| CTRI Number |
CTRI/2023/07/055398 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study where we will compare the healing effects of different aqueous-based vehicles used for mixing calcium hydroxide powder and placing it in the root canals during the inter-appointment period while treating patients with pulpal necrosis & symptomatic apical periodontitis. |
|
Scientific Title of Study
|
Healing outcome of different aqueous based calcium hydroxide intracanal medicament in patients with pulpal necrosis and symptomatic apical periodontitis: a randomized controlled 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 |
UNNATI SOMA |
| Designation |
PG STUDENT |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE |
| Address |
Room no T03, girls hostel, gate number 10, MANAV RACHNA DENTAL COLLEGE, SURAJ KUND BADKHAL ROAD, SECTOR43, 121003, FARIDABAD, HARYANA
Department of conservative dentistry and endodontics. manav rachna dental college, faridabad.
Faridabad
HARYANA
121003
India |
| Phone |
8329198017 |
| Fax |
|
| Email |
unnatibamania9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ALPA GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE |
| Address |
DEPARTMENT NUMBER 7, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, MANAV RACHNA DENTAL COLLEGE, SURAJ KUND BADKHAL ROAD, SECTOR43, 121003, FARIDABAD, HARYANA
Faridabad
HARYANA
121003
India |
| Phone |
9050312010 |
| Fax |
|
| Email |
alpagupta2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ALPA GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE |
| Address |
MANAV RACHNA DENTAL COLLEGE, SURAJ KUND BADKHAL ROAD, SECTOR43, 121003, FARIDABAD, HARYANA
Department of conservative dentistry and endodontics. manav rachna dental college, faridabad.
Faridabad
HARYANA
121003
India |
| Phone |
9050312010 |
| Fax |
|
| Email |
alpagupta2008@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Unnati Soma |
| Address |
Room number t03, girls hostel, gate number 10, Manav Rachna Dental College, Suraj Kund Badkhal road, Sector 43, Faridabad, Haryana |
| 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 |
| Alpa Gupta |
MANAV RACHNA DENTAL COLLEGE |
Room number T03, girls hostel, gate number 10, Manav Rachna Dental College, Suraj Kund Badkhal road, Sector 43, Faridabad, Haryana
Faridabad
HARYANA |
9050312010
alpagupta2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF MANAV RACHNA DENTAL COLLEGE |
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 |
Group 1 |
25 patients with intracanal medicament as Calcium hydroxide mixed with zero point 9 percent saline solution for 7 days
|
| Intervention |
Group 2 |
25 patients with intracanal medicament as Calcium hydroxide mixed with 2 percent lidocaine hydrochloride solution for 7 days
|
| Intervention |
Group 3 |
25 patients with intracanal medicament as Calcium hydroxide mixed with 2 percent chlorhexidine solution for 7 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular molar teeth diagnosed with symptomatic apical periodontitis and pulpal necrosis,
Teeth with mature apices |
|
| ExclusionCriteria |
| Details |
Patients with periodontal disease or systemic disorders, patients taking steroids, pregnant patients, or patients with a history of antibiotic intake in the preceding month,
Patients with a history of allergy to any of the components of local anesthesia, chlorhexidine, EDTA, or sodium hypochlorite,
Teeth with previous RCT,
Severely damaged or mutilated teeth,
Patients not willing to participate in the study and did not sign the consent form.
|
|
|
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 |
| Differences were expected in apical bone density by comparing the pre-operative PAI scoring & post-operative PAI scoring. |
Periapical healing at 3months 6 months 9 months & 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the difference in apical bone density by comparing the pre-operative PAI scoring & post-operative PAI scoring. |
Periapical healing at 3months 6 months 9 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 2 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to investigate the healing outcome of different aqueous-based calcium hydroxide intracanal medicaments in patients with pulpal necrosis and symptomatic apical periodontitis. The primary objective is to evaluate the healing process by comparing pre-treatment and post-treatment observations. A total sample size of 75 patients will be divided into three groups, with each group consisting of 25 patients. The three different aqueous vehicles used for the medicaments are 0.9% saline, 2% chlorhexidine, and 2% lignocaine. The study aims to determine the comparative effectiveness of these aqueous vehicles in promoting healing in the target population. The findings of this research have the potential to contribute valuable insights into the optimal choice of an intracanal medicament for enhancing healing outcomes in patients with pulpal necrosis and symptomatic apical periodontitis. |