Periapical DiseasesNCT06243601
Effect of Aloe Vera Gel as an Intra Canal Medicament
A study testing Aloe vera Gel in people with Periapical Diseases, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- Aloe vera Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Nov 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both male and female patients presenting with asymptomatic periapical lesions in permanent teeth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aloe Vera Gel as an Intra Canal Medicament in Patients With Asymptomatic Periapical Lesions.
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.
Read the detailed description
Objective: To evaluate the effect of aloe vera gel based on clinical signs and symptoms as an intracanal medicament in asymptomatic periapical lesions over a period of three weeks. 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. Patients will be randomly divided into two groups by randomization in Statistical Package for Social Sciences software (SPSS v24.0). They 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. Statistical analysis: Descriptive statistics will be used for reporting age. Frequencies and percentages will be calculated for categorical variables and intergroup comparison will be done by chi square test
- Conditions
- Periapical Diseases
- Being tested
- Aloe vera Gel
- Keywords
- Antibacterial, Analgesic, Clinical signs and symptoms
- Medical subject headings
- Periapical Diseases, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Aloe vera Gel |
| Control Group | No intervention | No intracanal medicament will be placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start30 Nov 2023
- Primary completion20 Aug 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saima Azam, BDS,FCPS, Principal investigator, Islamabad Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243601
- Sponsor's protocol ID
- IslamabadDentalHospital
- Status last verified
- May 2025
- First submitted
- 29 Jan 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aloe Vera Gel as an Intra Canal Medicament in Patients With Asymptomatic Periapical Lesions.
- ClinicalTrials.gov ID
- NCT06243601
- Acronym / sponsor ID
- IslamabadDentalHospital
- Conditions
- Periapical Diseases
- Keywords
- Antibacterial, Analgesic, Clinical signs and symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: To evaluate the effect of aloe vera gel based on clinical signs and symptoms as an intracanal medicament in asymptomatic periapical lesions over a period of three weeks. 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. Patients will be randomly divided into two groups by randomization in Statistical Package for Social Sciences software (SPSS v24.0). They 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. Statistical analysis: Descriptive statistics will be used for reporting age. Frequencies and percentages will be calculated for categorical variables and intergroup comparison will be done by chi square test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Biological: Aloe vera GelFresh AVG will be prepared. It will be placed as intracanal medicament after cleaning and shaping in patients with asymptomatic periapical lesions |
| Control Group | No intervention | –No intracanal medicament will be placed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Both male and female patients presenting with asymptomatic periapical lesions in permanent teeth
Key exclusion criteria (6 listed)
- History of allergy to AVG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloe vera GelA 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. | Biological | Intervention Group |
Primary outcome
Presence or absence of signs and symptoms of the patient
Time frame: One week and 3 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saima Azam, BDS,FCPS principal investigator
Islamabad Dental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aloe vera Gel in people with Periapical Diseases, run by Islamabad Medical and Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of signs and symptoms of the patient (time frame: One week and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.