The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain

NCT06298383 | Completed DMC

• 1 other identifier: ERU1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief Summary

Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (2)

• Success of Anesthesia

  Success of Inferior alveolar Nerve block anesthesia will be measured by recording the patient's pain severity before and after anesthesia administration as well as during endodontic procedures. each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.

  through study completion "an average of 1 year"

• Post-operative pain

  postoperative pain as recorded by the patient after completion of treatment in on visit. patient will receive a pain diary to record their postoperative pain incidence and severity at 6, 12, 24, 72 hours and 7 days after endodontic treatment. Each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.

  through study completion "an average of 1 year"

Study Arms (4)

Trypsin, Bromelain and Rutoside (TBR) Group

EXPERIMENTAL

patients will receive Trypsin, Bromelain and Rutoside combination (2 tablets of flamogen a combination of Trypsin 48mg, Bromelain 90mg and Rutoside 100mg) as a single oral dose 1 hour before treatment.

Drug: Trypsin, Bromelain and Rutoside

NSAIDs Group

ACTIVE COMPARATOR

Patients will receive diclofenac potassium (50mg) as a single oral dose 1 hour before treatment.

Drug: Diclofenac Potassium

Steroid Group

ACTIVE COMPARATOR

Patients will receive a single oral dose of a steroid drug (30 mg prednisolone) 1 hour before treatment.

Drug: Prednisolone Oral Tablet

Placebo group

PLACEBO COMPARATOR

Patients will receive a single oral dose of placebo (compressed tablets of powdered milk) 1 hour before treatment

Other: Placebo

Interventions

Diclofenac Potassium DRUG

Non-steroidal anti inflammatory drug. cataflam is known for its potent anti inflammatory and analgesic properties. each patient will receive one tablet of cataflam 50 mg 1 hour before treatment.

Also known as: Cataflam

NSAIDs Group

Prednisolone Oral Tablet DRUG

Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 30 mg solupred one hour before treatment

Also known as: solupred

Steroid Group

Placebo OTHER

A tablet of Compacted powdered milk

Placebo group

Trypsin, Bromelain and Rutoside DRUG

Flamogen is a combination of trypsin 48 mgs, bromelain 90mg and rutoside 100 mg in one tablet that provides an anti inflammatory, anti edematous activity. each patient will receive a single dose of 2 tablets one hour before treatment.

Also known as: Flamogen

Trypsin, Bromelain and Rutoside (TBR) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic irreversible pulpitis.
• Patients with active pain (moderate-to-severe) in mandibular molars.
• Males and females.
• Patient with the ability to understand and use pain scales.
• Patient who accepts to enroll to the study

You may not qualify if:

• Patients' allergies or any other contraindication to any of the used medications or mepivacaine.
• Pregnant and lactating females.
• Patients have been taking pain medication 12 hours earlier.
• Patient has more than one symptomatic mandibular tooth in the same quadrant.
• Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
• Patients with contributory medical history (ASA\>II).

Sponsors & Collaborators

• Cairo University: lead
• Egyptian Russian University: collaborator

Study Sites (2)

Faculty of Oral and Dental Medicine, Egyptian Russian University

Cairo, Cairo Governorate, 11829, Egypt

Location

Faculty of Dentistry, Cairo University

Cairo, 4450113, Egypt

Location

MeSH Terms

Interventions

Trypsin; Bromelains; Rutin; Diclofenac; Prednisolone

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Cysteine Endopeptidases; Cysteine Proteases; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Maha Nasr

  Egyptian Russian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 7, 2024
• Study Start: June 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: April 20, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)