Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis

NCT ID: NCT07088042

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-02-17

Brief Summary

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The goal of this clinical trial is to assess the effect of preoperative

* Oral Tablets of Trypsin/Chymotrypsin/Bromelain Limitless Allzyme® (15 microkatal/42microkatal/240 GDU)
* Oral tablets of Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)
* Oral Tablets Non-Steroidal Anti-inflammatory drug (Cataflam® 50mg)

Regarding the efficacy of the inferior alveolar nerve block anesthesia in mandibular molars with symptomatic irreversible pulpitis and post operative pain follow up for 3 days.

The main question it aims to answer are: • Does premedication increase the success rate of inferior alveolar nerve block.

Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. Researchers will compare different premedication to see if it increases the success rate of inferior alveolar nerve block using Visual Analogue Scale (VAS), Electric Pulp testing and cavity test.

Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non-Steroidal Anti-inflammatory drug (Cataflam 50mg)

Received Cataflam

Group Type ACTIVE_COMPARATOR

Cataflam® 50 coated tablet

Intervention Type DRUG

of Cataflam 50 mg as part of their treatment protocol

Inferior alveolar nerve block only

received Inferior alveolar nerve block only

Group Type NO_INTERVENTION

No interventions assigned to this group

Oral Tablets of Limitless Allzyme

Group Type EXPERIMENTAL

Limitless Allzyme

Intervention Type DRUG

Received Limitless Allzyme Max® Trypsin/Chymotrypsin/Bromelain(15 microkatal/42microkatal/240 GDU)

Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)

Group Type ACTIVE_COMPARATOR

Oral tablets of Alphintern®

Intervention Type DRUG

received (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)

Interventions

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Limitless Allzyme

Received Limitless Allzyme Max® Trypsin/Chymotrypsin/Bromelain(15 microkatal/42microkatal/240 GDU)

Intervention Type DRUG

Oral tablets of Alphintern®

received (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)

Intervention Type DRUG

Cataflam® 50 coated tablet

of Cataflam 50 mg as part of their treatment protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* • From 18 to 65 years old.

* Both male and female participants were accepted.
* Mandibular molars diagnosed with acute irreversible pulpitis.
* Class I occlusion with normal occlusal contacts

Exclusion Criteria

* • Individuals with significant health issues: a history of gastrointestinal disorders, active bronchial asthma, renal diseases, liver dysfunction, heart diseases, blood disorders, hypertension or poorly controlled diabetes mellitus.

* Immunocompromised patients.
* Sensitivity or allergy to any of the pharmaceuticals or medications intended for use in the study
* Participants who could not read, comprehend, or complete the baseline pain scale questionnaire.
* Cases where clinical examination suggested necrotic teeth leading to a false positive diagnosis.
* Teeth exhibiting periodontal disease or periapical lesions confirmed through clinical assessment and pre-operative radiographs.
* Sensitivity to percussion or palpation in the included teeth
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University

Cairo, Egypt, Egypt

Site Status

Countries

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Egypt

References

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Hashem AAR, Abd El Sattar AA, Abdel Rahman TY. The Effect of Trypsin-Chymotrypsin on Postoperative Pain after Single Visit Endodontic Treatment: A Randomized Controlled Trial. J Endod. 2023 Mar;49(3):240-247. doi: 10.1016/j.joen.2022.12.010. Epub 2022 Dec 24.

Reference Type BACKGROUND
PMID: 36574828 (View on PubMed)

Other Identifiers

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FDASU-RecIM012370

Identifier Type: -

Identifier Source: org_study_id

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