Post-operative PainNCT03591172
Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization
A study testing Propolis, Nano-propolis and saline in people with Post-operative Pain, run by Cairo University.
Trial summary
this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Propolis, Nano-propolis and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Sep 2019
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- mature teeth.
- teeth with periapical periodontitis.
- Maxillary anterior teeth
- Patients should be free from any systemic disease
- Patients who will agree to the consent and will commit to follow-up period.
Who cannot join
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling. .Pregnant females. .Patients who could/would not participate in a 1-year follow-up. .Patients with fistula. .Patients with old age. .Teeth with periodontal involvement. .Teeth with vertical root fractures. .Non-restorable teeth.
About this study
Official title: Assessment of Implementing Nano-technology in the Irrigation Protocol of One Step Revascularization For Necrotic Mature Teeth
this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.
Read the detailed description
Nano-propolis and Propolis will be used as final endodontic irrigants and will be compared to saline in Revascularization of necrotic mature teeth.
- Conditions
- Post-operative Pain
- Being tested
- Propolis, Nano-propolis, saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropolisDrug
Also called natural irrigant
Using propolis as a final irrigation in revascularization
Nano-propolisDrug
Also called Natural irrigant
Using Nano-propolis as a final irrigation in revasculariztion
salineDrug
Also called sodium chloride
Using saline as a final irrigation in revasculariztion
| Study group | Role | What they receive |
|---|---|---|
| propolis | Experimental | natural antibacterial, anti-inflammatory irrigation solution Receives: Drug: Propolis |
| Nano-propolis | Experimental | natural antibacterial, anti-inflammatory irrigation solution Receives: Drug: Nano-propolis |
| saline | Active comparator | sodium chloride irrigation solution Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain: Visual analogue scale
post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.
Measured: 1 year
Secondary outcomes (3)
periapical healing
evaluated radiographically
Measured: 1 year
sensitivity
electric pulp tester
Measured: 1 year
survival
clinical evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Ahmed Nassar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591172
- Sponsor's protocol ID
- CEBD_CU_2018_05_29
- Status last verified
- May 2018
- First submitted
- 26 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Implementing Nano-technology in the Irrigation Protocol of One Step Revascularization For Necrotic Mature Teeth
- ClinicalTrials.gov ID
- NCT03591172
- Acronym / sponsor ID
- CEBD_CU_2018_05_29
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Jul 2018 (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.
this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.
Detailed description
Nano-propolis and Propolis will be used as final endodontic irrigants and will be compared to saline in Revascularization of necrotic mature teeth.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propolis | Experimental | Drug: Propolisnatural antibacterial, anti-inflammatory irrigation solution |
| Nano-propolis | Experimental | Drug: Nano-propolisnatural antibacterial, anti-inflammatory irrigation solution |
| saline | Active comparator | Drug: salinesodium chloride irrigation solution |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- mature teeth.
- teeth with periapical periodontitis.
- Maxillary anterior teeth
- Patients should be free from any systemic disease
- Patients who will agree to the consent and will commit to follow-up period.
Key exclusion criteria (3 listed)
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling. .Pregnant females. .Patients who could/would not participate in a 1-year follow-up. .Patients with fistula. .Patients with old age. .Teeth with periodontal involvement. .Teeth with vertical root fractures. .Non-restorable teeth.
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 |
|---|---|---|
| PropolisAlso: natural irrigantUsing propolis as a final irrigation in revascularization | Drug | propolis |
| Nano-propolisAlso: Natural irrigantUsing Nano-propolis as a final irrigation in revasculariztion | Drug | Nano-propolis |
| salineAlso: sodium chlorideUsing saline as a final irrigation in revasculariztion | Drug | saline |
Primary outcome
post-operative pain: Visual analogue scale
Time frame: 1 year
post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.
3 secondary outcomes
periapical healing
Time frame: 1 year
sensitivity
Time frame: 1 year
survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis, Nano-propolis and saline in people with Post-operative Pain, run by Cairo University.
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 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: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
post-operative pain: Visual analogue scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2018.