| CTRI Number |
CTRI/2025/03/082098 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effectiveness of two different materials on healing of infection in upper front teeth |
|
Scientific Title of Study
|
Evaluation of Local Drug Delivery with Simvastatin incorporated hydrogel in treatment of periapical lesions: A 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 |
Gaurav Sharma |
| Designation |
Post graduate |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room 9, Department of conservative dentistry and endodontics, Army College of Dental Sciences, Jai jawahar Nagar, CRPF road, Secunderaad, Telangana
Medchal
TELANGANA
500087
India |
| Phone |
09535433129 |
| Fax |
|
| Email |
gaurav.sharma91196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta Kaushik |
| Designation |
Principal and Head of Department |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room 9, Department of conservative dentistry and endodontics, Army College of Dental Sciences, Jai jawahar Nagar, CRPF road, Secunderaad, Telangana
Medchal
TELANGANA
500087
India |
| Phone |
09535433129 |
| Fax |
|
| Email |
mamkaushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Sharma |
| Designation |
Post graduate |
| Affiliation |
Army College of Dental Sciences |
| Address |
Room 9, Department of conservative dentistry and endodontics, Army College of Dental Sciences, Jai jawahar Nagar, CRPF road, Secunderaad, Telangana
TELANGANA
500087
India |
| Phone |
09535433129 |
| Fax |
|
| Email |
gaurav.sharma91196@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army College of Dental sciences, Jai Jawahar Nagar, Secunderabad, Telangana, India, 500087 |
|
|
Primary Sponsor
|
| Name |
Gaurav Sharma |
| Address |
Room 9 , Department of conservative dentistry and endodontics, Army College of Dental Sciences, CRPF road, Secunderabad, Telangana |
| Type of Sponsor |
Private medical college |
|
|
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 Gaurav Sharma |
Army College of Dental Sciences |
Room No 9, Department of conservative dentistry and endodontics, Army College of Dental Sciences, CRPF Road, Jai Jawahar Nagar, Secunderabad
Medchal
TELANGANA |
9535433129
gaurav.sharma91196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army College of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic/asymptomatic apical periodontitis with chronic periapical abscess/granuloma |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Hydroxide |
Calcium Hydroxide used as an intra canal medicament for treatment of periapical lesions in maxillary anterior region and evaluation after 1,3 and 6 months |
| Intervention |
Simvastatin hydrogel |
Simvastatin hydrogel used as an intra canal medicament for treatment of periapical lesions in maxillary anterior region and evaluation after 1,3 and 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with chronic apical periodontitis in the Maxillary Anterior teeth with periapical lesions as seen on the radiograph
Patient provides informed consent
|
|
| ExclusionCriteria |
| Details |
Unwilling patients
Patients with obstructed canals
Smokers and alcoholics
Pregnant and lactating women
Periodontally compromised teeth
Patients with bleeding disorders
Patients who have an allergy to Simvastatin
Patients on oral Simvastatin
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in size of periapical lesion in maxillary anterior teeth after using simvastatin, calcium hydroxide as intra canal medicament |
1 month
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of simvastatin hydrogel as an intra canal medicament |
1 month
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="8"
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
|
Patients fitting the inclusion criteria will be selected. Informed consent will be taken. Local anesthesia will be administered. The concerned teeth will be isolated using rubber dam. Access opening, working length, cleaning and shaping(till F3, F4 or F5) will be done for the concerned teeth. The irrigation protocol followed will be 3% sodium hypochlorite and 17% EDTA followed by saline as final rinse. The placement of simvastatin hydrogel or calcium hydroxide as an intra canal medicament will be done using a syringe through the teeth and a temporary restoration will be placed. The patient will be recalled after 1 week for obturation followed by a permanent restoration using Glass ionomer cement. 1, 3 and 6 months follow up will be done. For preparation of Simvastatin hydrogel- Pure simvastatin will be obtained. 1.2% Simvastatin hydrogel will be prepared by ,mixing it with poloxamer. |