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Necrotic Teeth With Apical PeriodontitisNCT07826091

Evaluation of the Aloe Vera Anti-inflammatory Effect on Apical Periodontitis.

A study testing Aloe vera gel and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Necrotic Teeth With Apical Periodontitis, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to evaluation aloe vera as intracanal medication anti-inflammatory also inter-appointment pain incidence compared with calcium hydroxide. The main questions it aims to answer are: Does aloe vera reduced pro-inflammatory cytokine (IL-1b)? Researchers will compare aloe vera to calcium… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Necrotic Teeth With Apical Periodontitis
What is being tested?
Aloe vera gel and Calcium Hydroxide (Ca(OH)2) Intracanal Medication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteEgypt
Study dates
5 Aug 2024to 17 Feb 2026
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both genders.
  • Older than the age of 18 years.
  • Medically free patients.
  • Participants should be willing to commit for the entire period of the trial and agreed to sign the written informed consent after complete explanation of the study protocol.
  • Participants with single rooted necrotic teeth with apical periodontitis, symptomatic (Visual analogue scale "VAS" and pain on percussion) or Asymptomatic (Radiographic evidence of apical periodontitis).

Who cannot join

  • Presence of Allergic reaction.
  • Participants taking antibiotics or NSAIDs.
  • Severely curved root.
  • Endodontically treated teeth.
  • Teeth with open apices.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of dentistry, Ain shams university

    Cairo, Abbasia, 11566

Other trials in Egypt

About this study

Official title: Evaluation of the Aloe Vera Anti-inflammatory Effect on Apical Periodontitis, Randomized Clinical Trial; In Vivo Study

The goal of this clinical trial is to evaluation aloe vera as intracanal medication anti-inflammatory also inter-appointment pain incidence compared with calcium hydroxide. The main questions it aims to answer are:

Does aloe vera reduced pro-inflammatory cytokine (IL-1b)? Researchers will compare aloe vera to calcium hydroxide intra-canal medication to see if it works to modulate the inflammatory response in necrotic teeth with apical periodontitis.

Read more

Participants will:

Receive the intra-canal medications following root canal preparation for 14 days, periapical tissue fluid samples will be collected after access cavity preparation and 14days post medication placement.

Pre-operative pain level and 24h, 48h post medication placement will be recorded.

Read the detailed description

After recording pre-operative pain level using 10-pont VAS, anesthetization, the caries lesion was removed and the tooth isolated with rubber dam (Sanctuary). The missing walls of the tooth was restored using composite resin to ensure proper isolation and seal. Then with sterile burs, access cavity preparation was done.

Patency was gained and the canal was flushed with 3ml of saline to remove any debris in the canal that will interfere with the paper points and ensure accurate electronic apex locator reading. Then working length was measured by K files using electronic apex locator for accuracy and confirmed with periapical radiograph.

The canal was then dried to the working length with paper points then the first sample (S1) was taken by 3 paper points depending on the size of the initial file extended beyond the apical foramen 1-2mm and left in place for 30 sec using digital stopwatch. The collected sample was placed in Eppendorf tube and stored at -20°C for further analysis following the ELISA manufacture instructions ( Elabscience® Human IL-1β(Interleukin 1 Beta) ELISA Kit).

Chemo-Mechanical preparation of the canal was done using rotary files and 5.25% sodium hypochlorite diluted 1:1. The canal was dried using paper points then filled with Aloe Vera, calcium hydroxide or no medication depending on the subjects grouping, giving that G1 (n=11) of no medication, G2 (n=11) filled with Ca(OH)₂ while G3 (n=11) filled with aloe vera paste. The access cavity was sealed using sterile teflon and 2mm of composite resin.

At 24h,48h post intra-canal medication placement, pain level was recorded. At the second visit 14 days postoperatively, the canal was flushed with saline to remove the ICM and dried using paper points then sample 2 (S2) was collected following the same procedures as S1 then master cone adjustment and obturation were done.

After collecting samples from all patients, the samples were evaluated by the enzyme-linked immunosorbent assay (ELISA) method.

Being tested
Aloe vera gel, Calcium Hydroxide (Ca(OH)2) Intracanal Medication
Keywords
Apical periodontitis, pro-inflammatory cytokines, IL-1β, aloe vera, calcium hydroxide, intracanal medications
Medical subject headings
Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aloe vera gelDrug

    Also called aloe vera intra-canal paste

    aloe vera gel concentration is (100% w/v).

  • Calcium Hydroxide (Ca(OH)2) Intracanal MedicationDrug

    Also called Metapaste, CH

    <30% wt

Study groups in NCT07826091
Study groupRoleWhat they receive
First group (G1), negative control groupNo interventionwill not receive any intra-canal medication
second group (G2), Medication A, Calcium hydroxideActive comparatorCalcium hydroxide (Metapaste)
Receives: Drug: Calcium Hydroxide (Ca(OH)2) Intracanal Medication
Group 3 (G3), medication B, Aloe veraExperimentalAloe vera gel
Receives: Drug: Aloe vera gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To detect Aloe Vera effect on pro-inflammatory by detecting cytokine IL-β level

    Detected using ELISA

    Measured: 14 days

Secondary outcomes (1)

  1. inter-appointment incidence of pain using VAS

    10-point VAS (levels 0-3, mild pain, levels 4-7, moderate pain, and levels 8-10 indicates severe pain).

    Measured: 24hours, 48hours post intracanal medication placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start5 Aug 2024
  3. Primary completion17 Feb 2026
  4. Study completion17 Feb 2026

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07826091
Sponsor's protocol ID
FDASU-Rec IM012463
Status last verified
Mar 2024
First submitted
5 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Virdee SS, Butt K, Grant M, Camilleri J, Cooper PR, Tomson PL. A systematic review of methods used to sample and analyse periradicular tissue fluid during root canal treatment. Int Endod J. 2019 Aug;52(8):1108-1127. doi: 10.1111/iej.13104. Epub 2019 Mar 27.

    PubMed 30802974

  • Parashar V, Khan SA, Singh P, Sharma S, Kumar A, Kumar A. Effect of Intracanal Medicaments (Modified Triple Antibiotic Paste, Calcium Hydroxide, and Aloe Vera) on Microhardness of Root Dentine: An In Vitro Study. J Contemp Dent Pract. 2020 Jun 1;21(6):632-635.

    PubMed 33025931

  • Abbaszadegan A, Sahebi S, Gholami A, Delroba A, Kiani A, Iraji A, Abbott PV. Time-dependent antibacterial effects of Aloe vera and Zataria multiflora plant essential oils compared to calcium hydroxide in teeth infected with Enterococcus faecalis. J Investig Clin Dent. 2016 Feb;7(1):93-101. doi: 10.1111/jicd.12123. Epub 2014 Sep 4.

    PubMed 25187255

  • Arunkumar S, Muthuselvam M. Analysis of phytochemical constituents and antimicrobial activities of Aloe vera L. against clinical pathogens. World J Agric Sci 2009;5:572-6

  • Barbosa-Ribeiro M, Arruda-Vasconcelos R, de-Jesus-Soares A, Zaia AA, Ferraz CCR, de Almeida JFA, Gomes BPFA. Effectiveness of calcium hydroxide-based intracanal medication on infectious/inflammatory contents in teeth with post-treatment apical periodontitis. Clin Oral Investig. 2019 Jun;23(6):2759-2766. doi: 10.1007/s00784-018-2719-0. Epub 2018 Oct 26.

    PubMed 30367257

  • Martinho FC, Gomes CC, Nascimento GG, Gomes APM, Leite FRM. Clinical comparison of the effectiveness of 7- and 14-day intracanal medications in root canal disinfection and inflammatory cytokines. Clin Oral Investig. 2018 Jan;22(1):523-530. doi: 10.1007/s00784-017-2143-x. Epub 2017 Jun 6.

    PubMed 28589472

  • Silva TA, Garlet GP, Fukada SY, Silva JS, Cunha FQ. Chemokines in oral inflammatory diseases: apical periodontitis and periodontal disease. J Dent Res. 2007 Apr;86(4):306-19. doi: 10.1177/154405910708600403.

    PubMed 17384024

  • Hussein H, Kishen A. Local Immunomodulatory Effects of Intracanal Medications in Apical Periodontitis. J Endod. 2022 Apr;48(4):430-456. doi: 10.1016/j.joen.2022.01.003. Epub 2022 Jan 13.

    PubMed 35032538

  • Arias Z, Nizami MZI, Chen X, Chai X, Xu B, Kuang C, Omori K, Takashiba S. Recent Advances in Apical Periodontitis Treatment: A Narrative Review. Bioengineering (Basel). 2023 Apr 19;10(4):488. doi: 10.3390/bioengineering10040488.

    PubMed 37106675

Questions about this trial

What is this clinical trial studying?

A study testing Aloe vera gel and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Necrotic Teeth With Apical Periodontitis, run by Ain Shams University at 1 site in Egypt.

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 5 inclusion and 5 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 17 Sep 2026. 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 Egypt. 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?

To detect Aloe Vera effect on pro-inflammatory by detecting cytokine IL-β level (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07826091, which also lists 9 linked publications.

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 17 Sep 2026.

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