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Completed

NCT Number: NCT07826091

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

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.

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Ain shams university

Cairo, Abbasia, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

Aloe vera gel

Drug

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

Other names: aloe vera intra-canal paste

Calcium Hydroxide (Ca(OH)2) Intracanal Medication

Drug

<30% wt

Other names: Metapaste, CH

Primary outcomes

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

    Time frame: 14 days

    Detected using ELISA

Secondary outcomes

  1. inter-appointment incidence of pain using VAS

    Time frame: 24hours, 48hours post intracanal medication placement

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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