Efficacy of sub-mucosal injection of chymotrypsin, oral serratiopeptidase and oral corticosteroids for reduction postoperative complications following impacted lower third molars surgery: a prospective, randomized, double-blinded, controlled clinical trial

• Register: TCTR
• Last refreshed on: 30 August 2021
• Main ID: TCTR20200828006
• Date of registration: 28/08/2020
• Prospective Registration: No
• Primary sponsor: Faculty of Dentistry, University of Technology
• Public title: Efficacy of sub-mucosal injection of chymotrypsin, oral serratiopeptidase and oral corticosteroids for reduction postoperative complications following impacted lower third molars surgery: a prospective, randomized, double-blinded, controlled clinical trial
• Scientific title: Efficacy of sub-mucosal injection of chymotrypsin, oral serratiopeptidase and oral corticosteroids for reduction postoperative complications following impacted lower third molars surgery: a prospective, randomized, double-blinded, controlled clinica
• Date of first enrolment: 27/08/2014
• Recruitment status: Completed
• URL: www.thaiclinicaltrials.org/show/TCTR20200828006
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 4

Countries of recruitment

yemen

Contacts

• Name: Essam almoraissi
• Affiliation: Thamar University

• Name: Essam almoraissi
• Affiliation: Thamar University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Adult healthy patients who were American Society of Anesthesiologists (ASA) group I and required surgical extraction of unilateral or bilateral complete impacted mandibular third molars.
2. All subjects had to presented with the same surgical difficulty concerning similar bone impaction and had the same classification in relation to the occlusal surface of the neighboring second molar (Class B: the impacted teeth are partly buried in the bone, or the occlusal plane of the impacted tooth is between the occlusal plane and the neighboring tooth's cervical line).

Exclusion criteria: 1. Patient administered other drugs such as NSAIDS and steroids.
2. Patient has allergy to the drugs used in this study.
3. Pregnant patient or a patient with lactation.
4. Immunocompromized patients with diabetic or hypertension (from patient’s history).
5. Patients with irradiated maxillofacial region.
6. Mentally challenged patients and patients unable to come for follow up visits.
7. patients with acute and subacute pericoronitis


Age minimum: 18 Years
Age maximum: 39 Years
Gender: Both

Health Condition(s) or Problem(s) studied

1. Adult healthy patients who were American Society of Anesthesiologists (ASA) group I and required surgical extraction of unilateral or bilateral complete impacted mandibular third molars.
lower third molar surgery ; oral corticosteroids ; chymotrypsin; oral serratiopeptidase

lower third molar surgery ; oral corticosteroids ; chymotrypsin; oral serratiopeptidase

Intervention(s)

Experimental Drug,Active Comparator Drug,Experimental Drug

oral serratiopeptidase ,oral corticosteroids ,Chymotrypsin group

Oral serratiopeptidase group : consisting of 20 patients who received 10 mg oral serratiopeptidase (Cipzen Forte) at immediate post-operative time and twice a day for post-operative five days; ,Dexamethasone group: consisting of 20 patients who received 8 mg oral corticosteroids (Dexamethasone) at immediate post-operative time and twice a day for post-operative five days. ,Chymotrypsin group : consisting of 20 patients who received pre-operative sub-mucosal injection of 5 mg chymotrypsin (Alfa Chymotrypsin) at pterygo-mandibular space following the inferior alveolar nerve block

Primary Outcome(s)

pain and facial swlling 2 days, 3 days and 5 days visual analaoque sacle

Secondary Outcome(s)

mouth opening day tape methods in millimeters

Source(s) of Monetary Support

Faculty of Dentistry, University of Technology

Ethics review

Status: Submitted, approved
Approval date:
Contact:

[e-mail]

Scientific Research ethic Committee

[phone] Ext.

[e-mail]

Results

• Date Completed: 01/12/2014