NCT07243210

Effect of Irrigation Solution Temperature on Clinical Outcomes and Salivary CRP After Impacted Mandibular Third Molar Surgery

Effect of Irrigation Solution Temperature on Clinical Outcomes and Salivary CRP After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Surgical extraction of impacted mandibular third molars often requires bone removal using rotary instruments, in which friction between the bur and bone generates heat. Excessive temperature rise may lead to local bone necrosis, delayed healing, and increased postoperative complications. Continuous irrigation with saline solution is routinely performed to reduce heat generation, and cold saline irrigation (0-4℃) has been shown to provide better thermal control than room-temperature saline. This study aims to evaluate the effect of cold saline irrigation compared with room-temperature saline irrigation on postoperative outcomes following impacted mandibular third molar surgery. The assessed parameters include pain, swelling, trismus, and salivary C-reactive protein (CRP) levels as a biomarker of inflammation. Salivary CRP serves as a minimally invasive marker that reflects the systemic inflammatory response after surgery. This randomized controlled trial will be conducted at the University of Medicine and Pharmacy at Ho Chi Minh City. Eligible patients with bilateral impacted mandibular third molars will be enrolled. Each patient will undergo extraction of one tooth with cold saline irrigation (0-4℃) and the contralateral tooth with room-temperature saline irrigation. Postoperative outcomes will include pain intensity (VAS) on days 1, 2, and 7; facial swelling on days 1, 2, and 7; trismus on days 1, 2, and 7; and salivary CRP levels at baseline and postoperative day 2. The findings are expected to clarify the role of irrigation solution temperature in both subjective clinical outcomes and objective inflammatory markers, thereby providing evidence to optimize clinical protocols and reduce postoperative morbidity in third molar surgery.

Conditions

• Third Molar Surgery
• Postoperative Complications
• C-REACTIVE PROTEIN

Interventions

Type	Name	Description
PROCEDURE	Cold Saline Irrigation	During surgical extraction of impacted mandibular third molars, bone removal and irrigation will be performed using sterile saline cooled to 0-4°C to minimize heat generation
PROCEDURE	Room-Temperature Saline Irrigation (Control)	During surgical extraction of impacted mandibular third molars, bone removal and irrigation will be performed using sterile saline at room temperature (approximately 25°C). This procedure serves as the control to compare the effects of irrigation temperature on postoperative outcomes.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2025-11-21
• Last updated: 2025-11-25

Locations

1 site across 1 country: Vietnam