Apical PeriodontitisNCT05653947
Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis
A study testing Root canal instrumentation, 2.5% NaOCl irrigation in people with Apical Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
This clinical study aimed to Compare the levels of Interleukin 8 before and after root canal treatment in patients with apical periodontitis Diagnosis Local anesthesia Isolation and disinfection of the tooth Two-staged access cavity preparation Patency of the root canals First sample collection using paper points… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Root canal instrumentation, 2.5% NaOCl irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2022to 25 Nov 2022
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients
- Single canaled teeth diagnosed clinically with symptomatic apical periodontitis.
- Radiographic widening in the periodontal membrane space.
- Presence of pain on percussion.
- Patients' acceptance to participate in the trial.
Who cannot join
- Medically compromised patients.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- Teeth that shows association with acute periapical abscess or swelling: Need special treatment steps which could involve additional visits with incision and drainage.
- Presence of periodontal disease
- Non restorability
- Immature teeth
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytokine Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis: Clinical Trial
This clinical study aimed to Compare the levels of Interleukin 8 before and after root canal treatment in patients with apical periodontitis
- Diagnosis
- Local anesthesia
- Isolation and disinfection of the tooth
- Two-staged access cavity preparation
- Patency of the root canals
- First sample collection using paper points
- Working length determination
- Chemico-mechanical preparation
- After 1 week, isolation, Second sample collection then obturation of the root canals and restoration of the tooth.
- Samples will be stored in (-80 C) freezer till collection of all samples then, quantification will be done using ELISA.
Read the detailed description
Diagnosis:
- Personal data including name, address and phone number in addition to medical history and dental history will be collected from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of symptomatic apical periodontitis (SAP) either associated with vital or necrotic teeth.
- Extra-oral and intra-oral clinical examination of the suspected tooth will be performed tentatively using a diagnostic mirror and probe.
- Radiograph will be taken using bisecting angle technique with a periapical digital sensor.
- The diagnosis of symptomatic apical periodontitis is confirmed through positive percussion test.
- After completing the diagnosis, the patient will be enrolled in the study.
Treatment procedure:
- Local anesthesia: Anesthetizing the tooth using infiltration technique by local anesthesia (4% Articiane).
- Isolation and disinfection: Operative field, including the tooth, the clamp, and rubber dam sheet will be disinfected using 30% hydrogen peroxide followed by 5% sodium hypochlorite solution. Subsequently, 5% sodium thiosulfate will be used to inactivate the disinfecting agents.
- Access cavity preparation: a 2-stage access cavity preparation will be performed. The first stage involves the removal of caries and/or coronal restorations using sterile diamond bur. In the second stage, before entering the pulp chamber, the cavity will be disinfected according to the previous decontamination protocol. Then, a new round bur and tapered stone with round end will be used for access cavity preparation.
- Patency of the root canal will be confirmed using stainless steel hand K-files size #10 and #15.
First sample collection: (PS-1) The pre-instrumentation periapical sample will be collected before cleaning and shaping by introducing a fine sterile size 15 paper point 2 mm beyond the canal terminus for 1 minute. This procedure will be performed twice. The paper points will be placed in a sterile micro-centrifugation tube, and immediately transferred to a -80 °C freezer until further testing.
- Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex. Then the canal will be enlarged to size #20.
- Mechanical preparation will be performed using ProTaper Next rotary files in X-smart endodontic motor with adjusted speed (200rpm) and torque (2Ncm) according to the manufacturer's instructions.
The rotary files were introduced inside the canal using ethylenediaminetetraacetic acid (EDTA) gel with the following sequence:
- Orifice opener (size 40, taper 0.08) will be used to negotiate the coronal one-third of the canal is a slow downward movement without application of pressure.
- X1 (size 17, taper 0.04), will be used to negotiate the canal till the full working length is reached
- X2 (size 25, taper 0.06), will be used to full working length is reached
- X3 (size 30, taper 0.07), will be used to full working length is reached 8. The canal will be thoroughly irrigated with 2.5% sodium hypochlorite (NaOCl) root canal irrigant (5ml for 1 min) using disposable plastic syringe with side vented needle gauge 30 reaching 1 mm short of the working length. All teeth will receive the same volume of irrigant (5 ml prior to instrumentation, 5 ml between each file and 5 ml as final flush after root canal instrumentation to reach a total volume of 25 ml in total).
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of saline to inactivate the NaOCl.
- The access cavity will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week.
- After 1 week, rubber dam will be applied Second sample collection: (PS-2) The post-instrumentation periapical sample will be collected following the same protocol mentioned. Then, master cone verification radiograph will be taken to ensure proper length and fit. Obturation will be done by modified single cone technique using epoxy resin sealer (Adseal) and 4% taper gutta percha cones together with auxillary cones.
- The access cavity will be restored with composite resin and occlusal contact will be checked.
- After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before and after root canal instrumentation and irrigation. The kit is used according to the manufacturer's recommendations.
- Conditions
- Apical Periodontitis
- Being tested
- Root canal instrumentation, 2.5% NaOCl irrigation
- Keywords
- interleukin 8, apical periodontitis
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal instrumentation, 2.5% NaOCl irrigationProcedure or surgery
Root canal instrumentation, 2.5% NaOCl irrigation
| Study group | Role | What they receive |
|---|---|---|
| Vital teeth | Experimental | root canal instrumentation sodium hypochlorite 2.5% irrigation Receives: Procedure: Root canal instrumentation, 2.5% NaOCl irrigation |
| Non-vital teeth | Other | root canal instrumentation sodium hypochlorite 2.5% irrigation Receives: Procedure: Root canal instrumentation, 2.5% NaOCl irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 8
Cytokine expression of IL8
Measured: immediately after access cavity preparation and immediately after root canal instrumentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start10 Mar 2022
- Primary completion30 Jul 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Abouelenien, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653947
- Sponsor's protocol ID
- S.Abouelenien
- Status last verified
- Jan 2023
- First submitted
- 27 Nov 2022
- Last updated
- 19 Jan 2023
- Results posted
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Expression of IL-8 Before and After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis: Clinical Trial
- ClinicalTrials.gov ID
- NCT05653947
- Acronym / sponsor ID
- S.Abouelenien
- Conditions
- Apical Periodontitis
- Keywords
- interleukin 8, apical periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 16 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.
This clinical study aimed to Compare the levels of Interleukin 8 before and after root canal treatment in patients with apical periodontitis
- Diagnosis
- Local anesthesia
- Isolation and disinfection of the tooth
- Two-staged access cavity preparation
- Patency of the root canals
- First sample collection using paper points
- Working length determination
- Chemico-mechanical preparation
- After 1 week, isolation, Second sample collection then obturation of the root canals and restoration of the tooth.
- Samples will be stored in (-80 C) freezer till collection of all samples then, quantification will be done using ELISA.
Detailed description
Diagnosis:
- Personal data including name, address and phone number in addition to medical history and dental history will be collected from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of symptomatic apical periodontitis (SAP) either associated with vital or necrotic teeth.
- Extra-oral and intra-oral clinical examination of the suspected tooth will be performed tentatively using a diagnostic mirror and probe.
- Radiograph will be taken using bisecting angle technique with a periapical digital sensor.
- The diagnosis of symptomatic apical periodontitis is confirmed through positive percussion test.
- After completing the diagnosis, the patient will be enrolled in the study.
Treatment procedure:
- Local anesthesia: Anesthetizing the tooth using infiltration technique by local anesthesia (4% Articiane).
- Isolation and disinfection: Operative field, including the tooth, the clamp, and rubber dam sheet will be disinfected using 30% hydrogen peroxide followed by 5% sodium hypochlorite solution. Subsequently, 5% sodium thiosulfate will be used to inactivate the disinfecting agents.
- Access cavity preparation: a 2-stage access cavity preparation will be performed. The first stage involves the removal of caries and/or coronal restorations using sterile diamond bur. In the second stage, before entering the pulp chamber, the cavity will be disinfected according to the previous decontamination protocol. Then, a new round bur and tapered stone with round end will be used for access cavity preparation.
- Patency of the root canal will be confirmed using stainless steel hand K-files size #10 and #15.
First sample collection: (PS-1) The pre-instrumentation periapical sample will be collected before cleaning and shaping by introducing a fine sterile size 15 paper point 2 mm beyond the canal terminus for 1 minute. This procedure will be performed twice. The paper points will be placed in a sterile micro-centrifugation tube, and immediately transferred to a -80 °C freezer until further testing.
- Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex. Then the canal will be enlarged to size #20.
- Mechanical preparation will be performed using ProTaper Next rotary files in X-smart endodontic motor with adjusted speed (200rpm) and torque (2Ncm) according to the manufacturer's instructions.
The rotary files were introduced inside the canal using ethylenediaminetetraacetic acid (EDTA) gel with the following sequence:
- Orifice opener (size 40, taper 0.08) will be used to negotiate the coronal one-third of the canal is a slow downward movement without application of pressure.
- X1 (size 17, taper 0.04), will be used to negotiate the canal till the full working length is reached
- X2 (size 25, taper 0.06), will be used to full working length is reached
- X3 (size 30, taper 0.07), will be used to full working length is reached 8. The canal will be thoroughly irrigated with 2.5% sodium hypochlorite (NaOCl) root canal irrigant (5ml for 1 min) using disposable plastic syringe with side vented needle gauge 30 reaching 1 mm short of the working length. All teeth will receive the same volume of irrigant (5 ml prior to instrumentation, 5 ml between each file and 5 ml as final flush after root canal instrumentation to reach a total volume of 25 ml in total).
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of saline to inactivate the NaOCl.
- The access cavity will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week.
- After 1 week, rubber dam will be applied Second sample collection: (PS-2) The post-instrumentation periapical sample will be collected following the same protocol mentioned. Then, master cone verification radiograph will be taken to ensure proper length and fit. Obturation will be done by modified single cone technique using epoxy resin sealer (Adseal) and 4% taper gutta percha cones together with auxillary cones.
- The access cavity will be restored with composite resin and occlusal contact will be checked.
- After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before and after root canal instrumentation and irrigation. The kit is used according to the manufacturer's recommendations.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vital teeth | Experimental | Procedure: Root canal instrumentation, 2.5% NaOCl irrigationroot canal instrumentation sodium hypochlorite 2.5% irrigation |
| Non-vital teeth | Other | Procedure: Root canal instrumentation, 2.5% NaOCl irrigationroot canal instrumentation sodium hypochlorite 2.5% irrigation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medically free patients
- Single canaled teeth diagnosed clinically with symptomatic apical periodontitis.
- Radiographic widening in the periodontal membrane space.
- Presence of pain on percussion.
- Patients' acceptance to participate in the trial.
Key exclusion criteria (8 listed)
- Medically compromised patients.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- Teeth that shows association with acute periapical abscess or swelling: Need special treatment steps which could involve additional visits with incision and drainage.
- Presence of periodontal disease
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 |
|---|---|---|
| Root canal instrumentation, 2.5% NaOCl irrigationRoot canal instrumentation, 2.5% NaOCl irrigation | Procedure or surgery | Non-vital teeth, Vital teeth |
Primary outcome
interleukin 8
Time frame: immediately after access cavity preparation and immediately after root canal instrumentation
Cytokine expression of IL8
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 19 Jan 2023.
- Individual participant dataSharing planned: No
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Necrotic Pulps With no 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.
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 Root canal instrumentation, 2.5% NaOCl irrigation in people with Apical Periodontitis, run by Cairo 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 8 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 19 Jan 2023. 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?
interleukin 8 (time frame: immediately after access cavity preparation and immediately after root canal instrumentation). 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 19 Jan 2023.