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

NCT07529106 | Completed DMC

• 1 other identifier: FOUNCA09/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemostasis; Wound Closure; Pain; Extraction Socket Healing

Keywords

hemostatic sponges; tooth extraction; wound healing; postoperative complications; hemostasis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Hemostatic sponge

EXPERIMENTAL

The colocation of a hemostatic sponge post extraction in the wound

Procedure: Hemostatic sponge post tooth extraction

No intervention

NO INTERVENTION

No colocation of hemostatic sponge in the wound

Interventions

Hemostatic sponge post tooth extraction PROCEDURE

Effectiveness of hemostatic sponges in patients undergoing tooth extractions, analyzing immediate hemostasis and scar development at different postoperative times.

Hemostatic sponge

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Caaguazu: lead

Study Sites (1)

Universidad Nacional de Caaguazu

Coronel Oviedo, Caaguazú Department, 33000, Paraguay

Location

Related Publications (1)

• 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.

  PMID: 37510692 BACKGROUND

MeSH Terms

Conditions

Pain; Postoperative Complications

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Sofia Monzon, DDs

  Universidad Nacional de Caaguazu, Grupo Salud Oral y Biomateriales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statician in charge of data analysis was masked thorough codification of arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A sample of 30 patients was selected, divided into two groups of 15 patients each: an experimental group, which received treatment with hemostatic sponges, and a control group, which did not receive such treatment.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: April 14, 2026
• Study Start: August 8, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 30, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: On request
• Access Criteria: Other researchers

Locations

PA (1)