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

NCT04585438 | Unknown Phase 4

• 1 other identifier: ENDO:3-5-5
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Irreversible Pulpitis; Postoperative Pain

Outcome Measures

Primary Outcomes (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.

  During endodontic treatment

Secondary Outcomes (1)

• Intensity of postoperative pain

  at 6, 12, 24, 48 hours after the end of endodontic treatment.

Study Arms (2)

Single trans-mucosal bio-adhesive disc containing Diclofenac Potassium

EXPERIMENTAL

Premedication 1 hour before starting endodontic treatment.

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)

Drug: Diclofenac Potassium

Interventions

Diclofenac Potassium DRUG

The drug will be used as a transparent disc applied to the mucosa

Also known as: Cataflam

Placebo Control; Single trans-mucosal bio-adhesive disc containing Diclofenac Potassium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• No restorability: Hopeless tooth.
• Immature teeth.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Allocation sequence generation: The co-supervisor who will assign the participants to either groups and will be the only one to know whether A or B represents the intervention or the control group. The principal investigator will enroll according to the previously mentioned eligibility criteria. The participant will drag an envelope and will be given a number. The patient will be allocated to either intervention or control group after contacting the co-supervisor to reveal the assigned group of the current patient according to the generated random sequence. The patient and the operator will not know the intervention done. The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmed Yousef Soliman

Model Details: Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: September 21, 2021
• Primary Completion: September 21, 2022
• Study Completion: September 22, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-10