| CTRI Number |
CTRI/2023/11/059716 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
In vivo evaluation of bite force and strain alterations during root canal treatment in maxillary premolars
|
|
Scientific Title of Study
|
Evaluation of bite force and strain alterations during root canal treatment in maxillary premolars |
| 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. Abhiraj Gudugunti |
| Designation |
MDS |
| Affiliation |
Thai moogambigai dental college and hospital |
| Address |
Department of conservative dentistry and endodontics,thai moogambigai dental college and hospital,chennai
Chennai
TAMIL NADU
6000107
India |
| Phone |
9741221902 |
| Fax |
|
| Email |
abhiraj18395@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. A R Pradeep kumar |
| Designation |
Professor and head of the department |
| Affiliation |
Thai moogambigai dental collage and hospital |
| Address |
Department of conservative dentistry and endodontics,thai moogambigai dental college and hospital,chennai
Chennai
TAMIL NADU
6000107
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 the department |
| Affiliation |
Thai moogambigai dental collage and hospital |
| Address |
Department of conservative dentistry and endodontics,thai moogambigai dental college and hospital,chennai
TAMIL NADU
6000107
India |
| Phone |
9840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thai Moogambigai dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Abhiraj Gudugunty |
| Address |
Abhiraj Nilaya Pampa Housing Colony, Manvi - 584123
Karnataka |
| 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 Abhiraj gudugunty |
Thai Moogambigai Dental College and hospital |
Room no 202,department of conservative dentistry and endodontics, chennai,TAMIL NADU
Chennai
TAMIL NADU |
9741221902
abhiraj18395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics review board of Dr M.G.R Educational and research institute,University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Lost one marginal ridge due to dental caries
Symptomatic irreversible pulpitis
Asymptomatic apical periodontitis
Mature root apex
Group-1 (20-30 years)
Group-2 (50-60 years)
|
|
| ExclusionCriteria |
| Details |
Presence of fixed prostheses
Orthodontic treatment
Presence of malocclusion
Pulp necrosis
Symptomatic apical periodontitis
Periodontally compromised teeth
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Does coronal strain alters during root canal treatment in old & young age group. |
Before Local anesthesia,after local anesthesia,after access opening,after obturation,after core. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Does bite force alters during root canal treatment in the old & young age group |
Before local anesthesia,after local anesthesia,after core |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/12/2023 |
| 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
|
This study aimed to evaluate bite force and strain alterations under occlusal load in maxillary premolars before and after root canal treatment in two different age groups. Patients were categorized into 2 groups (1. Young age,2.Old age). The coronal strain and bite force were evaluated before and during root canal treatment.
|