Bacterial Viability of Necrotic Pulp With Asymptomatic Apical PeriodontitisPhase 1NCT06291623
Molecular Analysis of Intracanal Microbes After Chemomechanical Procedure and Root Canal Medication: A Randomized Controlled Trial
A Phase 1 study testing Glycyrrhizin in people with Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to evaluate clinically the intracanal microbes at molecular level after using established root canal medicament Calcium hydroxide and potential root canal medicament Glycyrrhizin.and Decontamination Analysis of Controls samples. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis
- What is being tested?
- Glycyrrhizin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2022to 15 Jan 2024
- Phase
- Phase 1
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single-rooted teeth with a single canal, necrotic pulp (did not respond to sensitivity testing) and symptomatic apical periodontitis
- The age ranges from 19 to 60 years
- Exclusion Criteria:- Receiving antibiotic treatment within the preceding 3 months.
- Reporting systemic disease.
- Teeth that could not be isolated with rubber dam.
- Teeth with periodontal pockets deeper than 3 mm.
- Root fracture or badly decayed teeth.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate clinically the intracanal microbes at molecular level after using established root canal medicament Calcium hydroxide and potential root canal medicament Glycyrrhizin.and Decontamination Analysis of Controls samples.
Read the detailed description
Bacteria and their by-products are the main etiologic factors for pulpal and periapical diseases. The goals of endodontic treatment are to achieve complete disinfection and prevent reinfection in the root canal system and periapical tissues. Sterilization of root canals is limited by the presently available techniques, instruments, irrigants and intracanal medication. Thus, the focus should be on reducing intracanal bacterial populations to levels that are compatible with periapical tissue healing.Because root canal medicaments can come in contact with periapical tissue, in addition to having good antibacterial ability, they must also be biocompatible. In selecting root canal medicaments, it is necessary to consider their therapeutic benefits against their potential cytotoxic effects. Ideal root canal medicaments should have strong antibacterial properties and minimal cytotoxic effect on the host tissues.Globally, plants and their products are used for improving health. Plant extracts contain bioactive compounds like polyphenols, flavonoids, and many other compounds and chemical substances which play important roles to treat diseases. Due to health benefits, phytochemicals from plants generate a lot of interest, demanding further scientific evaluation.Glycyrrhiza which is known as licorice belonging to the Fabaceae, is native to southern Europe and parts of Asia . Glycyrrhizin has been labelled Generally Recognized as Safe (GRAS) by United States Food and Drug Administration (FDA) and has been considered safe for human consumption.Licorice roots have been used as a remedy for cough, laxative, menopausal hot flashes, peptic ulcer, and viral diseases . Licorice contains more than 20 triterpenoids and nearly 300 flavonoids. Among them, glycyrrhizin, 18 β-glycyrrhetinic acid, liquiritigenin, licochalcone A, licochalcone E and glabridin are the main active components which possess antimicrobial, antioxidant and anti-inflammatory activities.Evaluation of intra canal Bacterial levels and species before and after Chemomechanical procedures have been extensively explored by both culture (phenotype) and molecular techniques (genotype) . The latter became choice methods to assess persistent endodontic bacteria because of their high sensitivity and the ability to detect as-yet-uncultivated/difficult-to-culture bacteria.
- Being tested
- Glycyrrhizin
- Keywords
- Dna , Rna extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycyrrhizinDrug
Also called Calcium hydroxide
used as intracanal medication for one week
| Study group | Role | What they receive |
|---|---|---|
| Pre disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate. | Experimental | sample was taken before pre disinfection protocol (30% H2O2, followed by 2.5% NaOCl) NaOCl will be inactivated with 5% sodium thiosulfate. Receives: Drug: Glycyrrhizin |
| Post disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate. | Experimental | sample was taken after pre disinfection protocol, to check the sterility of the disinfected tooth surface and access Receives: Drug: Glycyrrhizin |
| Group 1 (n = 10): Ca(OH)2 | Experimental | 3 samples was taken before and after the treatment. Sample 1 was taken before Chemomechanical procedures Sample 2 was taken immediately after Chemomechanical procedures, intracanal medication was placed for 1 week Sample 3 was taken immediately after intracanal medication was removed Receives: Drug: Glycyrrhizin |
| Group 2 (n = 10): Glycyrrhizin | Experimental | 3 samples was taken before and after the treatment. Sample 1 was taken before Chemomechanical procedures Sample 2 was taken immediately after Chemomechanical procedures, intracanal medication was placed for 1 week Sample 3 was taken immediately after intracanal medication was removed Receives: Drug: Glycyrrhizin |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimizing of viable bacteria which showed by Real time PCR
viable bacteria minimizing of Necrotic single canal with asymptomatic apical periodontitis
Measured: after one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 May 2022
- Primary completion20 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial Viability of Necrotic Pulp With Asymptomatic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Mansoura 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291623
- Sponsor's protocol ID
- Molecular Analysis
- Status last verified
- Jan 2024
- First submitted
- 14 Feb 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khaleefah OT, El-Baz AM, Gomaa MA, Badr AE. Molecular analysis of intracanal microbial reduction to compare the effectiveness of glycyrrhizin and calcium hydroxide as intracanal medications: a randomised controlled trial. BMC Oral Health. 2026 Mar 11;26(1):731. doi: 10.1186/s12903-026-07906-6.
PubMed 41814304
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Intracanal Microbes After Chemomechanical Procedure and Root Canal Medication: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06291623
- Acronym / sponsor ID
- Molecular Analysis
- Keywords
- Dna , Rna extraction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 4 Mar 2024 (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.
This study aimed to evaluate clinically the intracanal microbes at molecular level after using established root canal medicament Calcium hydroxide and potential root canal medicament Glycyrrhizin.and Decontamination Analysis of Controls samples.
Detailed description
Bacteria and their by-products are the main etiologic factors for pulpal and periapical diseases. The goals of endodontic treatment are to achieve complete disinfection and prevent reinfection in the root canal system and periapical tissues. Sterilization of root canals is limited by the presently available techniques, instruments, irrigants and intracanal medication. Thus, the focus should be on reducing intracanal bacterial populations to levels that are compatible with periapical tissue healing.Because root canal medicaments can come in contact with periapical tissue, in addition to having good antibacterial ability, they must also be biocompatible. In selecting root canal medicaments, it is necessary to consider their therapeutic benefits against their potential cytotoxic effects. Ideal root canal medicaments should have strong antibacterial properties and minimal cytotoxic effect on the host tissues.Globally, plants and their products are used for improving health. Plant extracts contain bioactive compounds like polyphenols, flavonoids, and many other compounds and chemical substances which play important roles to treat diseases. Due to health benefits, phytochemicals from plants generate a lot of interest, demanding further scientific evaluation.Glycyrrhiza which is known as licorice belonging to the Fabaceae, is native to southern Europe and parts of Asia . Glycyrrhizin has been labelled Generally Recognized as Safe (GRAS) by United States Food and Drug Administration (FDA) and has been considered safe for human consumption.Licorice roots have been used as a remedy for cough, laxative, menopausal hot flashes, peptic ulcer, and viral diseases . Licorice contains more than 20 triterpenoids and nearly 300 flavonoids. Among them, glycyrrhizin, 18 β-glycyrrhetinic acid, liquiritigenin, licochalcone A, licochalcone E and glabridin are the main active components which possess antimicrobial, antioxidant and anti-inflammatory activities.Evaluation of intra canal Bacterial levels and species before and after Chemomechanical procedures have been extensively explored by both culture (phenotype) and molecular techniques (genotype) . The latter became choice methods to assess persistent endodontic bacteria because of their high sensitivity and the ability to detect as-yet-uncultivated/difficult-to-culture bacteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate. | Experimental | Drug: Glycyrrhizinsample was taken before pre disinfection protocol (30% H2O2, followed by 2.5% NaOCl) NaOCl will be inactivated with 5% sodium thiosulfate. |
| Post disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate. | Experimental | Drug: Glycyrrhizinsample was taken after pre disinfection protocol, to check the sterility of the disinfected tooth surface and access |
| Group 1 (n = 10): Ca(OH)2 | Experimental | Drug: Glycyrrhizin3 samples was taken before and after the treatment. Sample 1 was taken before Chemomechanical procedures Sample 2 was taken immediately after Chemomechanical procedures, intracanal medication was placed for 1 week Sample 3 was taken immediately after intracanal medication was removed |
| Group 2 (n = 10): Glycyrrhizin | Experimental | Drug: Glycyrrhizin3 samples was taken before and after the treatment. Sample 1 was taken before Chemomechanical procedures Sample 2 was taken immediately after Chemomechanical procedures, intracanal medication was placed for 1 week Sample 3 was taken immediately after intracanal medication was removed |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Single-rooted teeth with a single canal, necrotic pulp (did not respond to sensitivity testing) and symptomatic apical periodontitis
- The age ranges from 19 to 60 years
- Exclusion Criteria:- Receiving antibiotic treatment within the preceding 3 months.
- Reporting systemic disease.
- Teeth that could not be isolated with rubber dam.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GlycyrrhizinAlso: Calcium hydroxideused as intracanal medication for one week | Drug | Group 1 (n = 10): Ca(OH)2, Group 2 (n = 10): Glycyrrhizin, Post disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate., Pre disinfection (30% H2O2, followed by 2.5% NaOCl) NaOCl inactivated with 5% sodium thiosulfate. |
Primary outcome
minimizing of viable bacteria which showed by Real time PCR
Time frame: after one week
viable bacteria minimizing of Necrotic single canal with asymptomatic apical periodontitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 41814304Khaleefah OT, El-Baz AM, Gomaa MA, Badr AE. Molecular analysis of intracanal microbial reduction to compare the effectiveness of glycyrrhizin and calcium hydroxide as intracanal medications: a randomised controlled trial. BMC Oral Health. 2026 Mar 11;26(1):731. doi: 10.1186/s12903-026-07906-6.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycyrrhizin in people with Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis, run by Mansoura 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 28 Aug 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minimizing of viable bacteria which showed by Real time PCR (time frame: after one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291623, which also lists 1 linked publication.
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 28 Aug 2025.