Efficacy of Oral Serratiopaptidase Vs Dexamethasone on Post-Operative Inflammation After Exodontia. An Experience at Tertiary Care Hospital Karachi Pakistan.

NCT07785596 | Completed DMC

• 1 other identifier: KGH-ERB: 2025/ 011
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Rationale Exodontia, commonly referred to as tooth extraction, is one of the frequently performed procedures in dental and oral surgical practice. Although extraction is generally considered a routine procedure, the surgical manipulation of oral and dental tissues can produce a localized inflammatory response. This response may result in post-operative pain, facial or intraoral swelling, tenderness, discomfort, and temporary limitation of normal oral functions. The intensity of these manifestations can vary according to the type and complexity of the extraction, the extent of tissue manipulation, the duration of the procedure, and individual patient characteristics. Post-operative inflammation is a normal component of tissue healing. However, excessive or prolonged inflammation may negatively affect patient comfort and recovery. Effective control of post-operative inflammation is therefore an important component of dental care. Pharmacological interventions are frequently used to reduce inflammatory symptoms and improve the patient's post-operative experience. Corticosteroids, particularly dexamethasone, are commonly used for the prevention and management of post-operative inflammatory responses associated with oral surgical procedures. Dexamethasone has potent anti-inflammatory properties and acts through suppression of multiple inflammatory pathways. It can reduce inflammatory edema and other manifestations of the inflammatory response following surgical trauma. Because of its established anti-inflammatory effect, dexamethasone has been used in oral and maxillofacial surgery and in other surgical settings. Serratiopeptidase, also known as serrapeptase, is a proteolytic enzyme that has been investigated as an alternative approach for controlling post-operative inflammation and edema. It has been proposed to influence inflammatory processes and tissue edema through enzymatic activity and modulation of inflammatory exudates. Its use in dental practice has been investigated particularly in relation to post-operative swelling following oral surgical procedures. Previous clinical research has directly compared serratiopeptidase and dexamethasone for the control of post-operative swelling after surgical removal of impacted mandibular third molars. In one randomized study involving 100 participants, both interventions were evaluated for their ability to reduce post-operative swelling, with swelling assessed at multiple post-operative time points. The study reported reductions in swelling with both treatments, although the pattern of effect differed across the post-operative period. Despite existing evidence, further clinical evaluation may be useful because the effectiveness of an intervention can vary according to the patient population, type of dental procedure, clinical setting, prescribing practices, and methods used to assess post-operative inflammation. Evidence generated from a tertiary care hospital in Karachi, Pakistan, may provide locally relevant information regarding the comparative effectiveness of these two pharmacological approaches. Purpose of the Study The purpose of this study is to compare the role of oral serratiopeptidase with dexamethasone in controlling post-operative inflammation following exodontia among participants undergoing tooth extraction at a tertiary care hospital in Karachi, Pakistan. The study will assess whether oral serratiopeptidase provides a clinically useful alternative to dexamethasone for the management of post-operative inflammatory manifestations after exodontia. The principal hypothesis is that there will be a difference in the post-operative inflammatory response between participants receiving oral serratiopeptidase and those receiving dexamethasone following exodontia. Study Overview This study is designed as an interventional clinical trial comparing two pharmacological approaches for the management of post-operative inflammation following exodontia. Eligible participants undergoing exodontia at the study site will be assigned to receive either oral serratiopeptidase or dexamethasone according to the allocation procedure specified in the study protocol. The clinical response following the procedure will be assessed using predefined measures of post-operative inflammation. These may include clinical assessment of swelling, pain, tenderness, and other relevant post-operative inflammatory manifestations as specified in the study protocol. The study will compare the post-operative clinical course between the two treatment groups. The assessment will focus primarily on the extent and progression of post-operative inflammation and the overall recovery following exodontia. Study Population The study population will consist of participants undergoing exodontia at a tertiary care hospital in Karachi, Pakistan, who meet the predefined eligibility criteria. Participants will be assessed before enrollment to determine their eligibility for part

Conditions

Post-operative Inflammation Post-operative Pain Post-operative Swelling (Edema)

Keywords

Exodontia Tooth extraction Post-operative inflammation Post-operative swelling Post-operative pain Serratiopeptidase Serrapeptase Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Post-operative inflammation following exodontia

  "Change in post-operative inflammation between the serratiopeptidase and dexamethasone groups following exodontia, assessed using the predefined clinical measurement method."

  Primary objective • To compare the effect of oral serratiopeptidase versus oral dexamethasone on post-operative facial swelling following surgical exodontia at 72 hours. Secondary objectives • To compare post-operative pain (measured by VAS) at 6, 24, 48

Study Arms (2)

Serratiopeptidase Group

ACTIVE COMPARATOR

"Participants assigned to this arm will receive oral serratiopeptidase as the study intervention for the management of post-operative inflammation following exodontia, according to the dose and treatment schedule specified in the study protocol."

Drug: Arm 1:Serratiopeptidase Arm 2: Dexamethasone

Dexamethasone Group:

ACTIVE COMPARATOR

"Participants assigned to this arm will receive dexamethasone as the comparator intervention for the management of post-operative inflammation following exodontia, according to the dose and treatment schedule specified in the study protocol."

Drug: Arm 1:Serratiopeptidase Arm 2: Dexamethasone

Interventions

Arm 1:Serratiopeptidase Arm 2: Dexamethasone DRUG

Serratiopeptidase: "Oral serratiopeptidase administered after exodontia to reduce post-operative inflammation and associated swelling." Dexamethasone: "Oral dexamethasone administered after exodontia as an anti-inflammatory comparator to reduce post-operative inflammation and associated swelling."

Also known as: Serratiopeptidase, Dexamethasone

Dexamethasone Group:; Serratiopeptidase Group

Eligibility Criteria

• Age: 18 Weeks - 70 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 18-70 years
• non-restorable teeth \& no prior use of recent dexamethasone or serratiopaptidase.
• Able to provide informed consent and comply with follow-up.

You may not qualify if:

• The patient excluded are having co-morbids specifically diabetes mellitus, nephropathy and hypertension, hyperthyroidism, non-compliant,
• allergic to the dexamethasone or serratiopaptidase \&
• those who refuse to involve in study

Sponsors & Collaborators

• Kharadar General Hospital: lead

Study Sites (1)

Kgh

Karachi, Pakistan

Location

MeSH Terms

Conditions

Edema

Interventions

serratiopeptidase; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: January 1, 2025
• Primary Completion: January 1, 2025
• Study Completion: November 20, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

PA (1)