Necrotic PulpNCT03588351
Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth
A study testing chitosan nanoparticles gel, chitosan gel and chlorhexidine gluconate in people with Necrotic Pulp, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of the present study is to assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticles ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- chitosan nanoparticles gel, chitosan gel and chlorhexidine gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 30 Aug 2018
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Apparently healthy children.
- Age 4-7 years
- Children should have at least one non vital and restorable mandibular molar .
- Cooperative children.
- Children that did not take any antibiotic for at least one month before sample collection
Who cannot join
- Medically compromised children.
- Children under antibiotic therapy.
- Non restorable molars.
- Root resorption more then half of the root length.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth: An In-vivo Study
Aim of the present study is to assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticles ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars
Read the detailed description
Primary teeth with necrotic pulp are a common problem in pediatric dentistry especially in very young children before first permanent molar eruption. Early loss of primary teeth can cause a number of problems, including space loss, esthetic, phonetic or functional problems. However, some of the infected primary teeth can remain functional until the exfoliation via endodontic treatment. Pulpectomy is indicated in primary teeth with necrotic pulp in which the radicular tissue exhibits clinical signs of chronic inflammation.
The primary objective of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues. One of the most important aims of pulpectomy treatment is to eradicate or substantially reduce the microbial load in the root canal system. Currently, insignificant data is available regarding the identification of microbiota in deciduous teeth with pulp necrosis and periapical pathosis. However, documentation exists in relation to the polymicrobial nature of microbes predominated by anaerobes in the root canals of deciduous teeth with necrotic pulp and periapical lesions similar to permanent teeth.
Various microorganisms isolated from infected root canals include Streptococci, Staphylo-coccus, Diptheroids, Peptostreptococcus, Lactoba-cilli, Propionibacterium, Actinomyces, Bacteroides, Fusobacterium etc.
The commonly isolated facultative anaerobes microorganisms from primary root canals, Enterococcus faecalis was isolated in 30% of cases, Escherichia coli in 28.4%, Staphylococcus aureus in 25%, α-hemolytic Streptococci in 15% and Proteus mirabilis in 1.6% of cases.
- faecalis is a persistent organism that plays a major role in the etiology of persistent periradicular lesions after root canal treatment. It is commonly found in high percentage of root canal failures and is able to survive in the root canal as a single organism or as a major component of the flora.
Therefore, intracanal medication was advocated to further reduce bacteria in the root canal system and reduce the failure of root canal treatment. Thus, chemomechanical debridement using intracanal medicament and irrigants is essential to eliminate these microorganisms, and their by-products that remained in the pulpal space which was inaccessible to systemic antibiotics and root canal instrumentations.
Chlorhexidine (CHX) usually used as a root canal irrigant especially in primary molars owing to its biocompatibility, substantivity and wide antimicrobial activity.
Recently there is an increase interest in using natural product in medical fields. Chitosan is a natural and non-toxic polysaccharide with many biological applications, particularly as an antimicrobial agent. Chitosan nanoparticle is a bioactive and environment friendly material with unique physicochemical properties .
To date, none of the studies has consistently investigated the effects of Chitosan as new alternative when used as root canal medicament in primary teeth. Therefore the present study aimed to compare in vivo susceptibility of root canal bacteria to chitosan, chitosan nanoparticals, and chlorhexidine gluconate as intra canal medicaments in necrotic primary molars.
- Conditions
- Necrotic Pulp
- Being tested
- chitosan nanoparticles gel, chitosan gel, chlorhexidine gluconate
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chitosan nanoparticles gelDrug
Also called CSNPs
intracanal medicament
chitosan gelDrug
Also called CS
intracanal medicament
chlorhexidine gluconateDrug
Also called CHX
intracanal medicament
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine gluconate | Active comparator | GROUP I: - 15 teeth will be treated with specially prepared gel containing chlorhexidine gluconate as intracanal medicament . Receives: Drug: chlorhexidine gluconate |
| chitosan nanoparticles gel | Experimental | GROUP II: - 15 teeth will be treated with specially prepared gel containing chitosan nanoparticles that ready to use as intracanal medicament. Receives: Drug: chitosan nanoparticles gel |
| chitosan gel | Experimental | Group III: 15teeth will be treated with specially prepared gell containing chitosan that ready to use as intra medicament . Receives: Drug: chitosan gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticals ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars.
antibacterial effect of Chlorhexidine Gluconate, Chitosan,Chitosan Nanoparticl on necrotic primary tooth
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jan 2018
- Primary completion15 Aug 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Abozed, Ain Shams University
- Investigators
- Marwa A Abozed, BDSC, Principal investigator, Faculty of Dentistry Ain shams University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588351
- Sponsor's protocol ID
- PED-3-17
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth: An In-vivo Study
- ClinicalTrials.gov ID
- NCT03588351
- Acronym / sponsor ID
- PED-3-17
- Conditions
- Necrotic Pulp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Aug 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 17 Jul 2018 (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.
Aim of the present study is to assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticles ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars
Detailed description
Primary teeth with necrotic pulp are a common problem in pediatric dentistry especially in very young children before first permanent molar eruption. Early loss of primary teeth can cause a number of problems, including space loss, esthetic, phonetic or functional problems. However, some of the infected primary teeth can remain functional until the exfoliation via endodontic treatment. Pulpectomy is indicated in primary teeth with necrotic pulp in which the radicular tissue exhibits clinical signs of chronic inflammation.
The primary objective of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues. One of the most important aims of pulpectomy treatment is to eradicate or substantially reduce the microbial load in the root canal system. Currently, insignificant data is available regarding the identification of microbiota in deciduous teeth with pulp necrosis and periapical pathosis. However, documentation exists in relation to the polymicrobial nature of microbes predominated by anaerobes in the root canals of deciduous teeth with necrotic pulp and periapical lesions similar to permanent teeth.
Various microorganisms isolated from infected root canals include Streptococci, Staphylo-coccus, Diptheroids, Peptostreptococcus, Lactoba-cilli, Propionibacterium, Actinomyces, Bacteroides, Fusobacterium etc.
The commonly isolated facultative anaerobes microorganisms from primary root canals, Enterococcus faecalis was isolated in 30% of cases, Escherichia coli in 28.4%, Staphylococcus aureus in 25%, α-hemolytic Streptococci in 15% and Proteus mirabilis in 1.6% of cases.
- faecalis is a persistent organism that plays a major role in the etiology of persistent periradicular lesions after root canal treatment. It is commonly found in high percentage of root canal failures and is able to survive in the root canal as a single organism or as a major component of the flora.
Therefore, intracanal medication was advocated to further reduce bacteria in the root canal system and reduce the failure of root canal treatment. Thus, chemomechanical debridement using intracanal medicament and irrigants is essential to eliminate these microorganisms, and their by-products that remained in the pulpal space which was inaccessible to systemic antibiotics and root canal instrumentations.
Chlorhexidine (CHX) usually used as a root canal irrigant especially in primary molars owing to its biocompatibility, substantivity and wide antimicrobial activity.
Recently there is an increase interest in using natural product in medical fields. Chitosan is a natural and non-toxic polysaccharide with many biological applications, particularly as an antimicrobial agent. Chitosan nanoparticle is a bioactive and environment friendly material with unique physicochemical properties .
To date, none of the studies has consistently investigated the effects of Chitosan as new alternative when used as root canal medicament in primary teeth. Therefore the present study aimed to compare in vivo susceptibility of root canal bacteria to chitosan, chitosan nanoparticals, and chlorhexidine gluconate as intra canal medicaments in necrotic primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine gluconate | Active comparator | Drug: chlorhexidine gluconateGROUP I: - 15 teeth will be treated with specially prepared gel containing chlorhexidine gluconate as intracanal medicament . |
| chitosan nanoparticles gel | Experimental | Drug: chitosan nanoparticles gelGROUP II: - 15 teeth will be treated with specially prepared gel containing chitosan nanoparticles that ready to use as intracanal medicament. |
| chitosan gel | Experimental | Drug: chitosan gelGroup III: 15teeth will be treated with specially prepared gell containing chitosan that ready to use as intra medicament . |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Apparently healthy children.
- Age 4-7 years
- Children should have at least one non vital and restorable mandibular molar .
- Cooperative children.
- Children that did not take any antibiotic for at least one month before sample collection
Key exclusion criteria (4 listed)
- Medically compromised children.
- Children under antibiotic therapy.
- Non restorable molars.
- Root resorption more then half of the root length.
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 |
|---|---|---|
| chitosan nanoparticles gelAlso: CSNPsintracanal medicament | Drug | chitosan nanoparticles gel |
| chitosan gelAlso: CSintracanal medicament | Drug | chitosan gel |
| chlorhexidine gluconateAlso: CHXintracanal medicament | Drug | chlorhexidine gluconate |
Primary outcome
assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticals ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars.
Time frame: 3 month
antibacterial effect of Chlorhexidine Gluconate, Chitosan,Chitosan Nanoparticl on necrotic primary tooth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Related trials for Necrotic Pulp
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
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.
Marwa A Abozed, BDSC principal investigator
Faculty of Dentistry Ain shams University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chitosan nanoparticles gel, chitosan gel and chlorhexidine gluconate in people with Necrotic Pulp, run by Ain Shams 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 5 inclusion and 4 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 17 Jul 2018. 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.
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?
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?
assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticals ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars. (time frame: 3 month). 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 17 Jul 2018.