Postoperative PainNCT03350841
Pain After PRP Revascularization and Endodontic Treatment of Non-vital Mandibular Molars With Apical Periodontitis
A study testing Platelet rich plasma PRP and root canal treatment in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
randomized clinical trial which Evaluate thr Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars with Chronic Peri-apical Periodontitis Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Platelet rich plasma PRP and root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2018to Dec 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 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Medically free patients, between 18-40 years
- Patients with necrotic pulp in mandibular molar permanent teeth with closed apex
Who cannot join
- Illiterate patient
- Patients with systemic diseases
- Pregnant women
- Patients that have allergy to ciprofloxacin or metronidazole
- Teeth that:
- Have vertical root fracture, coronal perforation, and calcification.
Show all 9Show fewer
- re-treatment cases
- Non restorable
- Patients that have T.M.J. disorder
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Yassmin Elsayed Ahmed
Cairo
yassmin ahmed, 00201006088594, yassmin.ahmed@dentistry.cu.edu.eg
radwa emara, 00201272141312, radwa.emara@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization Versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars With Chronic Peri-apical Periodontitis
randomized clinical trial which Evaluate thr Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars with Chronic Peri-apical Periodontitis
Read the detailed description
it will be done in 2 visits where in the firist visit, i will finish cleaning and shaping of the canals and inject double antibiotic paste as intracanal medication.
in the second visit, removal of intracanal medication then obturaton of the canals in the control group. while in the intervention group,over instrumentation of the canals beyond the working length using k-file size 20-35 to establish bleeding in the canals.then blood sample is collected for PRP preparation then injected into the canal.the patient will record post operative pain 6,12,24,48 hours then 3,4,5 days later.then they will do CBCT at 6, 12 months after the treatment to assess peri-apical healing
- Conditions
- Postoperative Pain
- Being tested
- Platelet rich plasma PRP, root canal treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma PRPProcedure or surgery
blood sample is collected to prepare platelet rich plasma injected in the canal
root canal treatmentProcedure or surgery
conventional root canal treatment and obturation with guttapercha
| Study group | Role | What they receive |
|---|---|---|
| Revascularization | Experimental | platelet rich plasma injected in the canals Receives: Procedure: Platelet rich plasma PRP |
| root canal treatment | Active comparator | endodontic treatment obturated with gutta percha Receives: Procedure: root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain
postoperative pain evaluated using NRS scale It is a numerical rating scale from 0-10 with 0 representing no pain and 10 representing worst pain
Measured: 5 days
Secondary outcomes (1)
healing
healing of periapical tissue evaluated radiographically
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yassmin Elsayed Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350841
- Sponsor's protocol ID
- CEBD-CU-2017-11-27
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization Versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars With Chronic Peri-apical Periodontitis
- ClinicalTrials.gov ID
- NCT03350841
- Acronym / sponsor ID
- CEBD-CU-2017-11-27
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Nov 2017 (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.
randomized clinical trial which Evaluate thr Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars with Chronic Peri-apical Periodontitis
Detailed description
it will be done in 2 visits where in the firist visit, i will finish cleaning and shaping of the canals and inject double antibiotic paste as intracanal medication.
in the second visit, removal of intracanal medication then obturaton of the canals in the control group. while in the intervention group,over instrumentation of the canals beyond the working length using k-file size 20-35 to establish bleeding in the canals.then blood sample is collected for PRP preparation then injected into the canal.the patient will record post operative pain 6,12,24,48 hours then 3,4,5 days later.then they will do CBCT at 6, 12 months after the treatment to assess peri-apical healing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revascularization | Experimental | Procedure: Platelet rich plasma PRPplatelet rich plasma injected in the canals |
| root canal treatment | Active comparator | Procedure: root canal treatmentendodontic treatment obturated with gutta percha |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Medically free patients, between 18-40 years
- Patients with necrotic pulp in mandibular molar permanent teeth with closed apex
Key exclusion criteria (9 listed)
- Illiterate patient
- Patients with systemic diseases
- Pregnant women
- Patients that have allergy to ciprofloxacin or metronidazole
- Teeth that:
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 |
|---|---|---|
| Platelet rich plasma PRPblood sample is collected to prepare platelet rich plasma injected in the canal | Procedure or surgery | Revascularization |
| root canal treatmentconventional root canal treatment and obturation with guttapercha | Procedure or surgery | root canal treatment |
Primary outcome
Post-operative Pain
Time frame: 5 days
postoperative pain evaluated using NRS scale It is a numerical rating scale from 0-10 with 0 representing no pain and 10 representing worst pain
1 secondary outcome
healing
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma PRP and root canal treatment in people with Postoperative Pain, run by Cairo 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 2 inclusion and 9 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 2 Dec 2017. 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 yassmin ahmed (00201006088594, yassmin.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain (time frame: 5 days). 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 2 Dec 2017.