Evaluations of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence

Evaluation of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence

This intervention is the treatment of alveolar osteitis (alveolitis) with different effects, which occurs due to the formation of clot after extraction, which is one of the most common intervals after tooth extraction.98 healthy patients with molar and premolar teeth with indication for extraction were taken to the Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Oral and Maxillofacial Diseases and Surgery clinic between May 2024 and June 2024 (age: 38 sessions: 19). -62) 113 teeth (85 molar, 28 premolar teeth) were treated with Spongostan placed in the tooth socket after extraction, spongostan with Chlorhexidine gel and spongostan with tranexamic acid, randomly distributed. After extraction, alveolitis was observed and evaluated prospectively using spongostan, chlorhexidine gel and tranexamic acid in the dental sockets. The researcher checked the participants on the 3rd and 7th days after the tooth extraction. The researcher recorded the pain and edema levels by asking the participants between 0 and 10 using the Visual Analogue Scale (VAS). The researcher filled in the forms for the presence of halitosis, trismus and exposed bone socket on the 3rd and 7th days (YES-NO). Permanent analyzes of the study were created with the SPSS package program.

Study Overview

• Status: Active, not recruiting
• Conditions: Alveolar Osteitis
• Intervention / Treatment: Drug: Absorbable Gelatin; Drug: Chlorhexidine; Drug: Tranexamic acid

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53020
    • Recep Tayyip Erdogan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy individuals between the ages of 18-65
2. Molar and premolar teeth with extraction indication

Exclusion Criteria:

1. Against drugs or substances to be used in surgery (articaine, tranexamic acid, chlorhexidine) have allergies,
2. Those who used antibiotics 30 days before the dental extraction,

3. Clinical and radiological examinations in the operation area 30 days before dental extraction and/or on the day of the procedure.

   Any signs of pathology and infection (such as periapical pathology, pericoronitis),

4. Those who routinely use oral antiseptics,
5. Systemic fever, absence of growth such as lymphadenopathy (LAP),
6. Women are lactating or pregnant,
7. Using oral contraceptives,
8. Procedures that were not attended to control appointments (day 3-7) were not included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: just absorbable gelatin; After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.	Drug: Absorbable Gelatin; After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.
Active Comparator: absorbable gelatin with Chlorhexidine gel; After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.	Drug: Chlorhexidine; After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.
Active Comparator: absorbable gelatin with tranexamic acid; Tranexamic acid 50mg/ml for injection after saline irrigation after tooth extraction solution into gelatin sponges was applied to the socket after it was cured.	Drug: Tranexamic acid; Tranexamic acid 50mg/ml for injection after saline irrigation after tooth extraction solution into gelatin sponges was applied to the socket after it was cured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	scored on visual analog scale from 0 to 10	3.-7. days
edema	scored on visual analog scale from 0 to 10	3. day - 7. day
trismus	marked yes or no based on clinical examination	3. day - 7. day
halitosis	marked yes or no based on clinical examination	3. day - 7. day
alveolar osteitis	marked yes or no based on clinical examination	3. day - 7. day
smoking habit	marked yes or no based on anamnesis	operated day
age	marked yes or no based on anamnesis	operated day
tooth type	marked yes or no based on clinical examination	operated day

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University
• Investigators: Study Director: Zeynep Gümrükçü, Recep Tayyip Erdogan University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Estimated): May 26, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Alveolar Osteitis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Osteitis; Dry Socket; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Disinfectants; Tranexamic Acid; Chlorhexidine
• Other Study ID Numbers: RTEUni

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