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

NCT ID: NCT06435832

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2024-06-01

Brief Summary

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.

Conditions

Alveolar Osteitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

just absorbable gelatin

After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.

Group Type: ACTIVE_COMPARATOR

Absorbable Gelatin

Intervention Type: DRUG

After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type: DRUG

After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

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.

Interventions

Absorbable Gelatin

After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.

Intervention Type: DRUG

Chlorhexidine

After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Recep Tayyip Erdogan University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Gumrukcu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Gümrükçü

Role: STUDY_DIRECTOR

Recep Tayyip Erdogan University

Locations

Recep Tayyip Erdoğan University

Rize, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Gumrukcu Z, Karabag M, Guven SE. The effects of chlorhexidine gel and tranexamic acid application after tooth extraction on the risk of alveolar osteitis formation: a double blind clinical study. Clin Oral Investig. 2024 Aug 21;28(9):494. doi: 10.1007/s00784-024-05886-x.

Reference Type: DERIVED

PMID: 39167305 (View on PubMed)

Other Identifiers

RTEUni

Identifier Type: -

Identifier Source: org_study_id