| CTRI Number |
CTRI/2023/07/054733 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation Of Post Operative Pain Using Different Aqueous Vehicles Of Calcium Hydroxide in diabetic & non diabetic patients. |
|
Scientific Title of Study
|
To Compare The Impact Of Different Aqueous Vehicles Used In Calcium Hydroxide Medicament On Post Operative Pain In Diabetic vs Non-Diabetic Patient With Symptomatic Apical Periodontitis : A Double Blind Randomized Control Trial.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TOOPALLE SAI VAKUL |
| Designation |
post graduate student |
| Affiliation |
Manav Rachna Dental college |
| Address |
manav rachna dental college,suraj kund badkhal road ,faridabad
manav rachna dental college,suraj kund badkhal road ,faridabad
Faridabad
HARYANA
121004
India |
| Phone |
7793975916 |
| Fax |
|
| Email |
tvakul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ALPA GUPTA |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental college |
| Address |
manav rachna dental college,suraj kund badkhal road ,faridabad
manav rachna dental college,suraj kund badkhal road ,faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9050312010 |
| Fax |
|
| Email |
alpagupta2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TOOPALLE SAI VAKUL |
| Designation |
post graduate student |
| Affiliation |
Manav Rachna Dental college |
| Address |
manav rachna dental college,suraj kund badkhal road ,faridabad
manav rachna dental college,suraj kund badkhal road ,faridabad
Karimnagar
HARYANA
121004
India |
| Phone |
7793975916 |
| Fax |
|
| Email |
tvakul@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sai Vakul Toopalle |
| Address |
manav rachna dental college,suraj kund badkhal road ,faridabad
ROAD NO.5 |
| Type of Sponsor |
Other [private dental 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 |
| toopalle sai vakul |
manav rachna dental college |
manav rachna dental college,suraj kund badkhal road ,faridabad
Faridabad
HARYANA |
7793975916
tvakul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium hydroxide and lidocaine vehicle |
calcium hydroxide as an intracanal medicament with lidocaine as a vehicle in diabetic patients |
| Intervention |
calcium hydroxide with 0.2% chlorhexidine as vehicle |
calcium hydroxide as an intracanal medicament with 0.2 % chlorhexidine as vehicle in diabetic patients |
| Comparator Agent |
calcium hydroxide with 0.2% chlorhexidine as vehicle |
calcium hydroxide as an intracanal medicament with 0.2% chlorhexidine as a vehicle in non diabetic patients |
| Comparator Agent |
calcium hydroxide with lidocaine as vehicle |
calcium hydroxide as an intracanal medicament with lidocaine as a vehicle in non diabetic patients |
| Comparator Agent |
calcium hydroxide with saline as vehicle |
calcium hydroxide as an intracanal medicament with saline as a vehicle in non diabetic patients |
| Intervention |
Calcium hydroxide with saline as vehicle |
calcium hydroxide as intracanal medicament using saline as a vehicle in diabetic patients |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a)Mandibular posterior teeth diagnosed with Symptomatic
Apical periodontitis and pulp necrosis
b)Teeth with mature apices
c) Patients with age between 35 - 70 yrs
d)Non diabetic patients with HBA1C LEVELS <5.4 %
Uncontrolled Diabetic patients with HBA1C levels
>7.0
|
|
| ExclusionCriteria |
| Details |
a) Patients who had taken analgesics or anti-inflammatory
drugs within the last 12 hours.
b)Teeth with calcified canals and aberrant root canal
morphology.
c) Pregnant or lactating patients
d)Patients with history of allergy to any of the components of
local anesthesia
e)Teeth with previous RCT
f) Severely damaged or mutilated teeth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of
different aqueous vehicles used
in calcium hydroxide
medicament on post operative
pain in uncontrolled diabetic
and non diabetic patients
|
Postoperative pain will be evaluated after 6, 24, 48, 72 hours & consecutively for 4
more days with the help of heft parker scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effects of
saline , 2% chlorhexidine,
lidocaine hydrochloride when
used as vehicles with calcium
hydroxide to evaluate impact
of post operative pain |
Postoperative pain will be evaluated after 6, 24, 48, 72 hours & consecutively for 4
more days with the help of heft parker scale |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| Date of Study Completion (India) |
09/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
manuscript will be prepared for submission |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
subjects in calcium hydroxide with chlorhexidine showed a lower post operative pain than other groups |