Symptomatic Irreversible PulpitisPhase 2/3NCT03335007
Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment
A Phase 2/3 study testing Aceclofenac in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Aceclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Jul 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in good health (American Society of Anesthesiologists Class I or Class II).
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age is 18 years or older.
- Patients who can understand Heft- Parker Visual Analogue Scales.
- Patients able to sign informed consent.
Who cannot join
- Patients allergic to aceclofenac or Mepivacaine.
- Pregnant or nursing women.
- Patients having active pain in more than one molar in the same quadrant.
- Administration of analgesics within 12 h before the administration of the study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment: A Randomized, Double-blind, Placebo-controlled Trial
The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal treatment.
Read the detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before the initiation of single-visit endodontic therapy. Each participant will receive a standard inferior alveolar nerve block injection of 1.8 ml of 2% mepivacaine with 1:100,000 epinephrine. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 24, and 48 hours postoperatively using Heft-Parker visual analogue scale (HP-VAS). Postoperative pain at injection area will be assessed at 6,24 and 48 hours using HP-VAS. Analgesic intake throughout the 48 hours will be recorded.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Aceclofenac, Placebo
- Keywords
- Aceclofenac, pain, irreversible pulpitis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AceclofenacDrug
Also called Bristaflam
Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
PlaceboOther
Placebo tablet given one hour before starting the root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Aceclofenac | Experimental | Aceclofenac 100 mg tablet Receives: Drug: Aceclofenac |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postendodontic pain rate change
Postendodontic pain will be measured using Heft-Parker visual analogue scale. No or mild pain response will be considered success.
Measured: At 6, 24 and 48 hours after root canal treatment.
Secondary outcomes (2)
Postoperative pain at injection area
Postoperative pain at injection area will be measured with Heft-Parker visual analogue scale. No or mild pain response will be considered success.
Measured: At 6, 24 and 48 hours after root canal treatment.
Analgesic intake
Incidence of analgesic intake
Measured: Within 48 hours after single root canal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startMay 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen AwadAllah Abbas Ibrahim, Cairo University
- Investigators
- Nermeen A Abbas, Postgraduate, Principal investigator, Cairo UniversitySuzan AW Amin, PhD, Study director, Cairo UniversityShaimaa Gawdat, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335007
- Sponsor's protocol ID
- CEBD-CU-2015-5-146
- Status last verified
- Nov 2017
- First submitted
- 29 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Praveen R, Thakur S, Kirthiga M. Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial. J Endod. 2017 May;43(5):667-673. doi: 10.1016/j.joen.2016.12.012. Epub 2017 Mar 17.
PubMed 28320541Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. J Endod. 2008 Jun;34(6):652-5. doi: 10.1016/j.joen.2008.02.017. Epub 2008 Apr 2.
PubMed 18498882
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03335007
- Acronym / sponsor ID
- CEBD-CU-2015-5-146
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Aceclofenac, pain, irreversible pulpitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 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.
The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal treatment.
Detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before the initiation of single-visit endodontic therapy. Each participant will receive a standard inferior alveolar nerve block injection of 1.8 ml of 2% mepivacaine with 1:100,000 epinephrine. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 24, and 48 hours postoperatively using Heft-Parker visual analogue scale (HP-VAS). Postoperative pain at injection area will be assessed at 6,24 and 48 hours using HP-VAS. Analgesic intake throughout the 48 hours will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aceclofenac | Experimental | Drug: AceclofenacAceclofenac 100 mg tablet |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in good health (American Society of Anesthesiologists Class I or Class II).
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age is 18 years or older.
- Patients who can understand Heft- Parker Visual Analogue Scales.
- Patients able to sign informed consent.
Key exclusion criteria (4 listed)
- Patients allergic to aceclofenac or Mepivacaine.
- Pregnant or nursing women.
- Patients having active pain in more than one molar in the same quadrant.
- Administration of analgesics within 12 h before the administration of the study drug.
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 |
|---|---|---|
| AceclofenacAlso: BristaflamAceclofenac 100 mg tablet given one hour before starting the root canal treatment | Drug | Aceclofenac |
| PlaceboPlacebo tablet given one hour before starting the root canal treatment | Other | Placebo |
Primary outcome
Postendodontic pain rate change
Time frame: At 6, 24 and 48 hours after root canal treatment.
Postendodontic pain will be measured using Heft-Parker visual analogue scale. No or mild pain response will be considered success.
2 secondary outcomes
Postoperative pain at injection area
Time frame: At 6, 24 and 48 hours after root canal treatment.
Analgesic intake
Time frame: Within 48 hours after single root canal treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 28320541Praveen R, Thakur S, Kirthiga M. Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial. J Endod. 2017 May;43(5):667-673. doi: 10.1016/j.joen.2016.12.012. Epub 2017 Mar 17.
- Background: PubMed 18498882Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. J Endod. 2008 Jun;34(6):652-5. doi: 10.1016/j.joen.2008.02.017. Epub 2008 Apr 2.
- Individual participant dataSharing planned: No
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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.
Nermeen A Abbas, Postgraduate principal investigator
Cairo University
Suzan AW Amin, PhD study director
Cairo University
Shaimaa Gawdat, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aceclofenac in people with Symptomatic Irreversible Pulpitis, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 7 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postendodontic pain rate change (time frame: At 6, 24 and 48 hours after root canal treatment.). 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 NCT03335007, which also lists 2 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 Nov 2017.