A Comparison of Recovery After Impacted Wisdom Tooth Removal (CESE-3M)

University of Science and Technology, Yemen

Status and phase: Completed; Phase 3

Conditions: Impacted Mandibular Third Molar Extraction; Post Operative Complications

Treatments: Drug: Conventional drugs; Drug: Escin; Drug: serratiopeptidase

Study type: Interventional

Funder types: Other

Identifiers

NCT07304882

1445/0012/UREC/UST

ISRCTN15432618 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

This clinical trial employed a split-mouth design, wherein two different treatments were randomly assigned to opposite halves of each patient's mouth. The study was conducted as a triple-blind randomized trial to minimize bias and enhance scientific rigor. The procedures were carried out by the researcher; however, the operator was blinded to the evaluation data. The evaluator, who had access to patients' symptom responses, remained unaware of which treatment was administered on each side. Likewise, patients were blinded to the treatment or intervention applied to each side of their mouth.

Participants were allocated into two groups, with each patient serving as their own control through the split-mouth approach. On one side, an impacted mandibular third molar was extracted and treated with conventional medications. After a washout period of three weeks, the contralateral molar was extracted and treated with an additional intervention alongside the conventional drugs-either an enzyme or a herbal agent. The groups were defined as follows:

• The first group received conventional medications combined with 10 mg oral serratiopeptidase, administered immediately postoperatively and then thrice daily for five days following the first surgical visit. During the second visit (after three weeks), only conventional drugs were given, or vice versa.
• The second group received conventional medications combined with 20 mg oral escin, administered immediately postoperatively and then thrice daily for five days following the first surgical visit. At the second visit (after three weeks), only conventional drugs were administered, or vice versa.

The conventional medication administered to both groups consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medically healthy.
• Presence of two mandibular third molars indicated for surgical extraction.
• No history of pericoronitis or other signs of inflammation within the past 30 days.

Exclusion criteria

• Current use of other medications such as NSAIDs or corticosteroids.
• Known allergy to any drugs administered in this study.
• Pregnancy or breastfeeding.
• History of diabetes or hypertension.
• Previous irradiation to the maxillofacial region.
• Intellectual disability or inability to attend follow-up visits.
• Presence of acute or subacute pericoronitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

24 participants in 4 patient groups

Serratiopeptidase (Test 1)

Experimental group

Description:

This group received conventional medications combined with 10 mg oral serratiopeptidase, administered immediately postoperatively and then thrice daily for five days following the first surgical visit.

Treatment:

Drug: serratiopeptidase

Conventional medication (Control 1)

Active Comparator group

Description:

During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.

Treatment:

Drug: Conventional drugs

Escin (Test 2)

Experimental group

Description:

This group received conventional medications combined with 20 mg oral escin, administered immediately postoperatively and then thrice daily for five days following the first surgical visit

Treatment:

Drug: Escin

Conventional medication (Control 2)

Active Comparator group

Description:

During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.

Treatment:

Drug: Conventional drugs