Irreversible PulpitisNCT05860712
Evaluation of Antimicrobial, Post Operative Pain of Cinnamon Extract Versus Sodium Hypochlorite Irrigant Following Pulpectomy of Primary Teeth
A study testing Irrigation in people with Irreversible Pulpitis and Caries,Dental, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Caries,Dental
- What is being tested?
- Irrigation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 22 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- Aged 4 to 8, in good general health, and medically free.
- Cooperative patients who will comply to dental treatment .
- Parents provided with written informed consent.
- No previous history of antibiotics administration or last dose was taken from at least 2 weeks.
- Teeth:
Show all 10Show fewer
- Carious primary molars with irreversible pulpitis.
- Presence of localized swelling ,sinus and pain on percussion which indicate non vital pulp .
- Presence of periapical and furcation radiolucency .
- In periapical radiograph teeth have no more than 1/3 of root resorption.
Who cannot join
- Children:
- Children with medical, physical, or mental conditions.
- Severly Uncooperative children .
- Teeth:
- Primary molars with any congenital anomalies.
- Teeth with un-restorable crowns .
- Root resorbtion more than half of the root.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
Amany H Hossam eldeen, M.sc, 01143416770, amany-ibrahim@dentistry.cu.edu.eg
Yossra M Mohamed, Phd, 01273335144, yousra.mohamed@dentistry.cu.edu.eg
About this study
Official title: Evaluation Of Antimicrobial Potency Of A Novel Cinnamon Extract Irrigant Versus Sodium Hypochlorite Irrigant Following Pulpectomy Of Primary Teeth . (A Randomized Clinical Trial)
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 .
- Conditions
- Irreversible Pulpitis, Caries,Dental
- Being tested
- Irrigation
- Keywords
- antimicrobial and post operative pain evaluation
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrrigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium hypochlorite Irrigation | Active comparator | 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 . Receives: Other: Irrigation |
| Cinnamon extract Irrigation | Sham comparator | 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 . Receives: Other: Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bacterial count.
Quantitative.(Colony Forming Unit ) take sample by paper point before and after irrigation by control of interventional
Measured: Day 1
Secondary outcomes (1)
post operative pain evaluation
four point facial pain intensity scoring system
Measured: 6,12,24,48,72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start20 Jan 2024
- Primary completion20 Sep 2024 (estimated)
- Study completion22 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hossam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860712
- Sponsor's protocol ID
- 17279
- Status last verified
- Aug 2024
- First submitted
- 6 May 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Antimicrobial Potency Of A Novel Cinnamon Extract Irrigant Versus Sodium Hypochlorite Irrigant Following Pulpectomy Of Primary Teeth . (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05860712
- Acronym / sponsor ID
- 17279
- Conditions
- Irreversible Pulpitis, Caries,Dental
- Keywords
- antimicrobial and post operative pain evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 22 Nov 2024 (estimated)
- First posted
- 16 May 2023 (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.
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 .
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium hypochlorite Irrigation | Active comparator | Other: Irrigationstandardized 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 . |
| Cinnamon extract Irrigation | Sham comparator | Other: Irrigationstandardized 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 . |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children:
- Teeth:
Key exclusion criteria (8 listed)
- Children:
- Teeth:
- -
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 |
|---|---|---|
| IrrigationCinnamon 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. | Other | Cinnamon extract Irrigation, Sodium hypochlorite Irrigation |
Primary outcome
Change in bacterial count.
Time frame: Day 1
Quantitative.(Colony Forming Unit ) take sample by paper point before and after irrigation by control of interventional
1 secondary outcome
post operative pain evaluation
Time frame: 6,12,24,48,72 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation in people with Irreversible Pulpitis and Caries,Dental, run by Cairo 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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bacterial count. (time frame: Day 1). 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 22 Aug 2024.