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Active, not recruitingNCT06435832Updated May 30, 2024

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

An interventional study of Absorbable Gelatin and Chlorhexidine in Alveolar Osteitis, sponsored by Recep Tayyip Erdogan University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by Recep Tayyip Erdogan University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alveolar Osteitis

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Keywords

  • Alveolar Osteitis
03

In context

Dry Socket

46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.

This study's enrollment of 98 is above the median of 60 across 41 interventional studies indexed under Dry Socket.

Browse Dry Socket studies →

Lead sponsor

Recep Tayyip Erdogan University is the lead sponsor of 69 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 ,
  8. Procedures that were not attended to control appointments (day 3-7) were not included.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
98 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugAbsorbable Gelatin

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

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

  • 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.

06

What researchers measure

Primary outcomes

  1. pain

    scored on visual analog scale from 0 to 10

    Time frame: 3.-7. days

  2. edema

    scored on visual analog scale from 0 to 10

    Time frame: 3. day - 7. day

  3. trismus

    marked yes or no based on clinical examination

    Time frame: 3. day - 7. day

  4. halitosis

    marked yes or no based on clinical examination

    Time frame: 3. day - 7. day

  5. alveolar osteitis

    marked yes or no based on clinical examination

    Time frame: 3. day - 7. day

  6. smoking habit

    marked yes or no based on anamnesis

    Time frame: operated day

  7. age

    marked yes or no based on anamnesis

    Time frame: operated day

  8. tooth type

    marked yes or no based on clinical examination

    Time frame: operated day

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06435832
Lead sponsor
Recep Tayyip Erdogan University
Responsible party
Zeynep Gumrukcu (Associate Professor, Recep Tayyip Erdogan University) — Principal investigator
First posted
May 30, 2024
Start date
May 16, 2024
Primary completion
May 26, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
May 30, 2024

Study contacts

Zeynep Gümrükçü
study director · Recep Tayyip Erdogan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Chlorhexidine · Tranexamic Acid

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