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

NCT06435832 | Active Not Recruiting

• 1 other identifier: RTEUni
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Keywords

Alveolar Osteitis

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

just absorbable gelatin

ACTIVE COMPARATOR

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

Drug: Absorbable Gelatin

absorbable gelatin with Chlorhexidine gel

ACTIVE COMPARATOR

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

Drug: Chlorhexidine

absorbable gelatin with tranexamic acid

ACTIVE COMPARATOR

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

Interventions

Absorbable Gelatin DRUG

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

just absorbable gelatin

Chlorhexidine DRUG

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

absorbable gelatin with Chlorhexidine gel

Tranexamic acid 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.

absorbable gelatin with tranexamic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Against drugs or substances to be used in surgery (articaine, tranexamic acid, chlorhexidine) have allergies,
• Those who used antibiotics 30 days before the dental extraction,
• 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),
• Those who routinely use oral antiseptics,
• Systemic fever, absence of growth such as lymphadenopathy (LAP),
• Women are lactating or pregnant,
• Using oral contraceptives,
• Procedures that were not attended to control appointments (day 3-7) were not included.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University

Rize, 53020, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39167305 DERIVED

MeSH Terms

Conditions

Dry Socket

Interventions

Gelatin Sponge, Absorbable; Chlorhexidine; Tranexamic Acid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies; Biguanides; Guanidines; Amidines; Organic Chemicals; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Zeynep Gümrükçü

  Recep Tayyip Erdogan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: May 16, 2024
• Primary Completion: May 26, 2024
• Study Completion: June 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

TU (1)