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Clinical Trials/NCT07529106
NCT07529106CompletedNot Applicable

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

Universidad Nacional de Caaguazu1 site in 1 country30 target enrollmentStarted: August 8, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Post-tooth extraction hemostasis.

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The statician in charge of data analysis was masked thorough codification of arms.

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Hemostatic sponge

Experimental

The colocation of a hemostatic sponge post extraction in the wound

Intervention: Hemostatic sponge post tooth extraction (Procedure)

No intervention

No Intervention

No colocation of hemostatic sponge in the wound

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Universidad Nacional de Caaguazu
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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