Effective Hemostasis: An Analysis of Hemostatic Sponges Used in Extraction Procedures

Tooth extraction is a common dental procedure, where hemostasis is crucial for patient recovery. This study evaluates the effectiveness of hemostatic sponges in controlling bleeding and promoting postoperative healing.

Study Overview

• Status: Completed
• Conditions: Pain; Hemostasis; Wound Closure; Extraction Socket Healing
• Intervention / Treatment: Procedure: Hemostatic sponge post tooth extraction

Detailed Description

A non-randomized experimental study was conducted at the Santo Tomás de Aquino School of Dentistry Clinic with 30 patients undergoing tooth extractions. They were divided into two groups: one with hemostatic sponges (experimental) and the other without (control). Variables such as bleeding time, wound depth, pain, and postoperative complications at 1, 8, and 15 days were analyzed.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Caaguazú Department
    • Coronel Oviedo, Caaguazú Department, Paraguay, 33000
      • Universidad Nacional de Caaguazú

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 18 years of age who underwent tooth extractions at the Santo Tomás de Aquino School of Dentistry clinic.
• Teeth to be extracted, both upper and lower.
• Diagnosis of pulp necrosis or irreversible pulpitis, with no possibility of endodontic treatment, impacted teeth, or periodontal disease.

Exclusion Criteria:

• Cancer patients undergoing radiotherapy or chemotherapy.
• Smokers and alcoholics.
• Patients who were uncooperative or did not attend follow-up appointments.
• Patients who did not respond to follow-up calls.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemostatic sponge; The colocation of a hemostatic sponge post extraction in the wound	Procedure: Hemostatic sponge post tooth extraction; Effectiveness of hemostatic sponges in patients undergoing tooth extractions, analyzing immediate hemostasis and scar development at different postoperative times.
No Intervention: No intervention; No colocation of hemostatic sponge in the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-tooth extraction hemostasis.	Time measured in minutes from the end of the extraction procedure until complete bleeding cessation, assessed by direct clinical observation.	From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Wound dimensional changes	Measurement of socket length, width, and depth using calibrated periodontal probe. Data will be reported as mean change in millimeters from baseline measurement.	From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Pain intensity	Pain intensity measured using Visual Analog Scale (VAS). Higher scores indicate worse outcome.	From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Edema assessment	Edema assessed by clinical examination using a 4-point scale: 0 = no edema, 1 = mild edema, 2 = moderate edema, 3 = severe edema. Higher scores indicate worse outcome.	From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Tissue color changes evaluation	Evaluation of tissue color changes using a standardized 5-point wound healing color scale: 1 = normal pink, 2 = pale pink, 3 = red, 4 = dark red/purple, 5 = black/necrotic. Higher scores indicate worse healing.	From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15
Post-extraction complications	Incidence of post-extraction complications including but not limited to: dry socket, infection, delayed healing, excessive bleeding, and nerve damage. Complications will be assessed by clinical examination and participant reporting.	From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15

Collaborators and Investigators

• Sponsor: Universidad Nacional de Caaguazu
• Investigators: Principal Investigator: Sofia Monzon, DDs, Universidad Nacional de Caaguazu, Grupo Salud Oral y Biomateriales

Publications and helpful links

General Publications

• Mahmoudi A, Ghavimi MA, Maleki Dizaj S, Sharifi S, Sajjadi SS, Jamei Khosroshahi AR. Efficacy of a New Hemostatic Dental Sponge in Controlling Bleeding, Pain, and Dry Socket Following Mandibular Posterior Teeth Extraction-A Split-Mouth Randomized Double-Blind Clinical Trial. J Clin Med. 2023 Jul 10;12(14):4578. doi: 10.3390/jcm12144578.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: wound healing; hemostasis; postoperative complications; tooth extraction; hemostatic sponges
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Postoperative Complications
• Other Study ID Numbers: FOUNCA09/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request
• IPD Sharing Time Frame: On request
• IPD Sharing Access Criteria: Other researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No