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

NCT07243210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-11-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Vietnam

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 NCT07243210 on ClinicalTrials.gov