Alveolar OsteitisNCT06435832
Evaluations of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence
A study testing Absorbable Gelatin, Chlorhexidine and Tranexamic acid in people with Alveolar Osteitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Absorbable Gelatin, Chlorhexidine and Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals between the ages of 18-65
- Molar and premolar teeth with extraction indication
Who cannot join
- 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),
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- Women are lactating or pregnant,
- Using oral contraceptives,
- Procedures that were not attended to control appointments (day 3-7) were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alveolar Osteitis
- Being tested
- Absorbable Gelatin, Chlorhexidine, Tranexamic acid
- Keywords
- Alveolar Osteitis
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable GelatinDrug
After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.
ChlorhexidineDrug
After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.
Tranexamic acidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| just absorbable gelatin | Active comparator | After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket. Receives: 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. Receives: 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. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
scored on visual analog scale from 0 to 10
Measured: 3.-7. days
edema
scored on visual analog scale from 0 to 10
Measured: 3. day - 7. day
trismus
marked yes or no based on clinical examination
Measured: 3. day - 7. day
halitosis
marked yes or no based on clinical examination
Measured: 3. day - 7. day
alveolar osteitis
marked yes or no based on clinical examination
Measured: 3. day - 7. day
smoking habit
marked yes or no based on anamnesis
Measured: operated day
age
marked yes or no based on anamnesis
Measured: operated day
tooth type
marked yes or no based on clinical examination
Measured: operated day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start16 May 2024
- Primary completion26 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar OsteitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Gumrukcu, Recep Tayyip Erdogan University
- Investigators
- Zeynep Gümrükçü, Study director, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435832
- Sponsor's protocol ID
- RTEUni
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39167305
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence
- ClinicalTrials.gov ID
- NCT06435832
- Acronym / sponsor ID
- RTEUni
- Conditions
- Alveolar Osteitis
- Keywords
- Alveolar Osteitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 26 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| just absorbable gelatin | Active comparator | Drug: Absorbable GelatinAfter tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket. |
| absorbable gelatin with Chlorhexidine gel | Active comparator | Drug: ChlorhexidineAfter tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket. |
| absorbable gelatin with tranexamic acid | Active comparator | Drug: Tranexamic acidTranexamic acid 50mg/ml for injection after saline irrigation after tooth extraction solution into gelatin sponges was applied to the socket after it was cured. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy individuals between the ages of 18-65
- Molar and premolar teeth with extraction indication
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable GelatinAfter tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket. | Drug | just absorbable gelatin |
| ChlorhexidineAfter tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket. | Drug | absorbable gelatin with Chlorhexidine gel |
| Tranexamic acidTranexamic 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 | absorbable gelatin with tranexamic acid |
Primary outcome
pain
Time frame: 3.-7. days
scored on visual analog scale from 0 to 10
edema
Time frame: 3. day - 7. day
scored on visual analog scale from 0 to 10
trismus
Time frame: 3. day - 7. day
marked yes or no based on clinical examination
halitosis
Time frame: 3. day - 7. day
marked yes or no based on clinical examination
alveolar osteitis
Time frame: 3. day - 7. day
marked yes or no based on clinical examination
smoking habit
Time frame: operated day
marked yes or no based on anamnesis
age
Time frame: operated day
marked yes or no based on anamnesis
tooth type
Time frame: operated day
marked yes or no based on clinical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 39167305Gumrukcu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Gümrükçü study director
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable Gelatin, Chlorhexidine and Tranexamic acid in people with Alveolar Osteitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 3.-7. days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.