The Effect of Different Hemostatic Agents on Hemorrhage Control, Pain and Quality of Life After Endodontic Microsurgery.

NCT07311291 | Completed DMC

• 1 other identifier: 00272/2023
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background This randomized clinical trial evaluated the effect of two different hemostatic materials for endodontic microsurgery on bleeding control, postoperative pain and patients' quality of life. Methods Thirty-four subjects affected by apical periodontitis with clinical and radiographical indications for endodontic microsurgery were randomly divided into two groups: in the first group (n=15) a surgical glue was tested and in the second group (n=19) the ferric sulfate was used for hemostasis. The bleeding and the surgical field visibility during the intervention were evaluated. The postoperative pain and quality of life (QoL) was recorded through a numerical rating scale (NRS) and an Oral Health Impact Profile-14 (OHIP-14) questionnaire for seven days. The number of analgesics consumed during the same intervals was also recorded. Statistical analysis was performed using the Chi-Square test, Mann-Whitney test, and Fisher t-test (P=0.05).

Conditions

Endodontic Infection; Periapical Diseases

Keywords

endodontic microsurgery; surgical glue; ferric sulfate; cone-beam computed tomography; hemostatic agents

Outcome Measures

Primary Outcomes (1)

• Visual Hemorrhage Control (VHC)

  A questionnaire was given to the first, second and third operator. In the questionnaire it was asked to asses the Hemorrhage control with a scale from 0 (No control - worst outcome) to 4 (Total control - better outcome).

  perioperative

Secondary Outcomes (2)

• Postoperative pain

  7 days

• Quality of life (QoL)

  7 Days

Study Arms (1)

Apical Surgery

EXPERIMENTAL

Other: Hemostatic Agent 1: Surgical glue (IfaBond, Dipromed, Italy); Other: Hemostatic Agent 2: Ferric sulfate

Interventions

Hemostatic Agent 1: Surgical glue (IfaBond, Dipromed, Italy) OTHER

Hemostatic agents during apical surgery.

Apical Surgery

Hemostatic Agent 2: Ferric sulfate OTHER

Hemostatic agents during apical surgery

Apical Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive informed and consenting healthy subjects (ASA 1-2) of both genders with no medical history of systemic disease and presenting a diagnosis of symptomatic or asymptomatic apical periodontitis in correspondence of endodontically treated teeth with medium (2-5 mm3) and large (≥5 mm3) periapical lesions.
• Subjects with periapical defects with one or two residual cortical walls.
• Subjects with clinical indications for retrograde endodontic retreatment: teeth presenting inadequate root canal treatment with periapical radiolucency and impossible access through orthograde retreatment due to the presence of prosthetic restorations, posts, canal blocks and ledges.
• Subjects with teeth presenting an adequate coronal seal and absence of pathological periodontal records.

You may not qualify if:

• Subjects affected by diabetes mellitus.
• Subjects affected by hypertension.
• Subjects affected by hepatic or renal diseases.
• Subjects affected by bleeding disorders, antiplatelet or anticoagulant therapy.
• Women experiencing pregnancy.
• Subjects with teeth considered not restorable.
• Subjects with dental elements affected by fractures.
• Subjects with dental elements affected by extensive periodontal defects.
• Subjects with bone cavity designs with no residual cortical walls.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Dental School

Torino, Italy

Location

MeSH Terms

Conditions

Periapical Diseases

Interventions

Ifabond

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Damiano Pasqualini, Associate Professor

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

• Mario Alovisi, Associate Professor

  University of Turin, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 30, 2025
• Study Start: February 27, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)