ClinicalTrials.gg
RecruitingNCT05860712Updated Aug 22, 2024

Evaluation of Antimicrobial, Post Operative Pain of Cinnamon Extract Versus Sodium Hypochlorite Irrigant Following Pulpectomy of Primary Teeth

An interventional study of Irrigation in Irreversible Pulpitis and Caries,Dental, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.

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

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 151 studies in Dental Caries by Cairo University — 41 open to participants now, 43 under way, none of them phase 3. Dental Caries · Cairo University.

Planned enrollment
99th of 120
26 · median 46
Started
2024
with 21 others
No phase
101 of 151
29 open now
Primary completion
2024-09
later than 2 of 42 live
Registered
92nd of 151
by date

Among the 151 studies in Dental Caries by Cairo University, this one is the 99th largest by planned enrollment of the 120 interventional ones that give a count, is one of 22 that started in 2024, is one of 101 with no phase, reaches primary completion later than 2 of the 42 other live ones, and was the 92nd registered.

Dental Caries

1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.

Browse Dental Caries studies →

Open to participants now

41 of the 151 studies in Dental Caries by Cairo University are open now, in 1 country. Recruiting first, the newest first:

35 more — sign in →

By country, each count listing its studies:

All 41 open studies →

Where they have run

Who these studies take

Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.

This study: 4 Years to 8 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 151 studies in Dental Caries by Cairo University, or all of them as a file.
02

Study summary

The aim of the study is to evaluate effectiveness of cinnamon extract versus sodium hypochlorite as root canal irrigant for in pulpectomy of primary teeth in reduction of bacterial count .

Read the detailed description

Preservation of primary teeth with non-vital pulp is a major problem in pediatric dentistry, as it is a poly-microbial and dominated by obligatory anaerobic bacteria. Regarding these case preferable treatment modality is pulpectomy . The objective of pulpectomy is complete removal of necrotic and irreversibly infected pulp of an affected tooth but due to limited ability of mechanical preparation to eliminate entrapped micro-organisms in the canal space owing to the tortuous and complex nature of the root canal system .Thus, the use of antimicrobial agents has been recommended as an adjunct to mechanical instrumentation in deciduous teeth . Due to potential side effects, safety concerns of synthetic drugs and cytotoxic reactions of commercial intra canal irrigants and their limited ability to eliminate bacteria from dentinal tubules . Finding the best irrigating solution for endodontic therapy in primary and permanent teeth is still a working progress .There is a growing interest in using sustainable products of natural origin as an alternative to commercially available industrial ones .Cinnamon , which has gained popularity in recent time due its antibacterial , antifungal , anti-inflammatory \& antiseptic activity . It has shown effectiveness against S. mutans and E. fecalis organisms . It is also known to show a wide spectrum of action on gram positive and gram negative bacteria .

03

Conditions studied

  • Irreversible Pulpitis
  • Caries,Dental

Browse trials for

Keywords

  • antimicrobial and post operative pain evaluation
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

  • Children:

    1. Aged 4 to 8, in good general health, and medically free.
    2. Cooperative patients who will comply to dental treatment .
    3. Parents provided with written .
    4. No previous history of antibiotics administration or last dose was taken from at least 2 weeks.
  • Teeth:

    1. Carious primary molars with irreversible pulpitis.
    2. Presence of localized swelling ,sinus and pain on percussion which indicate non vital pulp .
    3. Presence of periapical and furcation radiolucency .
    4. In periapical radiograph teeth have no more than 1/3 of root resorption.

Exclusion criteria

Exclusion Criteria:

  • Children:

    1. Children with medical, physical, or mental conditions.
    2. Severly Uncooperative children .
  • Teeth:

    1. Primary molars with any congenital anomalies.
    2. Teeth with un-restorable crowns .
    3. Root resorbtion more than half of the root.

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Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

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

Study arms

  • Active comparator
    Sodium hypochlorite Irrigation

    standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, and a sharp spoon excavator will remove pulpal tissues to the orifice level , the working lengths of root canals were estimated by apex locator and Cleaning and shaping of the root canals was done by rotary files .The pre - irrigation sample were collected after debridement of the radicular pulp tissues by a sterile paper point ,then Second microbial sample : The canals were irrigated with Sodium hypochlorite Irrigation (group A) .All the microbiological culturing procedures were carried out in the Microbiology and Immunology Department , the plates were examined and the colonies were directly counted using colony forming unit .

    Other: Irrigation

  • Sham comparator
    Cinnamon extract Irrigation

    standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, and a sharp spoon excavator will remove pulpal tissues to the orifice level , the working lengths of root canals were estimated by apex locator and Cleaning and shaping of the root canals was done by rotary files .The pre - irrigation sample were collected after debridement of the radicular pulp tissues by a sterile paper point ,then Second microbial sample : The canals were irrigated with cinnamon Irrigation (group B) . All the microbiological culturing procedures were carried out in the Microbiology and Immunology Department , the plates were examined and the colonies were directly counted using colony forming unit .

    Other: Irrigation

Interventions

  • OtherIrrigation

    Cinnamon to be prepared were mixed with 50% ethanol and this suspension was placed on the magnetic stirrer for 4 hours.Whitman's filter paper was used to obtain the filtrate which was then dried to obtain the extract. The extract was dried to evaporate the solvent to prevent the influence of extracting agent (ethanol) on the final extract. Cinnamon extract was obtained using cinnamon bark which was pulverized into medium coarse granules. The extracting agent and the procedure to obtain the final extract.These extracts were stored in dark coloured bottles at 4 degree Celsius until use.

06

What researchers measure

Primary outcomes

  1. Change in bacterial count.

    Quantitative.(Colony Forming Unit ) take sample by paper point before and after irrigation by control of interventional

    Time frame: Day 1

Secondary outcomes

  1. post operative pain evaluation

    four point facial pain intensity scoring system

    Time frame: 6,12,24,48,72 hour

07

Study locations

1 of 1 sites recruiting
08

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

Started Jan 2024 (actual). Primary completion is estimated for Sep 2024, 8 months after the start.

Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 8 months is below that.

Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.

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

Registered
May 6, 2023
First posted
May 16, 2023
StartActual
Jan 20, 2024
Primary completionEst.
Sep 20, 2024
CompletionEst.
Nov 22, 2024
Last update
Aug 22, 2024
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 Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05860712
Lead sponsor
Cairo University
Responsible party
Amany Hossam (Principle Investigator, Cairo University) — Principal investigator
First posted
May 16, 2023
Start date
Jan 20, 2024
Primary completion
Sep 20, 2024 (estimated)
Completion
Nov 22, 2024 (estimated)
Last update
Aug 22, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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