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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Show all 9Show fewer
  • 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.

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 groups in NCT04585438
Study groupRoleWhat they receive
Single trans-mucosal bio-adhesive disc containing Diclofenac PotassiumExperimentalPremedication 1 hour before starting endodontic treatment.
Receives: Drug: Diclofenac Potassium
Placebo ControlPlacebo comparatorPremedication 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.

  1. 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)
  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.

  1. First posted14 Oct 2020
  2. Study start21 Sep 2021 (estimated)
  3. Primary completion21 Sep 2022 (estimated)
  4. Study completion22 Sep 2022 (estimated)

Resources

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)
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

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.

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