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A Comparison of Recovery After Impacted Wisdom Tooth Removal

NCT07304882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-26

No results posted yet for this study

Summary

Justification of the Study There is a high prevalence of impacted third molars, often accompanied by a range of postoperative complications. To the best of the researcher's knowledge, no clinical study to date has directly compared the efficacy of serratiopeptidase and escin in minimizing the most commonly observed postoperative complications following impacted mandibular third molar surgery. This study seeks to address this gap by providing empirical evidence that could contribute to optimizing postoperative care.

Objectives of the Study

Drawing from the background and research questions outlined above, the objectives of this study are divided into general and specific ones, outlined as follows:

General Objective To compare the efficacy of serratiopeptidase and escin, when used as adjuncts to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.

Specific Objectives

The study set the following specific objectives:

1. To evaluate the efficacy of serratiopeptidase, as an adjunct to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
2. To evaluate the efficacy of escin, as an adjunct to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.

Study Hypotheses The study formulated the following hypotheses

1. Serratiopeptidase, as an adjunct to conventional drugs, provides significantly greater efficacy than conventional drugs alone in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
2. Escin, as an adjunct to conventional drugs, provides significantly greater efficacy than conventional drugs alone in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
3. There is a statistically significant difference in the efficacy of serratiopeptidase compared to escin in reducing postoperative complications (i.e., trismus, facial edema, and pain) when both are used as adjuncts to conventional drugs following impacted mandibular third molar surgery.

Conditions

  • Impacted Mandibular Third Molar Extraction
  • Post Operative Complications

Interventions

DRUG

serratiopeptidase

10 mg oral serratiopeptidase , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg

DRUG

Escin

20 mg oral escin , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg

DRUG

Conventional drugs

Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg

Sponsors & Collaborators

  • University of Science and Technology, Yemen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-01-04
Completion
2025-01-04

Countries

  • Yemen

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304882 on ClinicalTrials.gov