Resorption of Tooth or RootPhase 3LSTRNCT05079802
Clinical & Radiographic Evaluation of LSTR in Non-vital Primary Molars Using Two Different Vehicles
A Phase 3 study testing Double antibiotic paste mixed with chitosan nanoparticles and Double antibiotic paste mixed with propylene glycol in people with Resorption of Tooth or Root, run by Ain Shams University.
Trial summary
LSTR will be done for primary teeth with significant root resorption needing non-vital pulp therapy to save such teeth for up to 12 months. The first part will be in vitro study to compare the antimicrobial effect of double antibiotic paste mixed with chitosan nanoparticle vs double antibiotic paste mixed with… Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Resorption of Tooth or Root
- What is being tested?
- Double antibiotic paste mixed with chitosan nanoparticles and Double antibiotic paste mixed with propylene glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Mar 2024
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1-Non-vital primary molars
- With root resorption more than 1 mm that needs to be retained a tooth for up to 12 months that otherwise would be extracted
- Without mobility up to grade I mobility.
Who cannot join
- Non-vital primary molars
- With perforation into the bifurcation.
- Badly broken down.
- With no root resorption.
- With excessive bone loss in furcation area involving underlying tooth germ.
- Nearing exfoliation.
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- Participants that
- Have previous history of allergy to the antibiotics used in the study.
- Their caregivers do not oblige to signing the informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair in Non-vital Primary Molars Using Double Antibiotic Paste With Two Different Vehicles (Randomized Clinical Trial and In Vitro Study)
LSTR will be done for primary teeth with significant root resorption needing non-vital pulp therapy to save such teeth for up to 12 months. The first part will be in vitro study to compare the antimicrobial effect of double antibiotic paste mixed with chitosan nanoparticle vs double antibiotic paste mixed with propylene glycol. The second part will be randomized clinical trial comparing the clinical and radiographic success of LSTR in study group where double antibiotic mix is mixed with chitosan nanoparticles and control group where double antibiotic paste is mixed with propylene glycol .
Read the detailed description
Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair in Non-vital Primary Molars Using Double Antibiotic Paste with Two Different Vehicles (Randomized Clinical Trial and In Vitro Study)
Introduction:
Healthy primary teeth are important for speech, mastication and to maintain the space for their permanent successors developing in the jaw underneath. Teeth with infected root canals, particularly those in which the infection has reached the peri-radicular tissues, are a common problem in the primary dentition. A relatively new biologic approach, lesion sterilization and tissue repair therapy (LSTR) was introduced. It was modified from 3 mix 1:1:1 metronidazole, ciprofloxacin and minocycline to double mix where 1:1 metronidazole and ciprofloxacin are mixed with propylene glycol. It is indicated for primary teeth with significant root resorption (external resorption greater than 1 mm and/ or internal resorption) needing non-vital pulp therapy. It is also indicated when the clinician decides not to extract the tooth with significant preoperative root resorption, LSTR should be the choice over pulpectomy to save such teeth for up to 12 months. Chitosan it is a natural nontoxic, biocompatible, biodegradable polysaccharide with broad antibacterial spectrum (covering gram-negative and gram-positive bacteria as well as fungi), and it has antioxidant and antitumor properties, also it has the ability to form film and gel. Chitosan and chitosan nanoparticle can be used as a vehicle for incorporating natural or chemical antimicrobial agents, however, chitosan nanoparticles exhibit a higher antimicrobial activity than chitosan. Also, chitosan nanoparticles have better absorption and penetration into dentinal tubules
Aim of Study:
- To evaluate the clinical and radiographic outcomes of using double antibiotic paste mixed with chitosan nanoparticles gel vs. double antibiotic paste mixed with propylene glycol in lesion sterilization and tissue repair in non-vital primary molars.
- Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application.
- Comparing the antibacterial effect of double antibiotic paste mixed with chitosan nanoparticles gel vs. that mixed with propylene glycol in vitro.
Methodology:
- In Vitro Microbiological Study Before the initiation of the clinical trial, an in vitro study will be carried out. A pilot study to assess the antimicrobial effect of double antibiotic paste mixed with a vehicle of chitosan nanoparticles gel of 2 different concentrations (0.3% and 0.5%) in order to determine which is the better concentration to be used in the lesion sterilization and tissue repair. A microbiological study will be carried out to compare the antimicrobial effect of double antibiotic paste mixed with the better concentration of chitosan nanoparticles gel according to the pilot study and double antibiotic paste mixed with propylene glycol. Sample size n=14, each group n=7. Procedures: A swab will be taken from non-vital primary molars with a paper point and it will be inserted in a suitable transporting medium and cultivated in a suitable medium and different bacterial strains will be identified. The strains will then be isolated and cultivated in suitable media. Materials under investigation will be added to identify the inhibition zones diameters.
- In Vivo Study
A randomized controlled trial, with 1:1 allocation ratio to either study group (group 1) or control group (group 2). Participants will be medically free children, in the age group 4-7 years, having non-vital primary molars with root resorption more than 1 mm that needs to be retained a tooth for up to 12 months that otherwise would be extracted. Sample size: n=36 molars, (group1) n=18 molars where LSTR will be performed with double antibiotic paste mixed with chitosan nanoparticles gel and (group 2) n=18 molars here LSTR will be performed with double antibiotic paste mixed with propylene glycol.
Procedures:
Caries will be removed with a sterile large round high-speed then pulpotomy will be performed and coronal pulp tissue will be removed using a sterile small sharp excavator, followed by irrigation with 1% sodium hypochlorite. Dryness will be done then double antibiotic will be mixed with chitosan nanoparticles gel until a creamy mix is formed then the mix will be placed in the pulp chamber for (group 1), while double antibiotic will be mixed with propylene glycol until a creamy mix is formed, then the mix will be placed in the pulp chamber for the (group 2). The glass ionomer will be injected to fill the pulp chamber and finally the tooth will be restored with a stainless-steel crown. Follow up will be for one year with recall visits at 1, 3, 6 and 12 months.
Clinical outcome: Reduction/absence of pain, no abnormal mobility/ swelling or abscess.
Radiographic outcomes: Decrease or resolution in interradicular radiolucency and decrease/absence of internal resorption.
- Conditions
- Resorption of Tooth or Root
- Being tested
- Double antibiotic paste mixed with chitosan nanoparticles, Double antibiotic paste mixed with propylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double antibiotic paste mixed with chitosan nanoparticlesDrug
Also called DAP mixed with CHNPs
Lesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with chitosan nanoparticles gel
Double antibiotic paste mixed with propylene glycolDrug
Also called DAP mixed with PG
Lesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with propylene glycol
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | study group Receives: Drug: Double antibiotic paste mixed with chitosan nanoparticles |
| Group 2 | Other | control group Receives: Drug: Double antibiotic paste mixed with propylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes through clinical examination
No pain. No abnormal mobility. No swelling
Measured: Follow up will be for one year with recall visits at 1, 3, 6 and 12 months
Radiographic outcomes by comparing pre and post treatment radiographic pathologic radiolucent area/s size/s
Decrease in size / absence of interradicular radiolucency. Decrease in size /absence of internal resorption.
Measured: Follow up will be for one year with recall visits at 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resorption of Tooth or RootStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abdel Halim, Ain Shams University
- Investigators
- Olaa Abdel Geleel, PhD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079802
- Sponsor's protocol ID
- PED21-7D
- Acronym
- LSTR
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair in Non-vital Primary Molars Using Double Antibiotic Paste With Two Different Vehicles (Randomized Clinical Trial and In Vitro Study)
- ClinicalTrials.gov ID
- NCT05079802
- Acronym / sponsor ID
- LSTR / PED21-7D
- Conditions
- Resorption of Tooth or Root
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 15 Oct 2021 (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.
LSTR will be done for primary teeth with significant root resorption needing non-vital pulp therapy to save such teeth for up to 12 months. The first part will be in vitro study to compare the antimicrobial effect of double antibiotic paste mixed with chitosan nanoparticle vs double antibiotic paste mixed with propylene glycol. The second part will be randomized clinical trial comparing the clinical and radiographic success of LSTR in study group where double antibiotic mix is mixed with chitosan nanoparticles and control group where double antibiotic paste is mixed with propylene glycol .
Detailed description
Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair in Non-vital Primary Molars Using Double Antibiotic Paste with Two Different Vehicles (Randomized Clinical Trial and In Vitro Study)
Introduction:
Healthy primary teeth are important for speech, mastication and to maintain the space for their permanent successors developing in the jaw underneath. Teeth with infected root canals, particularly those in which the infection has reached the peri-radicular tissues, are a common problem in the primary dentition. A relatively new biologic approach, lesion sterilization and tissue repair therapy (LSTR) was introduced. It was modified from 3 mix 1:1:1 metronidazole, ciprofloxacin and minocycline to double mix where 1:1 metronidazole and ciprofloxacin are mixed with propylene glycol. It is indicated for primary teeth with significant root resorption (external resorption greater than 1 mm and/ or internal resorption) needing non-vital pulp therapy. It is also indicated when the clinician decides not to extract the tooth with significant preoperative root resorption, LSTR should be the choice over pulpectomy to save such teeth for up to 12 months. Chitosan it is a natural nontoxic, biocompatible, biodegradable polysaccharide with broad antibacterial spectrum (covering gram-negative and gram-positive bacteria as well as fungi), and it has antioxidant and antitumor properties, also it has the ability to form film and gel. Chitosan and chitosan nanoparticle can be used as a vehicle for incorporating natural or chemical antimicrobial agents, however, chitosan nanoparticles exhibit a higher antimicrobial activity than chitosan. Also, chitosan nanoparticles have better absorption and penetration into dentinal tubules
Aim of Study:
- To evaluate the clinical and radiographic outcomes of using double antibiotic paste mixed with chitosan nanoparticles gel vs. double antibiotic paste mixed with propylene glycol in lesion sterilization and tissue repair in non-vital primary molars.
- Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application.
- Comparing the antibacterial effect of double antibiotic paste mixed with chitosan nanoparticles gel vs. that mixed with propylene glycol in vitro.
Methodology:
- In Vitro Microbiological Study Before the initiation of the clinical trial, an in vitro study will be carried out. A pilot study to assess the antimicrobial effect of double antibiotic paste mixed with a vehicle of chitosan nanoparticles gel of 2 different concentrations (0.3% and 0.5%) in order to determine which is the better concentration to be used in the lesion sterilization and tissue repair. A microbiological study will be carried out to compare the antimicrobial effect of double antibiotic paste mixed with the better concentration of chitosan nanoparticles gel according to the pilot study and double antibiotic paste mixed with propylene glycol. Sample size n=14, each group n=7. Procedures: A swab will be taken from non-vital primary molars with a paper point and it will be inserted in a suitable transporting medium and cultivated in a suitable medium and different bacterial strains will be identified. The strains will then be isolated and cultivated in suitable media. Materials under investigation will be added to identify the inhibition zones diameters.
- In Vivo Study
A randomized controlled trial, with 1:1 allocation ratio to either study group (group 1) or control group (group 2). Participants will be medically free children, in the age group 4-7 years, having non-vital primary molars with root resorption more than 1 mm that needs to be retained a tooth for up to 12 months that otherwise would be extracted. Sample size: n=36 molars, (group1) n=18 molars where LSTR will be performed with double antibiotic paste mixed with chitosan nanoparticles gel and (group 2) n=18 molars here LSTR will be performed with double antibiotic paste mixed with propylene glycol.
Procedures:
Caries will be removed with a sterile large round high-speed then pulpotomy will be performed and coronal pulp tissue will be removed using a sterile small sharp excavator, followed by irrigation with 1% sodium hypochlorite. Dryness will be done then double antibiotic will be mixed with chitosan nanoparticles gel until a creamy mix is formed then the mix will be placed in the pulp chamber for (group 1), while double antibiotic will be mixed with propylene glycol until a creamy mix is formed, then the mix will be placed in the pulp chamber for the (group 2). The glass ionomer will be injected to fill the pulp chamber and finally the tooth will be restored with a stainless-steel crown. Follow up will be for one year with recall visits at 1, 3, 6 and 12 months.
Clinical outcome: Reduction/absence of pain, no abnormal mobility/ swelling or abscess.
Radiographic outcomes: Decrease or resolution in interradicular radiolucency and decrease/absence of internal resorption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Double antibiotic paste mixed with chitosan nanoparticlesstudy group |
| Group 2 | Other | Drug: Double antibiotic paste mixed with propylene glycolcontrol group |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1-Non-vital primary molars
- With root resorption more than 1 mm that needs to be retained a tooth for up to 12 months that otherwise would be extracted
- Without mobility up to grade I mobility.
Key exclusion criteria (9 listed)
- Non-vital primary molars
- Participants that
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 |
|---|---|---|
| Double antibiotic paste mixed with chitosan nanoparticlesAlso: DAP mixed with CHNPsLesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with chitosan nanoparticles gel | Drug | Group 1 |
| Double antibiotic paste mixed with propylene glycolAlso: DAP mixed with PGLesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with propylene glycol | Drug | Group 2 |
Primary outcome
Clinical outcomes through clinical examination
Time frame: Follow up will be for one year with recall visits at 1, 3, 6 and 12 months
No pain. No abnormal mobility. No swelling
Radiographic outcomes by comparing pre and post treatment radiographic pathologic radiolucent area/s size/s
Time frame: Follow up will be for one year with recall visits at 1, 3, 6 and 12 months
Decrease in size / absence of interradicular radiolucency. Decrease in size /absence of internal resorption.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No
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.
Olaa Abdel Geleel, PhD study chair
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Double antibiotic paste mixed with chitosan nanoparticles and Double antibiotic paste mixed with propylene glycol in people with Resorption of Tooth or Root, run by Ain Shams University.
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 3 inclusion and 9 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 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Dina AH Ghaneya, MS (01006263615 ext. 002, dina.abdelhaleem88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes through clinical examination (time frame: Follow up will be for one year with recall visits at 1, 3, 6 and 12 months). The study lists 2 primary outcomes in all. 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 8 Nov 2021.