Necrotic PulpPhase 4NCT04035070
Effect of Irrigation With Antibiotic-containing Solutions on Postoperative Pain and Intra-canal Bacteria
A Phase 4 study testing co-amoxiclav-clindamycin solution, MTAD and 2.5% sodium hypochlorite in people with Necrotic Pulp, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the degree of postoperative pain and the antimicrobial effect in terms of bacterial count reduction after using co-amoxiclav-clindamycin solution versus MTAD and sodium hypochlorite irrigating solutions in patients with necrotic pulp. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- co-amoxiclav-clindamycin solution, MTAD and 2.5% sodium hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2021to Jun 2021
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maxillary/mandibular single-rooted permanent teeth:
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pain.
- Normal/slight widening in the periodontal membrane space (PMS).
- Patients' acceptance to participate in the trial.
- Patients who can understand numerical rating scale (NRS) and can sign the informed consent.
Who cannot join
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients show higher incidence of pain and lower healing rate.
- Patients with known allergy to penicillin or penicillin derivatives.
- Pregnant females: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively: Might alter their pain perception.
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
- Teeth that show association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
Show all 10Show fewer
- Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
- Non-restorable teeth.
- Immature teeth.
- Radiographic evidence of periapical radiolucency, external or internal root resorption, vertical root fracture, perforation or calcification.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Endodontic Department - Faculty of Dentistry - Cairo University
Cairo
About this study
Official title: Effect of Irrigation With Antibiotic-containing Solutions Versus Sodium Hypochlorite on Postoperative Pain and Intra-canal Bacteria in Teeth With Necrotic Pulps (a Randomized Double-blind Clinical Trial)
- The aim of this study is to compare the degree of postoperative pain and the antimicrobial effect in terms of bacterial count reduction after using co-amoxiclav-clindamycin solution versus MTAD and sodium hypochlorite irrigating solutions in patients with necrotic pulp.
Read the detailed description
- After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study.
- The operator will complete treatment of all cases in two visits as follows:
- Anesthesia will be achieved using inferior alveolar nerve block for mandibular premolar teeth and infiltration technique for maxillary anterior teeth with local anesthesic solution of 1.8 mL of 2% Mepivacaine HCl with 1:100,000 epinephrine.
- Caries and/or coronal restorations will be completely removed with sterile bur and rubber dam will then be applied.
- The operative field, including the tooth, the clamp and rubber dam sheet will be cleaned with 30% hydrogen peroxide for 30 seconds, followed by a sterile cotton swab with 5.25% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.
- Access cavity will be prepared using a sterile round carbide bur size 3 and a sterile Endo-Z bur.
- The operative field and the pulp chamber will be cleaned and disinfected once again in the same way mentioned above.
- Patency of the root canals will be achieved using #10 or #15 size stainless steel hand K-files. Working length (WL) will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex.
- Debridement and mechanical preparation will be performed with the initial file along with 2 mL of 0.9% sterile saline solution and then a pre-instrumentation sample will be collected from the root canal.
- The pre-instrumentation sample (S1) will be collected as follows: a sterile paper point will be placed inside the root canal to soak up the fluid in the canal to a level approximately 1 mm short of the tooth apex. The paper point will be left in the canal for 60 seconds. This will be repeated using three sterile paper points. Paper points will then be transferred aseptically to tubes containing 20 mL of sterile thioglycolate broth. Microbiological analysis To test for the presence of cultivable bacteria, cultures will be inoculated in thioglycolate broth. For the identification of main anaerobic taxa, the root canal samples will be plated on 5% sheep blood agar, neomycin blood agar and phenyl ethyl alcohol agar with metronidazole (5μg, Oxoid, Basingstoke, UK) disc. Cultures will be incubated at 37°C for 72 hours in an anaerobic chamber . In addition, specimens will also be cultured aerobically on 5% sheep blood agar and MacConkey's agar.
- Mechanical preparation will be completed in a crown down technique with Protaper Next rotary files set on an endodontic motor adjusted at a speed of 300 rpm and torque of 2 Ncm. In-and-out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle, and apical thirds until attaining the established WL. All root canals will be enlarged to size X4 (40.06). The canal will be irrigated and recapitulated after the use of each instrument according to the allocated group as follows: Group 1: Alternate irrigation with 1 mL antibiotic-containing solution followed by 4 mL 2.5% sodium hypochlorite solution between each size instrument and the consequent one. The antibiotic-containing solution will be prepared by mixing equal quantities of 1.2 gm Co-amoxiclav solution and 600 mg Clindamycin solution at a ratio of 1:1 by volume. Group 2: Irrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one. Group 3 (control): Irrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one.
- The root canal will be thoroughly irrigated with the allocated irrigant using a plastic disposable syringe with a gauge 30 side-vented needle reaching 1 mm short of the WL. The canal will then be dried using sterile paper points.
- Canals irrigated with NaOCl (groups 1 and 3) will be flushed with 5 mL of 5% sodium thiosulfate to inactivate the NaOCl followed by 5 mL 0.9% sterile saline solution. Canals irrigated with MTAD (group 2) will be flushed with 5 mL 0.9% sterile saline solution.
- A post-instrumentation sample (S2) will be taken as previously described and then the cavity will be sealed with a sterile cotton pellet and a temporary filling material .
- The patient will be instructed to record their pain level on NRS at 24 and 48 hours postoperatively and will be recalled after 72 hours. The patient will be prescribed Ibuprofen (400 mg) to be taken in case of intolerable pain.
- In the recall appointment, the root canal will be accessed under sterile conditions and will be flushed with 1mL sterile saline solution before a third sample (S3) is taken as previously described.
- Master cone fit radiograph will be taken and then the root canal will be dried using sterile paper points and filled with gutta percha points and resin-based sealer using cold lateral condensation technique.
- Access cavity will be sealed with a temporary filling material and the final restoration will be placed within one week.
- The patient will be asked to report any swelling, in such case, he/she will be appointed for clinical examination to assess the severity by a blinded assessor and to determine if systemic antibiotics/drainage will be needed.
- Conditions
- Necrotic Pulp
- Being tested
- co-amoxiclav-clindamycin solution, MTAD, 2.5% sodium hypochlorite
- Keywords
- antibiotic-containg solution, co-amoxiclav-clindamycin solution, MTAD, sodium hypochlorite, postoperative pain, antimicrobial efficacy, root canal irrigation
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-amoxiclav-clindamycin solutionCombination product
antibiotic-containing solution will be prepared by mixing equal quantities of 1.2gm Co-amoxiclav solution and 600mg Clindamycin solution at a ratio of 1:1 by volume to be used as a root canal irrigating solution
MTADCombination product
Also called BioPure MTAD
mixture of 3% doxycycline hyclate, 4.25% citric acid and detergent (Tween 80) to be used as a root canal irrigating solution
2.5% sodium hypochloriteCombination product
It will be prepared by adding 10mL of sterile distilled water to 10mL of 5.25% sodium hypochlorite solution to be used as a root canal irrigating solution
| Study group | Role | What they receive |
|---|---|---|
| Root canal irrigation with co-amoxiclav-clindamycin solution | Experimental | Alternate irrigation with 1 mL antibiotic-containing solution followed by 4 mL 2.5% sodium hypochlorite solution between each size instrument and the consequent one. The antibiotic-containing solution will be prepared by mixing equal quantities of 1.2 gm Co-amoxiclav solution and 600 mg Clindamycin solution at a ratio of 1:1 by volume. Receives: Combination Product: co-amoxiclav-clindamycin solution |
| Root canal irrigation with MTAD | Experimental | Irrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one. Receives: Combination Product: MTAD |
| Root canal irrigation with 2.5% sodium hypochlorite | Active comparator | Irrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one. Receives: Combination Product: 2.5% sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain: numerical rating scale
intensity of pain by numerical rating scale from 0 to 10
Measured: up to 48 hours after the first visit
Secondary outcomes (1)
intra-canal bacterial count
pre and post-instrumentation samples to count intra-canal bacteria (CFU/mL)
Measured: 72 hours after root canal preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study startJan 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Karam Eissa Elias, Cairo University
- Investigators
- Michel K Elias, M.Sc., Principal investigator, Cairo UniversityMaged M Negm, Ph.D., Study director, Cairo UniversityHeba El-Asfouri, Ph.D., Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035070
- Sponsor's protocol ID
- CEBC-CU-2019-10-145
- Status last verified
- Oct 2020
- First submitted
- 21 Jul 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
PubMed 21419285El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003.
PubMed 20003932Kovac J, Kovac D. Effect of irrigating solutions in endodontic therapy. Bratisl Lek Listy. 2011;112(7):410-5.
PubMed 21744739Saleh IM, Ruyter IE, Haapasalo M, Orstavik D. Survival of Enterococcus faecalis in infected dentinal tubules after root canal filling with different root canal sealers in vitro. Int Endod J. 2004 Mar;37(3):193-8. doi: 10.1111/j.0143-2885.2004.00785.x.
PubMed 15009409Estrela C, Estrela CR, Barbin EL, Spano JC, Marchesan MA, Pecora JD. Mechanism of action of sodium hypochlorite. Braz Dent J. 2002;13(2):113-7. doi: 10.1590/s0103-64402002000200007.
PubMed 12238801Siqueira JF Jr, Machado AG, Silveira RM, Lopes HP, de Uzeda M. Evaluation of the effectiveness of sodium hypochlorite used with three irrigation methods in the elimination of Enterococcus faecalis from the root canal, in vitro. Int Endod J. 1997 Jul;30(4):279-82. doi: 10.1046/j.1365-2591.1997.00096.x.
PubMed 9477814Siqueira JF Jr, Rocas IN, Favieri A, Lima KC. Chemomechanical reduction of the bacterial population in the root canal after instrumentation and irrigation with 1%, 2.5%, and 5.25% sodium hypochlorite. J Endod. 2000 Jun;26(6):331-4. doi: 10.1097/00004770-200006000-00006.
PubMed 11199749McComb D, Smith DC. A preliminary scanning electron microscopic study of root canals after endodontic procedures. J Endod. 1975 Jul;1(7):238-42. doi: 10.1016/S0099-2399(75)80226-3. No abstract available.
PubMed 1061799Grigoratos D, Knowles J, Ng YL, Gulabivala K. Effect of exposing dentine to sodium hypochlorite and calcium hydroxide on its flexural strength and elastic modulus. Int Endod J. 2001 Mar;34(2):113-9. doi: 10.1046/j.1365-2591.2001.00356.x.
PubMed 11307259Sim TP, Knowles JC, Ng YL, Shelton J, Gulabivala K. Effect of sodium hypochlorite on mechanical properties of dentine and tooth surface strain. Int Endod J. 2001 Mar;34(2):120-32. doi: 10.1046/j.1365-2591.2001.00357.x.
PubMed 11307260Mohammadi Z, Abbott PV. Antimicrobial substantivity of root canal irrigants and medicaments: a review. Aust Endod J. 2009 Dec;35(3):131-9. doi: 10.1111/j.1747-4477.2009.00164.x.
PubMed 19961451Torabinejad M, Cho Y, Khademi AA, Bakland LK, Shabahang S. The effect of various concentrations of sodium hypochlorite on the ability of MTAD to remove the smear layer. J Endod. 2003 Apr;29(4):233-9. doi: 10.1097/00004770-200304000-00001.
PubMed 12701769Shabahang S, Torabinejad M. Effect of MTAD on Enterococcus faecalis-contaminated root canals of extracted human teeth. J Endod. 2003 Sep;29(9):576-9. doi: 10.1097/00004770-200309000-00008.
PubMed 14503830Zhang W, Torabinejad M, Li Y. Evaluation of cytotoxicity of MTAD using the MTT-tetrazolium method. J Endod. 2003 Oct;29(10):654-7. doi: 10.1097/00004770-200310000-00010.
PubMed 14606789Machnick TK, Torabinejad M, Munoz CA, Shabahang S. Effect of MTAD on flexural strength and modulus of elasticity of dentin. J Endod. 2003 Nov;29(11):747-50. doi: 10.1097/00004770-200311000-00015.
PubMed 14651283
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Irrigation With Antibiotic-containing Solutions Versus Sodium Hypochlorite on Postoperative Pain and Intra-canal Bacteria in Teeth With Necrotic Pulps (a Randomized Double-blind Clinical Trial)
- ClinicalTrials.gov ID
- NCT04035070
- Acronym / sponsor ID
- CEBC-CU-2019-10-145
- Conditions
- Necrotic Pulp
- Keywords
- antibiotic-containg solution, co-amoxiclav-clindamycin solution, MTAD, sodium hypochlorite, postoperative pain, antimicrobial efficacy, root canal irrigation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 Jul 2019 (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.
- The aim of this study is to compare the degree of postoperative pain and the antimicrobial effect in terms of bacterial count reduction after using co-amoxiclav-clindamycin solution versus MTAD and sodium hypochlorite irrigating solutions in patients with necrotic pulp.
Detailed description
- After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study.
- The operator will complete treatment of all cases in two visits as follows:
- Anesthesia will be achieved using inferior alveolar nerve block for mandibular premolar teeth and infiltration technique for maxillary anterior teeth with local anesthesic solution of 1.8 mL of 2% Mepivacaine HCl with 1:100,000 epinephrine.
- Caries and/or coronal restorations will be completely removed with sterile bur and rubber dam will then be applied.
- The operative field, including the tooth, the clamp and rubber dam sheet will be cleaned with 30% hydrogen peroxide for 30 seconds, followed by a sterile cotton swab with 5.25% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.
- Access cavity will be prepared using a sterile round carbide bur size 3 and a sterile Endo-Z bur.
- The operative field and the pulp chamber will be cleaned and disinfected once again in the same way mentioned above.
- Patency of the root canals will be achieved using #10 or #15 size stainless steel hand K-files. Working length (WL) will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex.
- Debridement and mechanical preparation will be performed with the initial file along with 2 mL of 0.9% sterile saline solution and then a pre-instrumentation sample will be collected from the root canal.
- The pre-instrumentation sample (S1) will be collected as follows: a sterile paper point will be placed inside the root canal to soak up the fluid in the canal to a level approximately 1 mm short of the tooth apex. The paper point will be left in the canal for 60 seconds. This will be repeated using three sterile paper points. Paper points will then be transferred aseptically to tubes containing 20 mL of sterile thioglycolate broth. Microbiological analysis To test for the presence of cultivable bacteria, cultures will be inoculated in thioglycolate broth. For the identification of main anaerobic taxa, the root canal samples will be plated on 5% sheep blood agar, neomycin blood agar and phenyl ethyl alcohol agar with metronidazole (5μg, Oxoid, Basingstoke, UK) disc. Cultures will be incubated at 37°C for 72 hours in an anaerobic chamber . In addition, specimens will also be cultured aerobically on 5% sheep blood agar and MacConkey's agar.
- Mechanical preparation will be completed in a crown down technique with Protaper Next rotary files set on an endodontic motor adjusted at a speed of 300 rpm and torque of 2 Ncm. In-and-out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle, and apical thirds until attaining the established WL. All root canals will be enlarged to size X4 (40.06). The canal will be irrigated and recapitulated after the use of each instrument according to the allocated group as follows: Group 1: Alternate irrigation with 1 mL antibiotic-containing solution followed by 4 mL 2.5% sodium hypochlorite solution between each size instrument and the consequent one. The antibiotic-containing solution will be prepared by mixing equal quantities of 1.2 gm Co-amoxiclav solution and 600 mg Clindamycin solution at a ratio of 1:1 by volume. Group 2: Irrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one. Group 3 (control): Irrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one.
- The root canal will be thoroughly irrigated with the allocated irrigant using a plastic disposable syringe with a gauge 30 side-vented needle reaching 1 mm short of the WL. The canal will then be dried using sterile paper points.
- Canals irrigated with NaOCl (groups 1 and 3) will be flushed with 5 mL of 5% sodium thiosulfate to inactivate the NaOCl followed by 5 mL 0.9% sterile saline solution. Canals irrigated with MTAD (group 2) will be flushed with 5 mL 0.9% sterile saline solution.
- A post-instrumentation sample (S2) will be taken as previously described and then the cavity will be sealed with a sterile cotton pellet and a temporary filling material .
- The patient will be instructed to record their pain level on NRS at 24 and 48 hours postoperatively and will be recalled after 72 hours. The patient will be prescribed Ibuprofen (400 mg) to be taken in case of intolerable pain.
- In the recall appointment, the root canal will be accessed under sterile conditions and will be flushed with 1mL sterile saline solution before a third sample (S3) is taken as previously described.
- Master cone fit radiograph will be taken and then the root canal will be dried using sterile paper points and filled with gutta percha points and resin-based sealer using cold lateral condensation technique.
- Access cavity will be sealed with a temporary filling material and the final restoration will be placed within one week.
- The patient will be asked to report any swelling, in such case, he/she will be appointed for clinical examination to assess the severity by a blinded assessor and to determine if systemic antibiotics/drainage will be needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Root canal irrigation with co-amoxiclav-clindamycin solution | Experimental | Combination Product: co-amoxiclav-clindamycin solutionAlternate irrigation with 1 mL antibiotic-containing solution followed by 4 mL 2.5% sodium hypochlorite solution between each size instrument and the consequent one. The antibiotic-containing solution will be prepared by mixing equal quantities of 1.2 gm Co-amoxiclav solution and 600 mg Clindamycin solution at a ratio of 1:1 by volume. |
| Root canal irrigation with MTAD | Experimental | Combination Product: MTADIrrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one. |
| Root canal irrigation with 2.5% sodium hypochlorite | Active comparator | Combination Product: 2.5% sodium hypochloriteIrrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Maxillary/mandibular single-rooted permanent teeth:
- Patients' acceptance to participate in the trial.
- Patients who can understand numerical rating scale (NRS) and can sign the informed consent.
Key exclusion criteria (10 listed)
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients show higher incidence of pain and lower healing rate.
- Patients with known allergy to penicillin or penicillin derivatives.
- Pregnant females: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively: Might alter their pain perception.
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
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 |
|---|---|---|
| co-amoxiclav-clindamycin solutionantibiotic-containing solution will be prepared by mixing equal quantities of 1.2gm Co-amoxiclav solution and 600mg Clindamycin solution at a ratio of 1:1 by volume to be used as a root canal irrigating solution | Combination product | Root canal irrigation with co-amoxiclav-clindamycin solution |
| MTADAlso: BioPure MTADmixture of 3% doxycycline hyclate, 4.25% citric acid and detergent (Tween 80) to be used as a root canal irrigating solution | Combination product | Root canal irrigation with MTAD |
| 2.5% sodium hypochloriteIt will be prepared by adding 10mL of sterile distilled water to 10mL of 5.25% sodium hypochlorite solution to be used as a root canal irrigating solution | Combination product | Root canal irrigation with 2.5% sodium hypochlorite |
Primary outcome
postoperative pain: numerical rating scale
Time frame: up to 48 hours after the first visit
intensity of pain by numerical rating scale from 0 to 10
1 secondary outcome
intra-canal bacterial count
Time frame: 72 hours after root canal preparation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 21419285Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
- Background: PubMed 20003932El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003.
- Background: PubMed 21744739Kovac J, Kovac D. Effect of irrigating solutions in endodontic therapy. Bratisl Lek Listy. 2011;112(7):410-5.
- Background: PubMed 15009409Saleh IM, Ruyter IE, Haapasalo M, Orstavik D. Survival of Enterococcus faecalis in infected dentinal tubules after root canal filling with different root canal sealers in vitro. Int Endod J. 2004 Mar;37(3):193-8. doi: 10.1111/j.0143-2885.2004.00785.x.
- Background: PubMed 12238801Estrela C, Estrela CR, Barbin EL, Spano JC, Marchesan MA, Pecora JD. Mechanism of action of sodium hypochlorite. Braz Dent J. 2002;13(2):113-7. doi: 10.1590/s0103-64402002000200007.
- Background: PubMed 9477814Siqueira JF Jr, Machado AG, Silveira RM, Lopes HP, de Uzeda M. Evaluation of the effectiveness of sodium hypochlorite used with three irrigation methods in the elimination of Enterococcus faecalis from the root canal, in vitro. Int Endod J. 1997 Jul;30(4):279-82. doi: 10.1046/j.1365-2591.1997.00096.x.
- Background: PubMed 11199749Siqueira JF Jr, Rocas IN, Favieri A, Lima KC. Chemomechanical reduction of the bacterial population in the root canal after instrumentation and irrigation with 1%, 2.5%, and 5.25% sodium hypochlorite. J Endod. 2000 Jun;26(6):331-4. doi: 10.1097/00004770-200006000-00006.
- Background: PubMed 1061799McComb D, Smith DC. A preliminary scanning electron microscopic study of root canals after endodontic procedures. J Endod. 1975 Jul;1(7):238-42. doi: 10.1016/S0099-2399(75)80226-3. No abstract available.
- Background: PubMed 11307259Grigoratos D, Knowles J, Ng YL, Gulabivala K. Effect of exposing dentine to sodium hypochlorite and calcium hydroxide on its flexural strength and elastic modulus. Int Endod J. 2001 Mar;34(2):113-9. doi: 10.1046/j.1365-2591.2001.00356.x.
- Background: PubMed 11307260Sim TP, Knowles JC, Ng YL, Shelton J, Gulabivala K. Effect of sodium hypochlorite on mechanical properties of dentine and tooth surface strain. Int Endod J. 2001 Mar;34(2):120-32. doi: 10.1046/j.1365-2591.2001.00357.x.
- Background: PubMed 19961451Mohammadi Z, Abbott PV. Antimicrobial substantivity of root canal irrigants and medicaments: a review. Aust Endod J. 2009 Dec;35(3):131-9. doi: 10.1111/j.1747-4477.2009.00164.x.
- Background: PubMed 12701769Torabinejad M, Cho Y, Khademi AA, Bakland LK, Shabahang S. The effect of various concentrations of sodium hypochlorite on the ability of MTAD to remove the smear layer. J Endod. 2003 Apr;29(4):233-9. doi: 10.1097/00004770-200304000-00001.
- Individual participant dataSharing planned: No
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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.
Michel K Elias, M.Sc. principal investigator
Cairo University
Maged M Negm, Ph.D. study director
Cairo University
Heba El-Asfouri, Ph.D. study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing co-amoxiclav-clindamycin solution, MTAD and 2.5% sodium hypochlorite in people with Necrotic Pulp, 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 6 inclusion and 10 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 14 Oct 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Michel K Elias, M.Sc. (+2 0122 553 5090, michel.karam.5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain: numerical rating scale (time frame: up to 48 hours after the first visit). 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 NCT04035070, which also lists 27 linked publications.
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 14 Oct 2020.