RetreatmentPhase 2CSNIMSRRTNCT04213716

Comparison of the Efficacy of Calcium Hydroxide With Silver Nanoparticle and Conventional Calcium Hydroxide Intra Canal Medications on Post-Operative Pain in Symptomatic Root Canal Treatment Failure Cases:

A Phase 2 study testing silver nano particulate solution mixed with calcium hydroxide powder and conventional calcium hydroxide in people with Retreatment and Root Canal Retreatment, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study is to measure and compare the effectiveness of nanosilver combined calcium hydroxide and conventional calcium hydroxide intracanal medications in reducing postoperative pain in patients with Symptomatic Root Canal treatment Failure . Read more about this study

Who is it for?: Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Retreatment, Root Canal Retreatment, Nonsurgical Retreatment
What is being tested?: silver nano particulate solution mixed with calcium hydroxide powder and conventional calcium hydroxide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteEgypt
Study dates: 15 Jun 2015to 12 Dec 2016
Phase: Phase 2
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 25 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Medically free patients.
Patient's age between 25-50 years.
Anterior or premolar teeth diagnosed clinically and radio graphically as symptomatic root canal treatment failure.
Positive patient's acceptance for participation in the study.
Sex include both male and female.
Patients who can understand Numerical Rating Scale (NRS)
Patients able to sign informed consent.

Who cannot join

Pregnancy or lactation.
Medically compromised patients.
Patient with multiple teeth that required retreatment to eliminate the possibility of pain referral.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Endodontic Department , Faculty of Dentistry , Cairo University
Cairo

Other trials in Egypt

About this study

Official title: Comparison of the Efficacy of Calcium Hydroxide Combined With Silver Nano Particulate and Conventional Calcium Hydroxide Intra Canal Medications on Post-Operative Pain in Symptomatic Root Canal Treatment Failure Cases: A Randomized Clinical Trial Therapeutic Study

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:

First session:

Patients will be asked to rate their pain level on NRS before treatment is started.
Patient will be anesthetized by using nerve block local anesthesia or infiltration local anesthesia according to the tooth location in mandibular or maxillary arch respectively.
Previous coronal restoration will be removed:
If the access will be cut through metal (amalgam alloy or cast metal) or composite resin, carbide fissure bur will be used.
In case of porcelain fused to metal (PFM) crown a round diamond is used to cut through the porcelain layer, then Transmetal bur is used to cut through and remove the core material.
Teeth will be isolated with rubber dam.
Gutta percha removal will be done using protaper rotary retreatment files in the following manner D1 has a cutting tip to facilitate initial penetration into the filling material (coronal third). D2 and D3 both have non-cutting tips and are used to remove material from the middle and apical thirds, respectively using gutta percha solvent
Working length will be determined using an electronic apex locator then confirmed with intraoral periapical radiograph, to be 0.5-1 mm, shorter than radiographic apex.
Cleaning and shaping will be done using crown down preparation technique with the use of protaper rotary files in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instruments.
MD-Chelcream will be used as lubricant during mechanical preparation.
After instrumentation of the canals paper points (Protaper Paper Points) will be used for drying.
Using Lentulo Spiral Filler, medicaments will be placed under aseptic conditions into the canals according to each group, Experimental group Ca (OH) 2 ( Ca (OH) 2with nanosilver suspension and comparison group Ca (OH) 2 with sterile water then access cavity will be closed with a temporary filling
Patient will be instructed to call in case of severe pain in between visits, an emergency analgesics are to be prescribed to the patient (Brufen 400mg)

Second session:

After 7 days, rubber dam will be placed , the temporary fillings will be removed and master apical file will be introduced in each root canal to loosen medicament and to create a space for subsequent irrigant, then each root canal will be washed with 5 mL of sterile saline, irrigated with 1 mL of 20% citric acid and again irrigated with 5 mL sterile saline.
Dryness of the canals by paper points (Protaper Paper Points).
Obturation will be carried out using the cold lateral condensation technique with protaper gutta percha cones and resin sealer with spreader size according to master cone size , its depth short 2 mm of the working length, and auxiliary cones size 25.
After obturation a cotton pellet will be placed in the pulp chamber and the access cavity will be closed with a temporary filling to avoid coronal leakage.
The patient is given a NRS and asked to rate his pain level at 6, 12, 24 \& 48 hours after root canal retreatment .

Conditions: Retreatment, Root Canal Retreatment, Nonsurgical Retreatment, Endodontic Failure, Symptomatic Endodontic Failure, Nanosilver
Being tested: silver nano particulate solution mixed with calcium hydroxide powder, conventional calcium hydroxide
Keywords: Keywords provided by rawda mohammad abdel rahman baghdady, Cairo University:, root canal retreatment, calcium hydroxide, distilled water, silver nanoparticles, postoperative pain
Medical subject headings: Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

silver nano particulate solution mixed with calcium hydroxide powderCombination product
1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication
conventional calcium hydroxideCombination product
1ml of distilled water mixed with 100 mg of calcium hydroxide powder and used as intracanal medication after root canal retreatment

Study groups in NCT04213716
Study group	Role	What they receive
intracanal medication	Experimental	After instrumentation of the canals and drying , using Lentulo Spiral Filler medicaments will be placed under aseptic conditions into the canals experimental Intracanal medication of 1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication Receives: Combination Product: silver nano particulate solution mixed with calcium hydroxide powder
intracanal medicament	Active comparator	After instrumentation of the canals and drying , using Lentulo Spiral Filler comparator intracanal medicaments will be placed under aseptic conditions into the canals which is 100 mg Ca (OH) 2 mixed with 1ml sterile water Receives: Combination Product: conventional calcium hydroxide

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the second visit (after obturation)
Measured: [ Time Frame:6 hours ]
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the second visit (after obturation)
Measured: [ Time Frame: 12 hours ]
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the second visit (after obturation)
Measured: [ Time Frame: 24 hours ]
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the second visit (after obturation)
Measured: [ Time Frame: 48 hours ]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201512 Dec 2016

First posted30 Dec 2019
Study start15 Jun 2015
Primary completionJun 2016
Study completion12 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for RetreatmentStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Interventions: (60) Intracanal medication of 1ml combined nanosilver particle solution 30ppm / 100 mg calcium hydroxide Control : (60) Intracanal medication of 100 mg powder of calcium hydroxide mixed with 1ml distilled water
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04213716
Sponsor's protocol ID: ENDO-CU-2014-9-14
Acronym: CSNIMSRRT
Status last verified: Dec 2019
First submitted: 21 Dec 2019
Last updated: 2 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Siqueira JF Jr. Aetiology of root canal treatment failure: why well-treated teeth can fail. Int Endod J. 2001 Jan;34(1):1-10. doi: 10.1046/j.1365-2591.2001.00396.x.
PubMed 11307374
Daokar DS, Kalekar DA "Endodontic Failures-A Review," Journal of Dental and Medical Sciences 4(5): 5-10, 2013
Siqueira JF Jr, Rocas IN, Favieri A, Machado AG, Gahyva SM, Oliveira JC, Abad EC. Incidence of postoperative pain after intracanal procedures based on an antimicrobial strategy. J Endod. 2002 Jun;28(6):457-60. doi: 10.1097/00004770-200206000-00010.
PubMed 12067129
Peciuliene V, Reynaud AH, Balciuniene I, Haapasalo M. Isolation of yeasts and enteric bacteria in root-filled teeth with chronic apical periodontitis. Int Endod J. 2001 Sep;34(6):429-34. doi: 10.1046/j.1365-2591.2001.00411.x.
PubMed 11556508
Gama TG, de Oliveira JC, Abad EC, Rocas IN, Siqueira JF Jr. Postoperative pain following the use of two different intracanal medications. Clin Oral Investig. 2008 Dec;12(4):325-30. doi: 10.1007/s00784-008-0199-3. Epub 2008 Apr 10.
PubMed 18401602
Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
PubMed 23657409
Kawashima N, Wadachi R, Suda H, Yeng T, Parashos P. Root canal medicaments. Int Dent J. 2009 Feb;59(1):5-11.
PubMed 19323305
Wu D, Fan W, Kishen A, Gutmann JL, Fan B. Evaluation of the antibacterial efficacy of silver nanoparticles against Enterococcus faecalis biofilm. J Endod. 2014 Feb;40(2):285-90. doi: 10.1016/j.joen.2013.08.022. Epub 2013 Oct 1.
PubMed 24461420
M. Mustafa, D. Jain, M. Kadri and etal. , " Role of Calcium Hydroxide in Endodontics : A Review," Global Journal of Medical and Public Health,vol. 1, no. 1, pp. 53-57, 2012.
Silveira CF, Cunha RS, Fontana CE, de Martin AS, Gomes BP, Motta RH, da Silveira Bueno CE. Assessment of the antibacterial activity of calcium hydroxide combined with chlorhexidine paste and other intracanal medications against bacterial pathogens. Eur J Dent. 2011 Jan;5(1):1-7.
PubMed 21311611
Pacios MG, Silva C, Lopez ME, Cecilia M. Antibacterial action of calcium hydroxide vehicles and calcium hydroxide pastes. J Investig Clin Dent. 2012 Nov;3(4):264-70. doi: 10.1111/j.2041-1626.2012.00147.x.
PubMed 23129141
Vianna ME, Gomes BP, Sena NT, Zaia AA, Ferraz CC, de Souza Filho FJ. In vitro evaluation of the susceptibility of endodontic pathogens to calcium hydroxide combined with different vehicles. Braz Dent J. 2005;16(3):175-80. doi: 10.1590/s0103-64402005000300001. Epub 2006 Jan 12.
PubMed 16429180
Yoldas O, Topuz A, Isci AS, Oztunc H. Postoperative pain after endodontic retreatment: single- versus two-visit treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Oct;98(4):483-7. doi: 10.1016/j.tripleo.2004.03.009.
PubMed 15472665
Adl A, Hamedi S, Sedigh Shams M, Motamedifar M, Sobhnamayan F. The ability of triple antibiotic paste and calcium hydroxide in disinfection of dentinal tubules. Iran Endod J. 2014 Spring;9(2):123-6. Epub 2014 Mar 8.
PubMed 24688581
Cwikla SJ, Belanger M, Giguere S, Progulske-Fox A, Vertucci FJ. Dentinal tubule disinfection using three calcium hydroxide formulations. J Endod. 2005 Jan;31(1):50-2. doi: 10.1097/01.don.0000134291.03828.d1.
PubMed 15614007

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Retreatment trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Efficacy of Calcium Hydroxide Combined With Silver Nano Particulate and Conventional Calcium Hydroxide Intra Canal Medications on Post-Operative Pain in Symptomatic Root Canal Treatment Failure Cases: A Randomized Clinical Trial Therapeutic Study
ClinicalTrials.gov ID: NCT04213716
Acronym / sponsor ID: CSNIMSRRT / ENDO-CU-2014-9-14
Conditions: Retreatment, Root Canal Retreatment, Nonsurgical Retreatment, Endodontic Failure, Symptomatic Endodontic Failure, Nanosilver
Keywords: Keywords provided by rawda mohammad abdel rahman baghdady, Cairo University:, root canal retreatment, calcium hydroxide, distilled water, silver nanoparticles, postoperative pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 15 Jun 2015 (actual)
Primary completion: Jun 2016 (actual)
Study completion: 12 Dec 2016 (actual)
First posted: 30 Dec 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.

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:

First session:

Patients will be asked to rate their pain level on NRS before treatment is started.
Patient will be anesthetized by using nerve block local anesthesia or infiltration local anesthesia according to the tooth location in mandibular or maxillary arch respectively.
Previous coronal restoration will be removed:
If the access will be cut through metal (amalgam alloy or cast metal) or composite resin, carbide fissure bur will be used.
In case of porcelain fused to metal (PFM) crown a round diamond is used to cut through the porcelain layer, then Transmetal bur is used to cut through and remove the core material.
Teeth will be isolated with rubber dam.
Gutta percha removal will be done using protaper rotary retreatment files in the following manner D1 has a cutting tip to facilitate initial penetration into the filling material (coronal third). D2 and D3 both have non-cutting tips and are used to remove material from the middle and apical thirds, respectively using gutta percha solvent
Working length will be determined using an electronic apex locator then confirmed with intraoral periapical radiograph, to be 0.5-1 mm, shorter than radiographic apex.
Cleaning and shaping will be done using crown down preparation technique with the use of protaper rotary files in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instruments.
MD-Chelcream will be used as lubricant during mechanical preparation.
After instrumentation of the canals paper points (Protaper Paper Points) will be used for drying.
Using Lentulo Spiral Filler, medicaments will be placed under aseptic conditions into the canals according to each group, Experimental group Ca (OH) 2 ( Ca (OH) 2with nanosilver suspension and comparison group Ca (OH) 2 with sterile water then access cavity will be closed with a temporary filling
Patient will be instructed to call in case of severe pain in between visits, an emergency analgesics are to be prescribed to the patient (Brufen 400mg)

Second session:

After 7 days, rubber dam will be placed , the temporary fillings will be removed and master apical file will be introduced in each root canal to loosen medicament and to create a space for subsequent irrigant, then each root canal will be washed with 5 mL of sterile saline, irrigated with 1 mL of 20% citric acid and again irrigated with 5 mL sterile saline.
Dryness of the canals by paper points (Protaper Paper Points).
Obturation will be carried out using the cold lateral condensation technique with protaper gutta percha cones and resin sealer with spreader size according to master cone size , its depth short 2 mm of the working length, and auxiliary cones size 25.
After obturation a cotton pellet will be placed in the pulp chamber and the access cavity will be closed with a temporary filling to avoid coronal leakage.
The patient is given a NRS and asked to rate his pain level at 6, 12, 24 \& 48 hours after root canal retreatment .

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Interventions: (60) Intracanal medication of 1ml combined nanosilver particle solution 30ppm / 100 mg calcium hydroxide Control : (60) Intracanal medication of 100 mg powder of calcium hydroxide mixed with 1ml distilled water

Arm	Type	Receives
intracanal medication	Experimental	Combination Product: silver nano particulate solution mixed with calcium hydroxide powderAfter instrumentation of the canals and drying , using Lentulo Spiral Filler medicaments will be placed under aseptic conditions into the canals experimental Intracanal medication of 1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication
intracanal medicament	Active comparator	Combination Product: conventional calcium hydroxideAfter instrumentation of the canals and drying , using Lentulo Spiral Filler comparator intracanal medicaments will be placed under aseptic conditions into the canals which is 100 mg Ca (OH) 2 mixed with 1ml sterile water

Who may qualify

Ages: 25 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Medically free patients.
Patient's age between 25-50 years.
Anterior or premolar teeth diagnosed clinically and radio graphically as symptomatic root canal treatment failure.
Positive patient's acceptance for participation in the study.
Sex include both male and female.

Key exclusion criteria (3 listed)

Pregnancy or lactation.
Medically compromised patients.
Patient with multiple teeth that required retreatment to eliminate the possibility of pain referral.

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
silver nano particulate solution mixed with calcium hydroxide powder1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication	Combination product	intracanal medication
conventional calcium hydroxide1ml of distilled water mixed with 100 mg of calcium hydroxide powder and used as intracanal medication after root canal retreatment	Combination product	intracanal medicament

Primary outcome

Postoperative pain using a pain-measuring scale
Time frame: [ Time Frame:6 hours ]
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the second visit (after obturation)
Postoperative pain using a pain-measuring scale
Time frame: [ Time Frame: 12 hours ]
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the second visit (after obturation)
Postoperative pain using a pain-measuring scale
Time frame: [ Time Frame: 24 hours ]
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the second visit (after obturation)
Postoperative pain using a pain-measuring scale
Time frame: [ Time Frame: 48 hours ]
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the second visit (after obturation)

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 2 Jan 2020.
Background: PubMed 11307374Siqueira JF Jr. Aetiology of root canal treatment failure: why well-treated teeth can fail. Int Endod J. 2001 Jan;34(1):1-10. doi: 10.1046/j.1365-2591.2001.00396.x.
BackgroundDaokar DS, Kalekar DA "Endodontic Failures-A Review," Journal of Dental and Medical Sciences 4(5): 5-10, 2013
Background: PubMed 12067129Siqueira JF Jr, Rocas IN, Favieri A, Machado AG, Gahyva SM, Oliveira JC, Abad EC. Incidence of postoperative pain after intracanal procedures based on an antimicrobial strategy. J Endod. 2002 Jun;28(6):457-60. doi: 10.1097/00004770-200206000-00010.
Background: PubMed 11556508Peciuliene V, Reynaud AH, Balciuniene I, Haapasalo M. Isolation of yeasts and enteric bacteria in root-filled teeth with chronic apical periodontitis. Int Endod J. 2001 Sep;34(6):429-34. doi: 10.1046/j.1365-2591.2001.00411.x.
Background: PubMed 18401602Gama TG, de Oliveira JC, Abad EC, Rocas IN, Siqueira JF Jr. Postoperative pain following the use of two different intracanal medications. Clin Oral Investig. 2008 Dec;12(4):325-30. doi: 10.1007/s00784-008-0199-3. Epub 2008 Apr 10.
Background: PubMed 23657409Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
Background: PubMed 19323305Kawashima N, Wadachi R, Suda H, Yeng T, Parashos P. Root canal medicaments. Int Dent J. 2009 Feb;59(1):5-11.
Background: PubMed 24461420Wu D, Fan W, Kishen A, Gutmann JL, Fan B. Evaluation of the antibacterial efficacy of silver nanoparticles against Enterococcus faecalis biofilm. J Endod. 2014 Feb;40(2):285-90. doi: 10.1016/j.joen.2013.08.022. Epub 2013 Oct 1.
BackgroundM. Mustafa, D. Jain, M. Kadri and etal. , " Role of Calcium Hydroxide in Endodontics : A Review," Global Journal of Medical and Public Health,vol. 1, no. 1, pp. 53-57, 2012.
Background: PubMed 21311611Silveira CF, Cunha RS, Fontana CE, de Martin AS, Gomes BP, Motta RH, da Silveira Bueno CE. Assessment of the antibacterial activity of calcium hydroxide combined with chlorhexidine paste and other intracanal medications against bacterial pathogens. Eur J Dent. 2011 Jan;5(1):1-7.
Background: PubMed 23129141Pacios MG, Silva C, Lopez ME, Cecilia M. Antibacterial action of calcium hydroxide vehicles and calcium hydroxide pastes. J Investig Clin Dent. 2012 Nov;3(4):264-70. doi: 10.1111/j.2041-1626.2012.00147.x.
Background: PubMed 16429180Vianna ME, Gomes BP, Sena NT, Zaia AA, Ferraz CC, de Souza Filho FJ. In vitro evaluation of the susceptibility of endodontic pathogens to calcium hydroxide combined with different vehicles. Braz Dent J. 2005;16(3):175-80. doi: 10.1590/s0103-64402005000300001. Epub 2006 Jan 12.
Individual participant dataSharing planned: No

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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.

Rawda baghdady, M.S.c principal investigator

Cairo University

Jealan El shafei, professor study director

Cairo University

Alaa El baz, assist prof 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?

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 2 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Postoperative pain using a pain-measuring scale (time frame: [ Time Frame:6 hours ]). 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?

On the ClinicalTrials.gov record for NCT04213716, which also lists 26 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 2 Jan 2020.