Infection PrimaryPhase 3NCT05657132
Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication
A Phase 3 study testing herbal intracanal medication paste and Meta paste in people with Infection Primary, run by Nahda University at 1 site in Egypt.
Trial summary
studying the antibacterial effect of Cosuts paste as an intracanal medication against Enterococcus faecalis that present in necrotic primary teeth Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection Primary
- What is being tested?
- herbal intracanal medication paste and Meta paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Aug 2021to 30 Dec 2022
- Phase
- Phase 3
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with clinically and radiologically diagnosed infected primary teeth in their mandibular arch.
- Teeth should be deeply carious, with a history of spontaneous pain and carious exposures with necrotic pulp was also be selected
- radiographic evidence of adequate alveolar bone support, and absence of internal or external resorption.
- tooth must be restorable.
Who cannot join
- vital tooth
- Non restorable teeth
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
NUB University
Cairo, Bani Suif
Ghada Salem, Ph.D, +201005144561, ghadamohamedalirana@hotmail.com
Mariem Elmansy, 01223355029, drmaryamelmansy@hotmail.com
About this study
Official title: Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication in Necrotic Primary Molars, a Randomized Control Trial
studying the antibacterial effect of Cosuts paste as an intracanal medication against Enterococcus faecalis that present in necrotic primary teeth
Read the detailed description
The children were randomly divided into two groups (I, II) Group I (N=12): using Costus-based paste as an intracanal medicament. Group II (N= 12): Calcium hydroxide iodoform paste (Metapex) as an intracanal medicament.
Procedure:
Access opening was started. then a swab was taken from the distal root canal with a dry paper point and transferred to a sterile test tube. The canals were filled with an intracanal medication according to the patient group. In group I, the canals was filled with a previously prepared Costus-based paste for one week, and In Group II, the canals were filled with Meta paste for one week. After 1 week, the paste was washed away from the canals then another swab was taken from the distal canal by a dry paper point as done before preoperatively.
The 2 swabs were transferred within 2 hours to the lab for bacterial culture and detection of enterococcus faecalis count.
- Conditions
- Infection Primary
- Being tested
- herbal intracanal medication paste, Meta paste
- Keywords
- infected primary molars, metapaste, herbal paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal intracanal medication pasteDrug
Also called herbal paste
study the effect of costus herbal paste on enterococcus faecalis bacteria
Meta pasteDrug
Also called control paste
compare the effect of Costus paste with meta paste in reducing the number of enterococcus faecalis
| Study group | Role | What they receive |
|---|---|---|
| Costus paste | Experimental | Costus paste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar Receives: Drug: herbal intracanal medication paste |
| metapaste | Active comparator | metapaste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar Receives: Drug: Meta paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial count
Colony forming unit
Measured: 1 weak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start19 Aug 2021
- Primary completion10 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection PrimaryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GHada Abdelwahab Ahmed, Nahda University
- Investigators
- Ghada Salem, Ph.D, Principal investigator, associate professor of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657132
- Sponsor's protocol ID
- 050622
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not to share IPD until publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication in Necrotic Primary Molars, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05657132
- Acronym / sponsor ID
- 050622
- Conditions
- Infection Primary
- Keywords
- infected primary molars, metapaste, herbal paste
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nahda UniversityUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 20 Dec 2022 (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.
studying the antibacterial effect of Cosuts paste as an intracanal medication against Enterococcus faecalis that present in necrotic primary teeth
Detailed description
The children were randomly divided into two groups (I, II) Group I (N=12): using Costus-based paste as an intracanal medicament. Group II (N= 12): Calcium hydroxide iodoform paste (Metapex) as an intracanal medicament.
Procedure:
Access opening was started. then a swab was taken from the distal root canal with a dry paper point and transferred to a sterile test tube. The canals were filled with an intracanal medication according to the patient group. In group I, the canals was filled with a previously prepared Costus-based paste for one week, and In Group II, the canals were filled with Meta paste for one week. After 1 week, the paste was washed away from the canals then another swab was taken from the distal canal by a dry paper point as done before preoperatively.
The 2 swabs were transferred within 2 hours to the lab for bacterial culture and detection of enterococcus faecalis count.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Costus paste | Experimental | Drug: herbal intracanal medication pasteCostus paste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar |
| metapaste | Active comparator | Drug: Meta pastemetapaste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with clinically and radiologically diagnosed infected primary teeth in their mandibular arch.
- Teeth should be deeply carious, with a history of spontaneous pain and carious exposures with necrotic pulp was also be selected
- radiographic evidence of adequate alveolar bone support, and absence of internal or external resorption.
- tooth must be restorable.
Key exclusion criteria (2 listed)
- vital tooth
- Non restorable 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 |
|---|---|---|
| herbal intracanal medication pasteAlso: herbal pastestudy the effect of costus herbal paste on enterococcus faecalis bacteria | Drug | Costus paste |
| Meta pasteAlso: control pastecompare the effect of Costus paste with meta paste in reducing the number of enterococcus faecalis | Drug | metapaste |
Primary outcome
Bacterial count
Time frame: 1 weak
Colony forming unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No. not to share IPD until publication
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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.
Ghada Salem, Ph.D principal investigator
associate professor of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing herbal intracanal medication paste and Meta paste in people with Infection Primary, run by Nahda 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 4 inclusion and 2 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 20 Dec 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ghada Salem, Ph.D (+201005144561, ghadamohamedalirana@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial count (time frame: 1 weak). 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 20 Dec 2022.