| CTRI Number |
CTRI/2023/07/055396 [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 Trial |
|
Public Title of Study
|
Effect of Calcium Hydroxide as an intracanal medicament with aqueous and viscous based vehicles in patients with pulpal necrosis and symptomatic apical periodontitis on post operative pain and healing outcome |
|
Scientific Title of Study
|
Comparative Evaluation of Calcium Hydroxide as an Intracanal Medicament with Aqueous and Viscous Based Vehicles in Patients with Pulpal Necrosis and Symptomatic Apical Periodontitis: Impact on Postoperative Pain and Healing Outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lubhansha Kumar |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Denatal College, Department of Conservative Dentistry & Endodontics, Room no. 7
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
Faridabad
HARYANA
121003
India |
| Phone |
8826474748 |
| Fax |
|
| Email |
guptalubhansha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dax Abraham |
| Designation |
Professor and Head of the department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
Department of Conservative Dentistry and Endodontics, Room no. 7
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
121003
Faridabad
HARYANA
121003
India |
| Phone |
9910433111 |
| Fax |
|
| Email |
daxabraham.mrdc@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dax Abraham |
| Designation |
Professor and Head of the department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College Department of Conservative Dentistry and Endodontics, Room no.7
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana
121003
Faridabad
HARYANA
121003
India |
| Phone |
9910433111 |
| Fax |
|
| Email |
daxabraham.mrdc@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lubhansha Kumar |
| Address |
Manav Rachna Dental College Departemtn of conservative dentistry and Endodontics, Room no.7 Sector – 43,Delhi, Suraj Kund Badkhal Rd, 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 |
| Dax Abraham |
Manav Rachna Dental College |
Department of Conservative Dentistry and Endodontics, Room no. 7,Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121003
Faridabad
HARYANA |
9910433111
daxabraham.mrdc@mrei.ac.in |
|
|
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: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propylene Glycol group
|
25 patients with caclium hydroxide and propylene glycol as intracanal medicament for a period of 7 days |
| Intervention |
Saline group |
25 patients with calcium hydroxide and 0.2% saline as intracanal medicament for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular molars diagnosed with Pulp necrosis and Symptomatic apical periodontitis and
Teeth with mature apices
|
|
| ExclusionCriteria |
| Details |
Patients who had taken analgesics or anti-inflammatory drugs within the last 12 hours,
Teeth with calcified canals and aberrant root canal morphology,
Pregnant or lactating patients,
Patients with history of allergy to any of the components of local anesthesia,
Teeth with previous RCT,
Severely damaged or mutilated teeth,
Patients with any systemic diseases,
|
|
|
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 expected in the level of post-operative pain & healing |
post operative pain will be evaluated at 6, 24,48 & 72 hours
Periapical healing will be evaluated at 3,6,9 & 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Differences expected in the level of post operative pain & healing in patients of pulpal necrosis & symptomatic apical periodontitis after placing calcium hydroxide with aqueous & viscous vehicles |
Post operative pain will be evaluated at 6, 24, 48 &72 hours
Periapical healing will be evalauted at 3,6,9 & 12 months by comparing the pre operative & post operative Periapical Index(PAI) Score |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: This study aimed to evaluate the effect of calcium hydroxide used as an intracanal medicament with aqueous and viscous based vehicles on postoperative pain and healing outcomes in patients diagnosed with pulpal necrosis and symptomatic apical periodontitis. Methods: A randomized controlled trial was conducted with a sample of patients presenting with pulpal necrosis and symptomatic apical periodontitis. The participants were divided into two groups: one receiving calcium hydroxide with an aqueous vehicle and the other with a viscous vehicle. The medicament was applied during root canal treatment. Postoperative pain levels and healing outcomes were assessed using pain scales and radiographic examination, respectively. Results: Both groups demonstrated effective delivery of calcium hydroxide to the affected area. Postoperative pain levels significantly decreased in both groups compared to baseline, with no statistically significant difference between the two groups. Radiographic examination revealed comparable periapical healing outcomes in both groups. Conclusion: Calcium hydroxide used as an intracanal medicament with aqueous and viscous based vehicles showed similar efficacy in reducing postoperative pain and promoting healing in patients with pulpal necrosis and symptomatic apical periodontitis. The choice of vehicle can be based on clinical preference. Further research is needed to explore additional factors influencing postoperative pain and healing outcomes. |