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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06435832
Other study ID # RTEUni
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 16, 2024
Est. completion date June 1, 2024

Study information

Verified date May 2024
Source Recep Tayyip Erdogan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 98
Est. completion date June 1, 2024
Est. primary completion date May 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Absorbable Gelatin
After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.
Chlorhexidine
After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.
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.

Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain scored on visual analog scale from 0 to 10 3.-7. days
Primary edema scored on visual analog scale from 0 to 10 3. day - 7. day
Primary trismus marked yes or no based on clinical examination 3. day - 7. day
Primary halitosis marked yes or no based on clinical examination 3. day - 7. day
Primary alveolar osteitis marked yes or no based on clinical examination 3. day - 7. day
Primary smoking habit marked yes or no based on anamnesis operated day
Primary age marked yes or no based on anamnesis operated day
Primary tooth type marked yes or no based on clinical examination operated day
See also
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Completed NCT03641482 - NBF Gingival Gel Application After Impacted Lower Third Molar Surgery N/A
Recruiting NCT05615272 - Treatment of Alveolar Osteitis: Traditional or Regenerative? N/A
Not yet recruiting NCT05850650 - The Effect of Post-extraction Collagen Sponge Application on Alveolar Osteitis Phase 2
Recruiting NCT04853589 - Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis N/A
Completed NCT02382809 - Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction Phase 4
Completed NCT00118820 - Antibiotic Efficacy in Third Molar Surgery Phase 3
Completed NCT04151147 - Effect of CGF on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery N/A
Enrolling by invitation NCT04476121 - Use of PRF in Treatment of Dry Socket. N/A
Completed NCT04507009 - Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis N/A