Effects of the ElementsNCT04327453
Effect of Removal of Double Antibiotic Paste on Post Operative Pain
A study testing double antibiotic paste with XP-endo Finisher file, double antibiotic paste with Irrisafe Ultrasonic tip and double antibiotic paste with side vented needle in people with Effects of the Elements, run by Minia University at 1 site in Egypt.
Trial summary
Recruited patients with necrotic pulp after application of double antibiotic paste are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of the Elements
- What is being tested?
- double antibiotic paste with XP-endo Finisher file, double antibiotic paste with Irrisafe Ultrasonic tip and double antibiotic paste with side vented needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2020to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients.
- Patient's age between 20-50 years.
- Both sexes.
- Necrotic pulp as indicated by thermal or electric pulp testing.
- No history of previous endodontic treatment of the tooth.
- Enough crown structure for adequate isolation.
Who cannot join
- Pregnancy or lactation
- Medically compromised patients
- Previous endodontic therapy of the affected tooth.
- Teeth diagnosed with vital pulp.
- Teeth with periodontal pocket more than 3mm deep.
- Teeth with abnormal anatomy or calcified canals.
- Teeth with caries below the bony level (non-restorable tooth).
- Immature teeth with open apices.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and dental medicine, Minia University
Minya
Shaimaa Nasr El-deen, PHD, +0201020271788, dr_shimes@hotmail.com
Shaimaa El-Gaffar, PHD
About this study
Official title: Influence of Different Methods of Removal of Double Antibiotic Paste as an Intracanal Medication on Post Operative Pain:a Randomized Clinical Trial
Recruited patients with necrotic pulp after application of double antibiotic paste are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.
Read the detailed description
The investigator will recruit patients who are found eligible to the criteria, double antibiotic paste will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.
After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet
- Conditions
- Effects of the Elements
- Being tested
- double antibiotic paste with XP-endo Finisher file, double antibiotic paste with Irrisafe Ultrasonic tip, double antibiotic paste with side vented needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double antibiotic paste with XP-endo Finisher fileDevice
XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of double antibiotic paste
double antibiotic paste with Irrisafe Ultrasonic tipDevice
Also called passive ultrasonic irrigation
passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in removal of double antibiotic paste
double antibiotic paste with side vented needleDevice
Also called conventional syringe irrigation
conventional syringe irrigation with side vented needle (prime Dent, India) in removal of double antibiotic paste
| Study group | Role | What they receive |
|---|---|---|
| XP-endo Finisher file | Experimental | removal of double antibiotic paste intracanal medication with XP-endo Finisher file Receives: Device: double antibiotic paste with XP-endo Finisher file |
| Irrisafe Ultrasonic tip | Experimental | removal of double antibiotic paste intracanal medication with passive ultrasonic irrigation Receives: Device: double antibiotic paste with Irrisafe Ultrasonic tip |
| side vented needle | Active comparator | removal of double antibiotic paste intracanal medication with conventional syringe irrigation Receives: Device: double antibiotic paste with side vented needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in post operative pain (Visual Analogue Scale)
Numerical (0-10)
Measured: Intrappointment at 4,24,48,72 and 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Effects of the ElementsStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Nasr El-deen Abd El-gaffar, Minia University
- Investigators
- Magdy Mohamed Ali, Professor, Study chair, Dean of faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327453
- Sponsor's protocol ID
- 3
- Status last verified
- Apr 2020
- First submitted
- 27 Mar 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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 23657409Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
PubMed 20647083Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.
PubMed 25598754
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Methods of Removal of Double Antibiotic Paste as an Intracanal Medication on Post Operative Pain:a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04327453
- Acronym / sponsor ID
- 3
- Conditions
- Effects of the Elements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 31 Mar 2020 (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.
Recruited patients with necrotic pulp after application of double antibiotic paste are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.
Detailed description
The investigator will recruit patients who are found eligible to the criteria, double antibiotic paste will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.
After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XP-endo Finisher file | Experimental | Device: double antibiotic paste with XP-endo Finisher fileremoval of double antibiotic paste intracanal medication with XP-endo Finisher file |
| Irrisafe Ultrasonic tip | Experimental | Device: double antibiotic paste with Irrisafe Ultrasonic tipremoval of double antibiotic paste intracanal medication with passive ultrasonic irrigation |
| side vented needle | Active comparator | Device: double antibiotic paste with side vented needleremoval of double antibiotic paste intracanal medication with conventional syringe irrigation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Medically free patients.
- Patient's age between 20-50 years.
- Both sexes.
- Necrotic pulp as indicated by thermal or electric pulp testing.
- No history of previous endodontic treatment of the tooth.
Key exclusion criteria (8 listed)
- Pregnancy or lactation
- Medically compromised patients
- Previous endodontic therapy of the affected tooth.
- Teeth diagnosed with vital pulp.
- Teeth with periodontal pocket more than 3mm deep.
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 |
|---|---|---|
| double antibiotic paste with XP-endo Finisher fileXP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of double antibiotic paste | Device | XP-endo Finisher file |
| double antibiotic paste with Irrisafe Ultrasonic tipAlso: passive ultrasonic irrigationpassive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in removal of double antibiotic paste | Device | Irrisafe Ultrasonic tip |
| double antibiotic paste with side vented needleAlso: conventional syringe irrigationconventional syringe irrigation with side vented needle (prime Dent, India) in removal of double antibiotic paste | Device | side vented needle |
Primary outcome
change in post operative pain (Visual Analogue Scale)
Time frame: Intrappointment at 4,24,48,72 and 96 hours
Numerical (0-10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- 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.
- Results publication: PubMed 20647083Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
- Results publication: PubMed 25598754Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.
- Individual participant dataSharing planned: Yes
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.
Magdy Mohamed Ali, Professor study chair
Dean of faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double antibiotic paste with XP-endo Finisher file, double antibiotic paste with Irrisafe Ultrasonic tip and double antibiotic paste with side vented needle in people with Effects of the Elements, run by Minia 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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 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.
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 Shaimaa Nasr El-din Abd El-Ghaffar, MsC (+0201020271788, dr_shimes@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in post operative pain (Visual Analogue Scale) (time frame: Intrappointment at 4,24,48,72 and 96 hours). 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 NCT04327453, which also lists 3 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 7 Apr 2020.