Effects of the ElementsNCT04338633
Post-operative Pain Reduction
A study testing Conventional calcium hydroxide paste, Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle 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 conventional calcium hydroxide paste are assigned to group, Calcium hydroxide nanoparticle group and Combined Calcium hydroxide with silver nanoparticle group and record postoperative pain afterwards. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of the Elements
- What is being tested?
- Conventional calcium hydroxide paste, Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle
- 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 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.
- Sex includes both male and female.
- Radiographic evidence of a periapical radiolucent lesion associated with tooth.
- Necrotic pulp as indicated by thermal pulp testing.
- No history of previous endodontic treatment of the tooth.
Who cannot join
- • Teeth with unfavorable conditions for rubber-dam application.
- Teeth with acute periapical abscesses swelling.
- Medically compromised patients.
- Immature teeth with open apices.
- Multi rooted teeth.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Minia University
Minya
Reham Hassan, Assoc Prof, +201001542529, reham-hassan@live.com
About this study
Official title: Post-operative Pain Reduction After Application of Three Intracanal Medicament Within Necrotic Root Canals and Pulp
Recruited patients with necrotic pulp after application of conventional calcium hydroxide paste are assigned to group, Calcium hydroxide nanoparticle group and Combined Calcium hydroxide with silver nanoparticle group and record postoperative pain afterwards.
Read the detailed description
The investigator will recruit patients who are found eligible to the criteria, conventional calcium hydroxide paste , Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle . After 48 hours, patients will be randomly assigned to removal of intracanal medication
After the visit, patients will be asked to record post operative pain by Numerical Rating Scale)in a given sheet
- Conditions
- Effects of the Elements
- Being tested
- Conventional calcium hydroxide paste, Calcium hydroxide nanoparticle, Combined Calcium hydroxide with silver nanoparticle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional calcium hydroxide pasteDrug
Also called Ultracal
Conventional calcium hydroxide paste (Ultracal) will be removed in second visit.
Calcium hydroxide nanoparticleDrug
Calcium hydroxide nanoparticle. manufactured in NanoTech. institute, will be removed in second visit.
Combined Calcium hydroxide with silver nanoparticleDrug
Combined Calcium hydroxide with silver nanoparticle will be removed in second visit.
| Study group | Role | What they receive |
|---|---|---|
| Conventional calcium hydroxide paste | Active comparator | Application of Conventional calcium hydroxide paste Receives: Drug: Conventional calcium hydroxide paste |
| Calcium hydroxide nanoparticle | Experimental | Application of Calcium hydroxide nanoparticle Receives: Drug: Calcium hydroxide nanoparticle |
| Combined Calcium hydroxide with silver nanoparticle | Experimental | Application of Combined Calcium hydroxide with silver nanoparticle Receives: Drug: Combined Calcium hydroxide with silver nanoparticle |
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 posted8 Apr 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 (1)Papers the sponsor has linked to this study.
- Other trials for Effects of the ElementsStudies 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
- 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, Mohamed Salah Mohamed Fahmy, Minia University
- Investigators
- Magdy Mohamed Aly, Professor, Study director, Dean of Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338633
- Sponsor's protocol ID
- 314
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23657409
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain Reduction After Application of Three Intracanal Medicament Within Necrotic Root Canals and Pulp
- ClinicalTrials.gov ID
- NCT04338633
- Acronym / sponsor ID
- 314
- 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
- 8 Apr 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 conventional calcium hydroxide paste are assigned to group, Calcium hydroxide nanoparticle group and Combined Calcium hydroxide with silver nanoparticle group and record postoperative pain afterwards.
Detailed description
The investigator will recruit patients who are found eligible to the criteria, conventional calcium hydroxide paste , Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle . After 48 hours, patients will be randomly assigned to removal of intracanal medication
After the visit, patients will be asked to record post operative pain by Numerical Rating 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 |
|---|---|---|
| Conventional calcium hydroxide paste | Active comparator | Drug: Conventional calcium hydroxide pasteApplication of Conventional calcium hydroxide paste |
| Calcium hydroxide nanoparticle | Experimental | Drug: Calcium hydroxide nanoparticleApplication of Calcium hydroxide nanoparticle |
| Combined Calcium hydroxide with silver nanoparticle | Experimental | Drug: Combined Calcium hydroxide with silver nanoparticleApplication of Combined Calcium hydroxide with silver nanoparticle |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Medically free patients.
Key exclusion criteria (6 listed)
- • Teeth with unfavorable conditions for rubber-dam application.
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 |
|---|---|---|
| Conventional calcium hydroxide pasteAlso: UltracalConventional calcium hydroxide paste (Ultracal) will be removed in second visit. | Drug | Conventional calcium hydroxide paste |
| Calcium hydroxide nanoparticleCalcium hydroxide nanoparticle. manufactured in NanoTech. institute, will be removed in second visit. | Drug | Calcium hydroxide nanoparticle |
| Combined Calcium hydroxide with silver nanoparticleCombined Calcium hydroxide with silver nanoparticle will be removed in second visit. | Drug | Combined Calcium hydroxide with silver nanoparticle |
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 8 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.
- Individual participant dataSharing planned: No
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 Aly, Professor study director
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 Conventional calcium hydroxide paste, Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle 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 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 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 Mohamed Salah Hegazi (+201224014179, mshegazi2006@gmail.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 NCT04338633, which also lists 1 linked publication.
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 Apr 2020.