## Protocol Section
### Identification Module
**NCT ID:** NCT06435832

**Brief Title:** Evaluations of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence

**Official Title:** Evaluation of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence

#### Organization Study ID Info
**ID:** RTEUni
#### Organization
**Class:** OTHER
**Full Name:** Recep Tayyip Erdogan University
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-26

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Recep Tayyip Erdogan University

#### Responsible Party

**Investigator Affiliation:** Recep Tayyip Erdogan University

**Investigator Full Name:** Zeynep Gumrukcu

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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 Module

**Conditions:**

- Alveolar Osteitis

**Keywords:**

- Alveolar Osteitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 98

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Absorbable Gelatin

**Label:** just absorbable gelatin

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Drug: Chlorhexidine

**Label:** absorbable gelatin with Chlorhexidine gel

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** 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 Names:**

- Drug: Tranexamic acid

**Label:** absorbable gelatin with tranexamic acid

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- just absorbable gelatin

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

**Name:** Absorbable Gelatin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- absorbable gelatin with Chlorhexidine gel

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

**Name:** Chlorhexidine

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- absorbable gelatin with tranexamic acid

**Description:** 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.

**Name:** Tranexamic acid

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** scored on visual analog scale from 0 to 10

**Measure:** pain

**Time Frame:** 3.-7. days

**Description:** scored on visual analog scale from 0 to 10

**Measure:** edema

**Time Frame:** 3. day - 7. day

**Description:** marked yes or no based on clinical examination

**Measure:** trismus

**Time Frame:** 3. day - 7. day

**Description:** marked yes or no based on clinical examination

**Measure:** halitosis

**Time Frame:** 3. day - 7. day

**Description:** marked yes or no based on clinical examination

**Measure:** alveolar osteitis

**Time Frame:** 3. day - 7. day

**Description:** marked yes or no based on anamnesis

**Measure:** smoking habit

**Time Frame:** operated day

**Description:** marked yes or no based on anamnesis

**Measure:** age

**Time Frame:** operated day

**Description:** marked yes or no based on clinical examination

**Measure:** tooth type

**Time Frame:** operated day

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rize

**Country:** Turkey

**Facility:** Recep Tayyip Erdoğan University

**Zip:** 53020

#### Overall Officials

**Official 1:**

**Affiliation:** Recep Tayyip Erdogan University

**Name:** Zeynep Gümrükçü

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M12923

- Name: Osteitis

- Relevance: HIGH

- As Found: Osteitis

- ID: M7542

- Name: Dry Socket

- Relevance: HIGH

- As Found: Alveolar Osteitis

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010000

- Term: Osteitis

- ID: D000004368

- Term: Dry Socket

### Intervention Browse Module - Ancestors

- ID: D000000933

- Term: Antifibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000006490

- Term: Hemostatics

- ID: D000003029

- Term: Coagulants

- ID: D000000891

- Term: Anti-Infective Agents, Local

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000004202

- Term: Disinfectants

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M5953

- Name: Chlorhexidine

- Relevance: HIGH

- As Found: Needs

- ID: M16902

- Name: Tranexamic Acid

- Relevance: HIGH

- As Found: Stage IV

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M344731

- Name: Chlorhexidine gluconate

- Relevance: LOW

- As Found: Unknown

- ID: M8896

- Name: Gelatin Sponge, Absorbable

- Relevance: LOW

- As Found: Unknown

- ID: M4252

- Name: Antifibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M6259

- Name: Coagulants

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4215

- Name: Anti-Infective Agents, Local

- Relevance: LOW

- As Found: Unknown

- ID: M7383

- Name: Disinfectants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002710

- Term: Chlorhexidine

- ID: D000014148

- Term: Tranexamic Acid

### Misc Info Module

- Version Holder: 2024-05-31
