of occlusion on tooth strain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Sai Saranya Koya |
| Designation |
MDS Postgraduate |
| Affiliation |
Thaimoogambigai Dental College and Hospital |
| Address |
Department of conservative dentistry and Endodontics, Thaimoogambigai Dental College and Hospital, golden george nagar, Mogappair, Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
9966300849 |
| Fax |
|
| Email |
ksaisaranya36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A R Pradeep Kumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Thaimoogambigai Dental College and Hospital |
| Address |
Department of conservative dentistry and Endodontics, Thaimoogambigai Dental College and Hospital, golden george nagar, Mogappair, Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A R Pradeep Kumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Thaimoogambigai Dental College and Hospital |
| Address |
Department of conservative dentistry and Endodontics, Thaimoogambigai Dental College and Hospital, golden george nagar, Mogappair, Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sai Saranya Koya, MNK Vittal Central Court flat no 515, new Bhoiguda, 500003 |
|
|
Primary Sponsor
|
| Name |
Sri Sai Saranya Koya |
| Address |
MNK Vittal Central Court flat no 515, new Bhoiguda, 500003 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ACS Advanced Medical Research and Institute |
Maduravoyal, Chennai 600095 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sri Sai Saranya Koya |
Thaimoogambigai Dental College and Hospital |
Room no 202, department of
conservative dentistry and Endodontics
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9966300849
ksaisaranya36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics review board of Dr MGR Educational and Research Institute, 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 |
Teeth with premature occlusal contacts |
Premature occlusal contacts are eliminated and checked for strain immediately and after 1 month |
| Comparator Agent |
Teeth without premature occlusal contacts |
Teeth without premature contacts are checked for strain values immediately and after 1 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with complete dentition, not necessarily with the presence of third molars, with Angle’s class 1 or 2 malocclusion and group function, teeth with occlusal stress not along the long axis of the tooth
|
|
| ExclusionCriteria |
| Details |
Patients with caries or cervical restorations, severe periodontal disease , ongoing orthodontic treatment, pulpal diagnosis of pulp necrosis, apical diagnosis of symptomatic apical periodontitis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Elimination of premature tooth contact reduces tooth strain |
Strain value is checked before & immediately after elimination of premature contact & 6 months post operative |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/11/2023 |
| 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 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 aim of the study is to identify occlusal interferences and recorded in maximum intercuspation. T-scan evaluation to check for premature contacts. Bite force is evaluated using Flexiforce ( Tekscan ). Strain is evaluated for test tooth and contralateral tooth. Premature contact is eliminated with airotor and bur. Bite force, strain and t-scan evaluation is repeated. Evaluating the strain values in the test tooth and comparing if the strain values are comparable to that of the control tooth. |