Post Operative PainNCT05841290
The Incidence of Postoperative Pain After Using Different Types of Sealers
A study testing Primary local anesthesia, Supplemental local anesthesia and Removal Of Caries and Access Cavity in people with Post Operative Pain and Root Canal Sealers, run by British University In Egypt at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial is to evaluate and compare the incidence and intensity of post-operative pain after obturation using resin and silicon-based sealers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Root Canal Sealers, Sillicon Based Sealers
- What is being tested?
- Primary local anesthesia, Supplemental local anesthesia and Removal Of Caries and Access Cavity
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to Oct 2024
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patient's age ranges from 18-50 years old.
- Patients with teeth diagnosed with symptomatic irreversible pulpitis.
- Normal periapical condition confirmed by normal periapical radiograph
- The teeth are restorable
- Teeth are periodontally free, with no mobility and negative to percussion and palpation test.
Who cannot join
- • Teeth with immature roots
- Non restorable teeth
- Medically compromised patients with systemic complication that would alter the treatment.
- Necrotic teeth
- Teeth with apical periodontitis or periapical lesions
- necrotic Teeth.
Trial locations and contacts
1 site in 1 country.
Kareem Mohammed Elhoseny, ORCID:0009-0001-6101-5615, Bachelor contact
Egypt1 site, 1 recruiting
- Recruiting
British University in Egypt
El Shorouk, Cairo Governorate, +20 19283
About this study
Official title: The Incidence of Postoperative Pain After Using Different Types of Sealers (A Randomized Clinical Trial)
The aim of this randomized clinical trial is to evaluate and compare the incidence and intensity of post-operative pain after obturation using resin and silicon-based sealers.
Read the detailed description
The main objectives of root canal therapy are to achieve long-term comfort, function, and aesthetics for the patients and prevention of reinfection of tooth. These objectives are provided through complete cleaning, shaping, and obturation of canals of affected teeth .
Some patients may report moderate-to-severe pain and/or swelling following root canal treatment .
This is detrimental for both patient and dentist and may entail an unscheduled emergency visit by patients to relieve their symptoms.
Postoperative pain is considered a clinical outcome that exhibits the multifactorial nature of patients' responses to variables among treatment procedures such as maintaining the working length to the apical constriction, finishing the endodontic treatment in single visit or multiple visit, instrumentation technique and the type of endodontic sealer used for obturation .
Such pain occurrence is mainly due to mechanical, chemical or microbial injury to the periapical tissues .
Trauma of periapical tissue or bacterial extrusion and root canal sealer specifically, extrusion of root canal sealer can disrupt periodontal tissues and cause inflammatory reactions. The intensity of this reaction depends on the composition of the sealer .
Root canal sealers can play a crucial role in this regard by coming in contact with the periapical tissues through apical foramen and lateral canals causing a localized inflammation with a direct influence on the degree of inflammation based on the composition of the sealer in turn influencing postoperative pain levels .
Silicone is inert and biocompatible and has been widely used in medicine as an implant material Silicone-based root-canal sealers are also available. However, there are no data on the clinical performance of this type of material in endodontic treatment .
- Being tested
- Primary local anesthesia, Supplemental local anesthesia, Removal Of Caries and Access Cavity, Rubber dam isolation of tooth, Bleeding control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary local anesthesiaProcedure or surgery
Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
Supplemental local anesthesiaProcedure or surgery
Also called intraligamentary injection / Intrapulpal Anesthesia
if needed
Removal Of Caries and Access CavityProcedure or surgery
- Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing.
Rubber dam isolation of toothProcedure or surgery
Rubber dam isolation of tooth using certain clamps .
Bleeding controlProcedure or surgery
bleeding is controlled by using excavator for the removing the pulp tissue . using a piece of cotton soaked with Sodium hypochlorite. using local anesthesia with vasoconstrictor if needed and if suitable for the patient.
Canal negotiationProcedure or surgery
Also called Coronal patency, Apical patency
Coronal patency of the coronal and the Middle part of the canal using file #10 Apical patency of the apical part of the canal using #10
Coronal flaringProcedure or surgery
Coronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls
Working Length Determination (W.L)Procedure or surgery
Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph.
Glide pathProcedure or surgery
Glide path of the canal Using #10 ,15 ,20 ,25 K files till becoming Super-Loose Inside the Canal at the recorded w.l to create a path for the rotary file .
IrrigationProcedure or surgery
Irrigation using 5.25% sodium hypochlorite introduced using side vented needle
Cleaning and shaping using rotary systemProcedure or surgery
Cleaning and shaping using rotary system plus irrigation and apical patency between every rotary file .
Second w.l determinationProcedure or surgery
Second w.l determination using electronic apex locator before using final finishing rotary file .
Apical gaugingProcedure or surgery
Establish the depth of apical constriction - this is the zero reading on your apex locator. your working length will be 0.5mm - 1mm short of this.
After cleaning and preparing the canal system to your working length, passively insert 02 taper hand files, starting from #15. If the file goes past the apical constriction (your working length + 0.5-1mm), then choose the next largest file and repeat.
When a file passively binds short of the apical constriction, that will be the upper limit of the apical constriction diameter. The smaller file before that would be the lower limit.
Apical gauging helps with:
Choosing the best master cone that closely matches canal length and taper Achieving true tug back - as opposed to false tug back! Minimising gutta percha extrusions during obturation
Activation of the irrigantProcedure or surgery
Activation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation
Master cone checkProcedure or surgery
Master cone check Clinically and confirmatory radiograph
application of resin based sealer inside the canal in the resin based sealer groupDrug
Also called AH plus
application done by inserting inside the canal by spreader or master cone
application of the sillicon based sealer inside the canal in the sillicon based groupDiagnostic test
Also called Gutta flow 2
application done by injection inside the canal
ObturationProcedure or surgery
done by lateral condensation technique
Visual Analogue Scale (VAS)Diagnostic test
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
| Study group | Role | What they receive |
|---|---|---|
| Group (1) Resin Based Sealer intervention | Experimental | evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers. Receives: Procedure: Primary local anesthesia; Procedure: Supplemental local anesthesia; Procedure: Removal Of Caries and Access Cavity; Procedure: Rubber dam isolation of tooth; Procedure: Bleeding control; Procedure: Canal negotiation; Procedure: Coronal flaring; Procedure: Working Length Determination (W.L); Procedure: Glide path; Procedure: Irrigation; Procedure: Cleaning and shaping using rotary system; Procedure: Second w.l determination; Procedure: Apical gauging; Procedure: Activation of the irrigant; Procedure: Master cone check; Drug: application of resin based sealer inside the canal in the resin based sealer group; Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group; Procedure: Obturation; Diagnostic Test: Visual Analogue Scale (VAS) |
| Group (2) Silicone Based Sealer intervention | Experimental | evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers. Receives: Procedure: Primary local anesthesia; Procedure: Supplemental local anesthesia; Procedure: Removal Of Caries and Access Cavity; Procedure: Rubber dam isolation of tooth; Procedure: Bleeding control; Procedure: Canal negotiation; Procedure: Coronal flaring; Procedure: Working Length Determination (W.L); Procedure: Glide path; Procedure: Irrigation; Procedure: Cleaning and shaping using rotary system; Procedure: Second w.l determination; Procedure: Apical gauging; Procedure: Activation of the irrigant; Procedure: Master cone check; Drug: application of resin based sealer inside the canal in the resin based sealer group; Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group; Procedure: Obturation; Diagnostic Test: Visual Analogue Scale (VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain" Each Outcome Measure should typically only specify a single time point of assessment
Measured: after 6 hours of endodontic treatment
Postoperative pain
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Measured: after 12 hours of endodontic treatment
Postoperative pain
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Measured: after 24 hours of endodontic treatment
Postoperative pain
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Measured: after 48 hours of endodontic treatment
Postoperative pain
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Measured: after 72 hours of endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Aug 2022
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Model description
- Root Canal Treatment (RCT) with 2 parallel groups, two arms, superiority trial with 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem darwish, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841290
- Sponsor's protocol ID
- 22-017
- Status last verified
- Jul 2024
- First submitted
- 16 Dec 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Torabinejad M, White SN. Endodontic treatment options after unsuccessful initial root canal treatment: Alternatives to single-tooth implants. J Am Dent Assoc. 2016 Mar;147(3):214-20. doi: 10.1016/j.adaj.2015.11.017. Epub 2016 Jan 9.
PubMed 26778004Javidi M, Zarei M, Ashrafpour E, Gharechahi M, Bagheri H. Post-treatment Flare-up Incidence after Using Nano Zinc Oxide Eugenol Sealer in Mandibular First Molars with Irreversible Pulpitis. J Dent (Shiraz). 2020 Dec;21(4):307-313. doi: 10.30476/DENTJODS.2020.83231.1041.
PubMed 33344681AlRahabi MK. Predictors, prevention, and management of postoperative pain associated with nonsurgical root canal treatment: A systematic review. J Taibah Univ Med Sci. 2017 May 9;12(5):376-384. doi: 10.1016/j.jtumed.2017.03.004. eCollection 2017 Oct.
PubMed 31435267Genet JM, Hart AA, Wesselink PR, Thoden van Velzen SK. Preoperative and operative factors associated with pain after the first endodontic visit. Int Endod J. 1987 Mar;20(2):53-64. doi: 10.1111/j.1365-2591.1987.tb00590.x. No abstract available.
PubMed 3471726Christian Gomes Moura C, Cristina Cunha T, Oliveira Crema V, Dechichi P, Carlos Gabrielli Biffi J. A study on biocompatibility of three endodontic sealers: intensity and duration of tissue irritation. Iran Endod J. 2014 Spring;9(2):137-43. Epub 2014 Mar 8.
PubMed 24688584Zhang W, Peng B. Tissue reactions after subcutaneous and intraosseous implantation of iRoot SP, MTA and AH Plus. Dent Mater J. 2015;34(6):774-80. doi: 10.4012/dmj.2014-271.
PubMed 26632225Habal MB. The biologic basis for the clinical application of the silicones. A correlate to their biocompatibility. Arch Surg. 1984 Jul;119(7):843-8. doi: 10.1001/archsurg.1984.01390190081019.
PubMed 6375634Marcus DA. Interrelationships of neurochemicals, estrogen, and recurring headache. Pain. 1995 Aug;62(2):129-139. doi: 10.1016/0304-3959(95)00052-T.
PubMed 8545137Dao TT, Knight K, Ton-That V. Modulation of myofascial pain by the reproductive hormones: a preliminary report. J Prosthet Dent. 1998 Jun;79(6):663-70. doi: 10.1016/s0022-3913(98)70073-3.
PubMed 9627895Walton R, Fouad A. Endodontic interappointment flare-ups: a prospective study of incidence and related factors. J Endod. 1992 Apr;18(4):172-7. doi: 10.1016/S0099-2399(06)81413-5.
PubMed 1402571Mehrvarzfar P, Shababi B, Sayyad R, Fallahdoost A, Kheradpir K. Effect of supraperiosteal injection of dexamethasone on postoperative pain. Aust Endod J. 2008 Apr;34(1):25-9. doi: 10.1111/j.1747-4477.2007.00076.x.
PubMed 18352900Ali SG, Mulay S, Palekar A, Sejpal D, Joshi A, Gufran H. Prevalence of and factors affecting post-obturation pain following single visit root canal treatment in Indian population: A prospective, randomized clinical trial. Contemp Clin Dent. 2012 Oct;3(4):459-63. doi: 10.4103/0976-237X.107440.
PubMed 23633809Watkins CA, Logan HL, Kirchner HL. Anticipated and experienced pain associated with endodontic therapy. J Am Dent Assoc. 2002 Jan;133(1):45-54. doi: 10.14219/jada.archive.2002.0020.
PubMed 11811742Cleghorn BM, Christie WH, Dong CC. Root and root canal morphology of the human permanent maxillary first molar: a literature review. J Endod. 2006 Sep;32(9):813-21. doi: 10.1016/j.joen.2006.04.014. Epub 2006 Jun 30.
PubMed 16934622Claffey E, Reader A, Nusstein J, Beck M, Weaver J. Anesthetic efficacy of articaine for inferior alveolar nerve blocks in patients with irreversible pulpitis. J Endod. 2004 Aug;30(8):568-71. doi: 10.1097/01.don.0000125317.21892.8f.
PubMed 15273637
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Postoperative Pain After Using Different Types of Sealers (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05841290
- Acronym / sponsor ID
- 22-017
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 3 May 2023 (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 randomized clinical trial is to evaluate and compare the incidence and intensity of post-operative pain after obturation using resin and silicon-based sealers.
Detailed description
The main objectives of root canal therapy are to achieve long-term comfort, function, and aesthetics for the patients and prevention of reinfection of tooth. These objectives are provided through complete cleaning, shaping, and obturation of canals of affected teeth .
Some patients may report moderate-to-severe pain and/or swelling following root canal treatment .
This is detrimental for both patient and dentist and may entail an unscheduled emergency visit by patients to relieve their symptoms.
Postoperative pain is considered a clinical outcome that exhibits the multifactorial nature of patients' responses to variables among treatment procedures such as maintaining the working length to the apical constriction, finishing the endodontic treatment in single visit or multiple visit, instrumentation technique and the type of endodontic sealer used for obturation .
Such pain occurrence is mainly due to mechanical, chemical or microbial injury to the periapical tissues .
Trauma of periapical tissue or bacterial extrusion and root canal sealer specifically, extrusion of root canal sealer can disrupt periodontal tissues and cause inflammatory reactions. The intensity of this reaction depends on the composition of the sealer .
Root canal sealers can play a crucial role in this regard by coming in contact with the periapical tissues through apical foramen and lateral canals causing a localized inflammation with a direct influence on the degree of inflammation based on the composition of the sealer in turn influencing postoperative pain levels .
Silicone is inert and biocompatible and has been widely used in medicine as an implant material Silicone-based root-canal sealers are also available. However, there are no data on the clinical performance of this type of material in endodontic treatment .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Root Canal Treatment (RCT) with 2 parallel groups, two arms, superiority trial with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Group (1) Resin Based Sealer intervention | Experimental | Procedure: Primary local anesthesia, Procedure: Supplemental local anesthesia, Procedure: Removal Of Caries and Access Cavity, Procedure: Rubber dam isolation of tooth, Procedure: Bleeding control, Procedure: Canal negotiation, Procedure: Coronal flaring, Procedure: Working Length Determination (W.L), Procedure: Glide path, Procedure: Irrigation, Procedure: Cleaning and shaping using rotary system, Procedure: Second w.l determination, Procedure: Apical gauging, Procedure: Activation of the irrigant, Procedure: Master cone check, Drug: application of resin based sealer inside the canal in the resin based sealer group, Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group, Procedure: Obturation, Diagnostic Test: Visual Analogue Scale (VAS)evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers. |
| Group (2) Silicone Based Sealer intervention | Experimental | Procedure: Primary local anesthesia, Procedure: Supplemental local anesthesia, Procedure: Removal Of Caries and Access Cavity, Procedure: Rubber dam isolation of tooth, Procedure: Bleeding control, Procedure: Canal negotiation, Procedure: Coronal flaring, Procedure: Working Length Determination (W.L), Procedure: Glide path, Procedure: Irrigation, Procedure: Cleaning and shaping using rotary system, Procedure: Second w.l determination, Procedure: Apical gauging, Procedure: Activation of the irrigant, Procedure: Master cone check, Drug: application of resin based sealer inside the canal in the resin based sealer group, Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group, Procedure: Obturation, Diagnostic Test: Visual Analogue Scale (VAS)evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patient's age ranges from 18-50 years old.
Key exclusion criteria (6 listed)
- • Teeth with immature roots
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 |
|---|---|---|
| Primary local anesthesiaTooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000. | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Supplemental local anesthesiaAlso: intraligamentary injection / Intrapulpal Anesthesiaif needed | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Removal Of Caries and Access Cavity• Access cavity will be performed using a carbide round steel bur and tapered diamond stone until complete deroofing. | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Rubber dam isolation of toothRubber dam isolation of tooth using certain clamps . | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Bleeding controlbleeding is controlled by using excavator for the removing the pulp tissue . using a piece of cotton soaked with Sodium hypochlorite. using local anesthesia with vasoconstrictor if needed and if suitable for the patient. | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Canal negotiationAlso: Coronal patency, Apical patencyCoronal patency of the coronal and the Middle part of the canal using file #10 Apical patency of the apical part of the canal using #10 | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Coronal flaringCoronal flaring using Orifice opener of a certain Rotary system in and out motion first then brushing motion touching all the canal walls | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Working Length Determination (W.L)Working length determination (W.L) using #10 K File , working length is recorded using apex locator and confirmatory radiograph. | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Glide pathGlide path of the canal Using #10 ,15 ,20 ,25 K files till becoming Super-Loose Inside the Canal at the recorded w.l to create a path for the rotary file . | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| IrrigationIrrigation using 5.25% sodium hypochlorite introduced using side vented needle | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Cleaning and shaping using rotary systemCleaning and shaping using rotary system plus irrigation and apical patency between every rotary file . | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Second w.l determinationSecond w.l determination using electronic apex locator before using final finishing rotary file . | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Apical gaugingEstablish the depth of apical constriction - this is the zero reading on your apex locator. your working length will be 0.5mm - 1mm short of this. After cleaning and preparing the canal system to your working length, passively insert 02 taper hand files, starting from #15. If the file goes past the apical constriction (your working length + 0.5-1mm), then choose the next largest file and repeat. When a file passively binds short of the apical constriction, that will be the upper limit of the apical constriction diameter. The smaller file before that would be the lower limit. Apical gauging helps with: Choosing the best master cone that closely matches canal length and taper Achieving true tug back - as opposed to false tug back! Minimising gutta percha extrusions during obturation | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Activation of the irrigantActivation of the irrigant using Manual Dynamic Agitation and Ultra x or eddy tips for activation | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Master cone checkMaster cone check Clinically and confirmatory radiograph | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| application of resin based sealer inside the canal in the resin based sealer groupAlso: AH plusapplication done by inserting inside the canal by spreader or master cone | Drug | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| application of the sillicon based sealer inside the canal in the sillicon based groupAlso: Gutta flow 2application done by injection inside the canal | Diagnostic test | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Obturationdone by lateral condensation technique | Procedure or surgery | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
| Visual Analogue Scale (VAS)Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain" | Diagnostic test | Group (1) Resin Based Sealer intervention, Group (2) Silicone Based Sealer intervention |
Primary outcome
Postoperative pain
Time frame: after 6 hours of endodontic treatment
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain" Each Outcome Measure should typically only specify a single time point of assessment
Postoperative pain
Time frame: after 12 hours of endodontic treatment
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Postoperative pain
Time frame: after 24 hours of endodontic treatment
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Postoperative pain
Time frame: after 48 hours of endodontic treatment
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Postoperative pain
Time frame: after 72 hours of endodontic treatment
Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 26778004Torabinejad M, White SN. Endodontic treatment options after unsuccessful initial root canal treatment: Alternatives to single-tooth implants. J Am Dent Assoc. 2016 Mar;147(3):214-20. doi: 10.1016/j.adaj.2015.11.017. Epub 2016 Jan 9.
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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.
Kareem Mohammed Elhoseny, ORCID:0009-0001-6101-5615, Bachelor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary local anesthesia, Supplemental local anesthesia and Removal Of Caries and Access Cavity in people with Post Operative Pain and Root Canal Sealers, run by British University In Egypt 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 6 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 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kareem Mohammed Elhoseny, ORCID:0009-0001-6101-5615, Bachelor (01157215056, Kareem.Darwish@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: after 6 hours of endodontic treatment). The study lists 5 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 NCT05841290, which also lists 28 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 8 Jul 2024.