Effect of Aloe Vera Gel as an Intra Canal Medicament

Effect of Aloe Vera Gel as an Intra Canal Medicament in Patients With Asymptomatic Periapical Lesions.

Methodology: Fresh AVG will be prepared. It will be placed as intracanal medicament after cleaning and shaping in patients with asymptomatic periapical lesions in group A while in group B (control group) no intracanal medicament will be placed. Patient will be recalled for one week and three week follow ups and in case of no clinical signs and symptoms endodontic procedure will be completed. In case of pain normal routine procedure will be followed.

Study Overview

• Status: Recruiting
• Conditions: Effect of Aloe Vera Gel as an Intracanal Medicament in Asymptomatic Periapical Lesions
• Intervention / Treatment: Biological: Aloe vera Gel

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Recruiting
      • Islamabad Dental Hospital
      • Contact: Urooj Khan, BDS; Phone Number: +923137863339; Email: uroojkhan1996@yahoo.com
      • Contact: Saima Azam, BDS,FCPS; Phone Number: 00923005350740; Email: saima.azam@iideas.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both male and female patients presenting with asymptomatic periapical lesions in permanent teeth

Exclusion Criteria:

• History of allergy to AVG

  • Comorbidities likely to impair healing
  • Pregnant women
  • History of previous endodontic treatment in the same tooth
  • Presence of pulp calcification
  • Internal or external root resorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Biological: Aloe vera Gel; A fresh aloe vera (Aloe Barbadensis) leaf will be plucked from the plant. The leaf will be washed with normal saline, peeled with scalpel and the inner gel will be blended in a blender to convert it into a watery consistency. The solution will be stored in an autoclaved flask.
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of signs and symptoms of the patient	Patients in both the groups will be recalled after one week. They will be assessed clinically for either presence or absence of signs and symptoms.; In cases of absence of clinical signs and symptoms, endodontic treatment will be completed.; In cases where patient returns with presence of clinical signs and symptoms, dressing will be removed, and canals will be irrigated with sodium hypochlorite followed by saline. After drying the canals, in group A, AVG will be placed in the canals and tooth restored temporarily while in group B, cotton pellet will be placed in the canals and tooth restored temporarily. The patients will be recalled after two weeks.; If a patient reports with acute symptomsin either of the groups, the protocols to manage acute infection will be followed.	One week and 3 weeks

Collaborators and Investigators

• Sponsor: Islamabad Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IslamabadDentalHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No