| CTRI Number |
CTRI/2024/12/078546 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the level of bacteria in the teeth after placing different medicaments |
|
Scientific Title of Study
|
Evaluation of Efficacy of Calcium Hydroxide and Simvastatin as Intracanal Medicament Using ATP Bioluminescence Meter: A Randomized Clinical Trial.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagala Tejaswini |
| Designation |
PG student |
| Affiliation |
Sibar institute of dental sciences |
| Address |
PG student
Department of conservative dentistry and endodontics
Sibar institute of dental sciences
Takkellapadu
Guntur
Andhra pradesh
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9704224633 |
| Fax |
|
| Email |
drpvstejaswiniyadavsmds2022@sids.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sagala Tejaswini |
| Designation |
Postgraduate |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Postgraduate
Department of conservative dentistry and endodontics
Sibar institute of dental sciences
Takkellapadu
Guntur
Andhra pradesh
India
ANDHRA PRADESH
522509
India |
| Phone |
9704224633 |
| Fax |
|
| Email |
drpvstejaswiniyadavsmds2022@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ram chowdary Basam |
| Designation |
Reader |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Reader
Department of conservative dentistry and endodontics
Sibar institute of dental sciences
Takkellapadu
Guntur
Andhra pradesh
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8106755123 |
| Fax |
|
| Email |
ramchowdaryendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Randolph Cross D.D.S. A Professional Corporation. 475 Sumner Ave, Aptos CA 95003, United States of America |
|
|
Primary Sponsor
|
| Name |
Sagala Tejaswini |
| Address |
Postgraduate
Department of conservative dentistry and endodontics
Sibar institute of dental sciences
Takkellapadu
Guntur
Andhra pradesh
India |
| 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 |
| Dr Sagala Tejaswini |
Sibar institute of dental sciences |
Room Number 5
Postgraduate student
Department of conservative dentistry and endodontics
Sibar institute of dental sciences
Takkellapadu
Guntur
Andhra pradesh
India
Guntur
ANDHRA PRADESH |
09704224633
drpvstejaswiniyadavsmds2022@sids.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Removal of calcium hydroxide |
To evaluate the ATP levels in the root canal system after root canal instrumentation and after removal of calcium hydroxide intracanal medicament after 7 days |
| Intervention |
Removal of simvastatin intracanal medicament |
To evaluate the ATP levels in the root canal system after root canal instrumentation and after removal of simvastatin intracanal medicament after 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with pulp necrosis and symptomatic apical periodontitis
Patients diagnosed with pulp necrosis and chronic apical abscess
Patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis
Patients diagnosed with pulp necrosis and acute apical abscess |
|
| ExclusionCriteria |
| Details |
patients diagnosed with absence of pain
patients who are not willing to participate in the study
patients diagnosed with root fractures |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of ATP levels(microbial load level) after root canal instrumentation and after removal of simvastatin and calcium hydroxide |
Evaluation of ATP levels (indicative of microbial load) after root canal instrumentation at 45 minutes and following the removal of simvastatin and calcium hydroxide after one week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative pain evaluation after placement of simvastatin and calcium hydroxide and after their removal |
post operative pain evaluation after placement of simvastatin and calcium hydroxide at 8hrs,24hrs,48hrs,72hrs and after their removal at 7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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="1"
Months="1"
Days="1" |
|
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
|
Primary purpose of the study: To evaluate the microbial levels(ATP levels) after root canal instrumentation and after removal of simvastatin and calcium hydroxide intracanal medicament.
Hypothesis: To evaluate the microbial levels after root canal instrumentation and after removal of simvastatin and calcium hydroxide intracanal medicament.
Null
hypothesis:
There is no significant difference in ATP levels before and after calcium hydroxide intracanal medicament.There is no significant difference in ATP levels before and after simvastatin
intracanal medicament.There is no
significant difference in ATP levels between calcium hydroxide and simvastatin as intracanal medicament.
Alternative hypothesis:
There is
significant difference in ATP levels before and after calcium
hydroxide intracanal medicament.There
is significant difference in ATP levels before and after simvastatin
intracanal medicament.There is
significant difference in ATP levels between calcium hydroxide and
simvastatin as intracanal medicament. Study design: 100 patients diagnosed with pulp necrosis with symptomatic apical periodontitis will be recruited from outpatient. After randomization, patients will be treated with either simvastatin and calcium hydroxide intracanal medicament. After removal of simvastatin and calcium hydroxide intracanal medicament, 100ul liquid collected in syringe will be used for testing ATP levels using Bioluminescence meter.
|