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Not yet recruitingNCT06755502Updated Mar 20, 2025

Garlic Oil As Root Filling Material in Primary Molars

An interventional study of Garlic oil and Calcium Hydroxide, Iodoform, paste in Irreversible Pulpitis (toothache), sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study summary

The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years.

the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex).

The group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.

Read the detailed description

This study is a randomized clinical trial (RCT), that aims compare the clinical and radio-graphic success of garlic oil mixed with zinc oxide, used as root canal filling material in primary molars in children aged from four to eight years, with the conventional root filling material, which is metapex.

02

Conditions studied

  • Irreversible Pulpitis (toothache)

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Keywords

  • RCT
  • garlic oil
  • natural remedies
  • primary molars
  • root canal filling material
03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's planned enrollment of 40 is below the median of 84 across 123 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis.
  2. Presence of sinus tract.
  3. Periapical bone swelling.
  4. Continuous bleeding after amputation of the coronal pulp tissue.
  5. No pulp tissue remains when the pulp chamber is accessed.
  6. Pus discharges from the canal.
  7. Radiographically, only primary molars with at least two-thirds of the root length.
  8. Presence of inter-radicular or periapical radiolucency.

Exclusion criteria

Exclusion Criteria:

  1. A tooth with internal root resorption will not be included. 2. Excessive tooth mobility beyond healing. 3. Carious perforation in the pulpal flour. 4. A tooth with a pathological lesion extending to the successor's tooth germ. 5. Non-restorable primary molars.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    garlic oil with zinc oxide group

    Combination Product: Garlic oil

  • Active comparator
    metapex group

    Drug: Calcium Hydroxide, Iodoform, paste

Interventions

  • Combination productGarlic oil

    garlic oil mixed with zinc oxid powder, as root canal filling material

  • DrugCalcium Hydroxide, Iodoform, paste

    Drug pages: Calcium Hydroxide · Iodoform

    Metapex as root canal filling materials

    Also known as: metapex

06

What researchers measure

Primary outcomes

  1. The clinical success rate

    The criteria of successful treatment, according to which the clinical evaluation will be done, will be "No abnormal mobility", "No sensitivity to percussion", and "No swelling"

    Time frame: 3, 6,9,and 12 months

  2. Radio-graphic success

    For the radiographic success, the evaluation criteria will be "Preoperative pathological inter-radicular and/or periapical radiolucency started to resolve, or remained the same size", "No new postoperative pathological radiolucency developed", and "No pathological internal or external root resorption"

    Time frame: 6, and 12 month.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2025; primary completion for Oct 2026, 14 months later.

Of 44 non-industry interventional studies with no phase under Toothache, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 14 months is above that.

Counting every sponsor, half of 45 studies reached it within 5 months; a quarter within 3 and three quarters within 12.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 25, 2024
First posted
Jan 1, 2025
StartEst.
Aug 8, 2025
Primary completionEst.
Oct 8, 2026
CompletionEst.
Nov 8, 2026
Last update
Mar 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06755502
Lead sponsor
Cairo University
Responsible party
Mennat Allah Ashraf Abd Elsabour Abd Elkareem (PhD degree student, Faculty of Dentistry, Cairo University., Cairo University) — Principal investigator
First posted
Jan 1, 2025
Start date
Aug 8, 2025 (estimated)
Primary completion
Oct 8, 2026 (estimated)
Completion
Nov 8, 2026 (estimated)
Last update
Mar 20, 2025

Study contacts

Mennat Allah A. A. Elkareem
Contact
mennatallah.ashraf@dentistry.cu.edu.eg
+20 1026022605

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Allyl sulfide

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