Pulpal NecrosisNCT06506526
Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
A study testing Sodium hypochlorite irrigating solution, one minute NaOCL+Chitosan and Three minute NaOCL+Chitosan in people with Pulpal Necrosis, run by Suez Canal University at 1 site in Egypt.
Trial summary
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group): Group1(control group): The teeth will be irrigated by 2 ml 1% NaOCl after each file. Read more about this study
- Who is it for?
- Ages 3 to 7 months
- Conditions the study is for
- Pulpal Necrosis
- What is being tested?
- Sodium hypochlorite irrigating solution, one minute NaOCL+Chitosan and Three minute NaOCL+Chitosan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2022to 20 Dec 2023
- 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 3 to 7 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Apparently healthy Children aged from three to seven years.
- No previous history of antibiotics for at least two weeks.
- Non- Vital primary teeth that can be fully isolated.
- Presence of clinical signs or symptoms suggesting a non-vital tooth, such as intra-oral fistula.
- Infection diagnosed by presence of periapical radiolucency in a periapical radiograph.
- Root resorption not more than one third of the root.
- Patient and parent cooperation.
Who cannot join
- Non-restorable tooth
- Serious reduction in bone support and/or extreme tooth mobility.
- Radiographic indication of extensive internal or external root resorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Radiographical and Microbiological Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):
Group1(control group):
Read more
The teeth will be irrigated by 2 ml 1% NaOCl after each file.
Group2:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
Group 3:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes.
Evaluation
Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold.
Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively.
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated.
Bacteriology :
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University.
PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.
Read the detailed description
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):
Group1(control group):
The teeth will be irrigated by 2 ml 1% NaOCl after each file.
Group2:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
Group 3:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes.
The root canals will then be flushed with 5 ml saline. Second microbiological sample will be collected. The tooth will be dried using paper points and then will be temporarily sealed with glass ionomer restoration.
Second Visit (after two days):
Glass ionomer will be removed and the third microbiological sample will be collected.
Zinc oxide and eugenol will be used as root canal filling material. All cases will be subjected to clinical and radiographical evaluation.
Evaluation
Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold.
Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively.
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated.
Bacteriology :
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University.
PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.
Microbiological sample collection protocol:
Two sterile paper points will be introduced into the canals until they reached the full working length, and kept in place for 60 seconds (19). Each paper point will be immediately embedded in 3ml sterile tube containing adequate transporting medium or saline solution.
The first tube will be transported to the microbiological laboratory for culturing within a maximum of 2 hours, while the other tube will be kept at -80 °C for DNA extraction and direct detection of Enterococcus faecalis via multiplex PCR assay.
- Conditions
- Pulpal Necrosis
- Being tested
- Sodium hypochlorite irrigating solution, one minute NaOCL+Chitosan, Three minute NaOCL+Chitosan
- 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.
Sodium hypochlorite irrigating solutionProcedure or surgery
2 ml 1% NaOCl after each file
one minute NaOCL+ChitosanProcedure or surgery
2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
Three minute NaOCL+ChitosanProcedure or surgery
2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The teeth will be irrigated by 2 ml 1% NaOCl after each file. Receives: Procedure: Sodium hypochlorite irrigating solution |
| One-minute NaOCL+Chitosan | Experimental | The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute. Receives: Procedure: one minute NaOCL+Chitosan |
| Three-minute NaOCL+Chisosan | Experimental | The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute. Receives: Procedure: Three minute NaOCL+Chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontanous Pain
Visual analog scale "A scale from 1 to 10 where 1 is mild pain and 10 Worst pain"
Measured: after one month, 3 months, six months and 12 months
Radiographical evaluation
The change of radiolucency
Measured: immediately after restoration, 3 months, six months and 12 months
Radiographic examination " internal or external root resorption"
Presence (1) or absence (0)
Measured: immediately after restoration, 3 months, six months and 12 months
Bacteriology
PCR will be used for detection of Enterococcus faecalis.
- Microbiological investigation will be used for counting the number of Enterococcus faecalis
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start14 Nov 2022
- Primary completion14 Nov 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpal NecrosisStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506526
- Sponsor's protocol ID
- # 33/2017
- Status last verified
- Jul 2024
- First submitted
- 16 Mar 2024
- Last updated
- 17 Jul 2024
- 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 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographical and Microbiological Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
- ClinicalTrials.gov ID
- NCT06506526
- Acronym / sponsor ID
- # 33/2017
- Conditions
- Pulpal Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 17 Jul 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.
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):
Group1(control group):
The teeth will be irrigated by 2 ml 1% NaOCl after each file.
Group2:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
Group 3:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes.
Evaluation
Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold.
Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively.
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated.
Bacteriology :
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University.
PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.
Detailed description
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):
Group1(control group):
The teeth will be irrigated by 2 ml 1% NaOCl after each file.
Group2:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
Group 3:
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes.
The root canals will then be flushed with 5 ml saline. Second microbiological sample will be collected. The tooth will be dried using paper points and then will be temporarily sealed with glass ionomer restoration.
Second Visit (after two days):
Glass ionomer will be removed and the third microbiological sample will be collected.
Zinc oxide and eugenol will be used as root canal filling material. All cases will be subjected to clinical and radiographical evaluation.
Evaluation
Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold.
Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively.
The decrease of radiolucency and the presence of internal or external root resorption will be evaluated.
Bacteriology :
The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University.
PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.
Microbiological sample collection protocol:
Two sterile paper points will be introduced into the canals until they reached the full working length, and kept in place for 60 seconds (19). Each paper point will be immediately embedded in 3ml sterile tube containing adequate transporting medium or saline solution.
The first tube will be transported to the microbiological laboratory for culturing within a maximum of 2 hours, while the other tube will be kept at -80 °C for DNA extraction and direct detection of Enterococcus faecalis via multiplex PCR assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Sodium hypochlorite irrigating solutionThe teeth will be irrigated by 2 ml 1% NaOCl after each file. |
| One-minute NaOCL+Chitosan | Experimental | Procedure: one minute NaOCL+ChitosanThe teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute. |
| Three-minute NaOCL+Chisosan | Experimental | Procedure: Three minute NaOCL+ChitosanThe teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute. |
Who may qualify
- Ages
- 3 to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Apparently healthy Children aged from three to seven years.
- No previous history of antibiotics for at least two weeks.
- Non- Vital primary teeth that can be fully isolated.
- Presence of clinical signs or symptoms suggesting a non-vital tooth, such as intra-oral fistula.
- Infection diagnosed by presence of periapical radiolucency in a periapical radiograph.
Key exclusion criteria (3 listed)
- Non-restorable tooth
- Serious reduction in bone support and/or extreme tooth mobility.
- Radiographic indication of extensive internal or external root resorption.
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 |
|---|---|---|
| Sodium hypochlorite irrigating solution2 ml 1% NaOCl after each file | Procedure or surgery | Control group |
| one minute NaOCL+Chitosan2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute. | Procedure or surgery | One-minute NaOCL+Chitosan |
| Three minute NaOCL+Chitosan2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute. | Procedure or surgery | Three-minute NaOCL+Chisosan |
Primary outcome
Spontanous Pain
Time frame: after one month, 3 months, six months and 12 months
Visual analog scale "A scale from 1 to 10 where 1 is mild pain and 10 Worst pain"
Radiographical evaluation
Time frame: immediately after restoration, 3 months, six months and 12 months
The change of radiolucency
Radiographic examination " internal or external root resorption"
Time frame: immediately after restoration, 3 months, six months and 12 months
Presence (1) or absence (0)
Bacteriology
Time frame: During procedure
PCR will be used for detection of Enterococcus faecalis. - Microbiological investigation will be used for counting the number of Enterococcus faecalis
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 17 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Pulpal Necrosis
Not yet recruiting
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)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
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
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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 study testing Sodium hypochlorite irrigating solution, one minute NaOCL+Chitosan and Three minute NaOCL+Chitosan in people with Pulpal Necrosis, run by Suez Canal 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 3 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 17 Jul 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. 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?
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?
Spontanous Pain (time frame: after one month, 3 months, six months and 12 months). The study lists 4 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 17 Jul 2024.