NCT06243601

Brief Summary

This research will overview the effect of aloe vera gel (AVG) as intra canal medicament in patients with asymptomatic periapical lesions. It will provide endodontists with scientific evidence regarding the beneficial use of AVG as an intracanal medicament owing to its superior antibacterial and analgesic properties as compared to routinely used commercial intra canal medicaments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

January 29, 2024

Last Update Submit

May 16, 2025

Conditions

Keywords

Antibacterial, Analgesic, Clinical signs and symptoms

Outcome Measures

Primary Outcomes (1)

  • 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. 1. In cases of absence of clinical signs and symptoms, endodontic treatment will be completed. 2. 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. 3. 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Fresh AVG will be prepared. It will be placed as intracanal medicament after cleaning and shaping in patients with asymptomatic periapical lesions

Biological: Aloe vera Gel

Control Group

NO INTERVENTION

No intracanal medicament will be placed

Interventions

Aloe vera GelBIOLOGICAL

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.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamabad Dental Hospital

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Periapical DiseasesSigns and Symptoms

Interventions

Aloe vera gel

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPathological Conditions, Signs and Symptoms

Study Officials

  • Saima Azam, BDS,FCPS

    Islamabad Dental Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 6, 2024

Study Start

November 30, 2023

Primary Completion

August 20, 2024

Study Completion

November 15, 2024

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations