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
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2024-09-15
2025-02-17
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Non-Steroidal Anti-inflammatory drug (Cataflam 50mg)
Received Cataflam
Cataflam® 50 coated tablet
of Cataflam 50 mg as part of their treatment protocol
Inferior alveolar nerve block only
received Inferior alveolar nerve block only
No interventions assigned to this group
Oral Tablets of Limitless Allzyme
Limitless Allzyme
Received Limitless Allzyme Max® Trypsin/Chymotrypsin/Bromelain(15 microkatal/42microkatal/240 GDU)
Alphintern® (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)
Oral tablets of Alphintern®
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)
Oral tablets of Alphintern®
received (Trypsin/Chymotrypsin 5 micro Katals/14 micro Katals)
Cataflam® 50 coated tablet
of Cataflam 50 mg as part of their treatment protocol
Eligibility Criteria
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Inclusion Criteria
* Both male and female participants were accepted.
* Mandibular molars diagnosed with acute irreversible pulpitis.
* Class I occlusion with normal occlusal contacts
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Ain Shams University
Cairo, Egypt, Egypt
Countries
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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.
Other Identifiers
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FDASU-RecIM012370
Identifier Type: -
Identifier Source: org_study_id
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