Irreversible PulpitisPhase 4NCT04585438
Evaluation of Trans-mucosal Bio-adhesive Discs of Diclofenac Potassium on the Anesthetic Success and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
A Phase 4 study testing Diclofenac Potassium in people with Irreversible Pulpitis and Postoperative Pain, run by Cairo University.
Trial summary
The aim of the proposed study is to compare the effect of single dose of Diclofenac Potassium premedication as trans-mucosal bio-adhesive discs versus placebo on the effectiveness of the inferior alveolar nerve block and postoperative pain in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Postoperative Pain
- What is being tested?
- Diclofenac Potassium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2021to 22 Sep 2022
- Phase
- Phase 4
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Age between 18-50 years old.
- Males \& Females.
- Mandibular permanent molar teeth with:
- Preoperative sharp pain.
- Positive response of pulp tissue to cold pulp tester (ethyl chloride spray ) and electric pulp tester
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- Normal periapical radiographic appearance or slight widening in lamina dura using periapical index (PAI) score 1 as normal periapical structures or 2 as small changes in bone structures.
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
Who cannot join
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
- Teeth with necrotic pulp, acute periapical abscess and swelling: Need special treatment steps, it could influence initiation and progression of postoperative pain.
- Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
Show all 9Show fewer
- No restorability: Hopeless tooth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
About this study
The aim of the proposed study is to compare the effect of single dose of Diclofenac Potassium premedication as trans-mucosal bio-adhesive discs versus placebo on the effectiveness of the inferior alveolar nerve block and postoperative pain in patients with symptomatic irreversible pulpitis.
Read the detailed description
One of the challenging goals of root canal therapy is to relieve the pain associated with irreversible pulp inflammation. Pain control especially in the early stages of treatment, is critical and can enhance the confidence of both the patient and the dentist. Irreversible pulpitis pain is sometimes difficult to be managed through the use of local anesthetics solely. Inadequate pain control during treatment may contribute to the development of peripheral and central sensitization leading to greater pain during recovery. Various mechanisms have been proposed to explain the failure of local anesthetics including anatomic variations such as; cross innervations and accessory innervations, tachyphylaxis of anesthetic solutions, and activation of nociceptors including tetrodotoxin (TTX).Strategies to control intra-operative endodontic pain include preoperative administration of analgesics, supplemental infiltrations, the use of different local anesthetic solutions, intra-osseous and periodontal injections, a repeat inferior alveolar nerve block. Prescribing drugs prior to treatment may enhance the patient's attitude and reduce the apprehension during endodontic therapy. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most common category of medications recommended for pain relief. They act by inhibition of prostaglandin synthesis by inhibition of cyclooxygenase pathway. Although, pulpectomy and removal of the inflamed pulpal tissues eliminates endodontic pain, post-operative pain and discomfort are common side effects. Many patients may still experience mild to extreme pain even after therapy. Diclofenac has shown a substantial reduction of post-endodontic pain when administered preoperatively in a single oral dose since it holds anti-inflammatory, antipyretic and analgesic effects. It acts primarily by inhibition of COX 1 and COX 2, thus inhibiting the prostaglandin synthesis. COX 1 is expressed throughout the body and has a role in protection of stomach mucosa, kidney function and platelet action. Numerous studies have clearly documented that the risk of upper gastrointestinal complications increases with increasing doses as well as increasing frequency of use. Additionally, when taken through oral route, only 50% of the absorbed dose of Diclofenac becomes available systematically, due to its first pass metabolism. Trans-mucosal drug delivery offers distinct advantages over oral administration such as avoiding hepatic first-pass metabolism, less dosing frequency, improved patient compliance, reduction in fluctuation in steady-state levels. In addition, there is a reduced intensity of local or systemic side effects, increased safety margin and maximum utilization of drug and reduction in the total amount of drug administered while achieving target delivery in odontogenic region.
- Conditions
- Irreversible Pulpitis, Postoperative Pain
- Being tested
- Diclofenac Potassium
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac PotassiumDrug
Also called Cataflam
The drug will be used as a transparent disc applied to the mucosa
| Study group | Role | What they receive |
|---|---|---|
| Single trans-mucosal bio-adhesive disc containing Diclofenac Potassium | Experimental | Premedication 1 hour before starting endodontic treatment. Receives: Drug: Diclofenac Potassium |
| Placebo Control | Placebo comparator | Premedication 1 hour before starting endodontic treatment. Identically-appearing trans-mucosal bio-adhesive disc (Does not contain medication) Receives: Drug: Diclofenac Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the inferior alveolar nerve block during cold test or any stage of access cavity preparation or instrumentation in patients with irreversible pulpitis.
the outcome will be measured with Heft-parker visual analogue scale (VAS) in which no or mild pain (Heft-Parker VAS rating less than 54mm) will be considered as anesthetic success and moderate or severe pain (Heft-parker VAS rating greater than 54mm) will be considered as anesthetic failure.
Measured: During endodontic treatment
Secondary outcomes (1)
Intensity of postoperative pain
the outcome will be measured using Heft-parker VAS
Measured: at 6, 12, 24, 48 hours after the end of endodontic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start21 Sep 2021 (estimated)
- Primary completion21 Sep 2022 (estimated)
- Study completion22 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yousef Soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585438
- Sponsor's protocol ID
- ENDO:3-5-5
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trans-mucosal Bio-adhesive Discs of Diclofenac Potassium on the Anesthetic Success and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04585438
- Acronym / sponsor ID
- ENDO:3-5-5
- Conditions
- Irreversible Pulpitis, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Sep 2021 (estimated)
- Primary completion
- 21 Sep 2022 (estimated)
- Study completion
- 22 Sep 2022 (estimated)
- First posted
- 14 Oct 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.
The aim of the proposed study is to compare the effect of single dose of Diclofenac Potassium premedication as trans-mucosal bio-adhesive discs versus placebo on the effectiveness of the inferior alveolar nerve block and postoperative pain in patients with symptomatic irreversible pulpitis.
Detailed description
One of the challenging goals of root canal therapy is to relieve the pain associated with irreversible pulp inflammation. Pain control especially in the early stages of treatment, is critical and can enhance the confidence of both the patient and the dentist. Irreversible pulpitis pain is sometimes difficult to be managed through the use of local anesthetics solely. Inadequate pain control during treatment may contribute to the development of peripheral and central sensitization leading to greater pain during recovery. Various mechanisms have been proposed to explain the failure of local anesthetics including anatomic variations such as; cross innervations and accessory innervations, tachyphylaxis of anesthetic solutions, and activation of nociceptors including tetrodotoxin (TTX).Strategies to control intra-operative endodontic pain include preoperative administration of analgesics, supplemental infiltrations, the use of different local anesthetic solutions, intra-osseous and periodontal injections, a repeat inferior alveolar nerve block. Prescribing drugs prior to treatment may enhance the patient's attitude and reduce the apprehension during endodontic therapy. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most common category of medications recommended for pain relief. They act by inhibition of prostaglandin synthesis by inhibition of cyclooxygenase pathway. Although, pulpectomy and removal of the inflamed pulpal tissues eliminates endodontic pain, post-operative pain and discomfort are common side effects. Many patients may still experience mild to extreme pain even after therapy. Diclofenac has shown a substantial reduction of post-endodontic pain when administered preoperatively in a single oral dose since it holds anti-inflammatory, antipyretic and analgesic effects. It acts primarily by inhibition of COX 1 and COX 2, thus inhibiting the prostaglandin synthesis. COX 1 is expressed throughout the body and has a role in protection of stomach mucosa, kidney function and platelet action. Numerous studies have clearly documented that the risk of upper gastrointestinal complications increases with increasing doses as well as increasing frequency of use. Additionally, when taken through oral route, only 50% of the absorbed dose of Diclofenac becomes available systematically, due to its first pass metabolism. Trans-mucosal drug delivery offers distinct advantages over oral administration such as avoiding hepatic first-pass metabolism, less dosing frequency, improved patient compliance, reduction in fluctuation in steady-state levels. In addition, there is a reduced intensity of local or systemic side effects, increased safety margin and maximum utilization of drug and reduction in the total amount of drug administered while achieving target delivery in odontogenic region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
| Arm | Type | Receives |
|---|---|---|
| Single trans-mucosal bio-adhesive disc containing Diclofenac Potassium | Experimental | Drug: Diclofenac PotassiumPremedication 1 hour before starting endodontic treatment. |
| Placebo Control | Placebo comparator | Drug: Diclofenac PotassiumPremedication 1 hour before starting endodontic treatment. Identically-appearing trans-mucosal bio-adhesive disc (Does not contain medication) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Age between 18-50 years old.
- Males \& Females.
- Mandibular permanent molar teeth with:
Key exclusion criteria (9 listed)
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
- Teeth with necrotic pulp, acute periapical abscess and swelling: Need special treatment steps, it could influence initiation and progression of postoperative pain.
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 |
|---|---|---|
| Diclofenac PotassiumAlso: CataflamThe drug will be used as a transparent disc applied to the mucosa | Drug | Placebo Control, Single trans-mucosal bio-adhesive disc containing Diclofenac Potassium |
Primary outcome
Effectiveness of the inferior alveolar nerve block during cold test or any stage of access cavity preparation or instrumentation in patients with irreversible pulpitis.
Time frame: During endodontic treatment
the outcome will be measured with Heft-parker visual analogue scale (VAS) in which no or mild pain (Heft-Parker VAS rating less than 54mm) will be considered as anesthetic success and moderate or severe pain (Heft-parker VAS rating greater than 54mm) will be considered as anesthetic failure.
1 secondary outcome
Intensity of postoperative pain
Time frame: at 6, 12, 24, 48 hours after the end of endodontic treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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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 Phase 4 study testing Diclofenac Potassium in people with Irreversible Pulpitis and Postoperative 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 9 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 14 Oct 2020. 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. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness of the inferior alveolar nerve block during cold test or any stage of access cavity preparation or instrumentation in patients with irreversible pulpitis. (time frame: During endodontic treatment). 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 14 Oct 2020.