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Completed

NCT Number: NCT07529106

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Nacional de Caaguazu

Coronel Oviedo, Caaguazú Department, 33000, Paraguay

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Post-tooth extraction hemostasis.

    Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15

    Time measured in minutes from the end of the extraction procedure until complete bleeding cessation, assessed by direct clinical observation.

  2. Wound dimensional changes

    Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15

    Measurement of socket length, width, and depth using calibrated periodontal probe. Data will be reported as mean change in millimeters from baseline measurement.

  3. Pain intensity

    Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15

    Pain intensity measured using Visual Analog Scale (VAS). Higher scores indicate worse outcome.

  4. Edema assessment

    Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15

    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.

  5. Tissue color changes evaluation

    Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15

    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.

  6. Post-extraction complications

    Time frame: From the beggining of the treatment inmediatly, then at day 1, day 8, and at day 15

    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.

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Caaguazu

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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