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Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction

Primary Purpose

Tooth Impaction, Tooth Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Surgery of impacted mandibular wisdom teeth
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tooth Impaction focused on measuring chlorhexidine, wisdom teeth, dental surgery

Eligibility Criteria

18 Years - 31 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Volunteers with bilateral fully impacted mandibular wisdom teeth Exclusion Criteria: Patients were excluded from the study if they did not understand the clinical procedures of the study, Had allergies or intolerance to any of the substances used in the study, Patients on anticoagulant or psychiatric treatment, Pregnant or breastfeeding, Patients using oral contraceptiveswere, Diabetic, Patients with periodontal disease or active infection Smokers of more than 10 cigarettes per day, Poor oral hygiene

Sites / Locations

  • Van Yuzuncu Yil University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group using chlorhexidine toothpaste after wisdom tooth extraction

Control group using chlorhexidine-free toothpaste after wisdom tooth extraction

Arm Description

22 patients, 17 females and 5 males, 44 bilateral, similarly positioned fully impacted impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the experimental group received Dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine

Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the control group was given toothpaste with the same ingredients as the study group but without chlorhexidine.

Outcomes

Primary Outcome Measures

Mouth opening measurements
the distance between the incisals of the patient's central teeth at maximal mouth opening.
Facial edema
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
Wound healing
View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.
Visual Analog Scale
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
Microbiological analysis
Prior to extraction, a saliva sample was collected from the patient and placed in a sterile 1.5 ml Eppendorf tube and then stored in a -40 oC freezer. After surgical extraction, the patient was given toothpaste with the same content but without chlorhexidine. After a 14-day recovery period, the saliva sample was collected again without extracting the impacted tooth on the contralateral side, and tooth extraction was performed. After the second extraction, the patient was given Dentasave 0.2% Chlorhex toothpaste. The third saliva sample was collected on day 28 (14 days after the second tooth extraction). Saliva samples were stored in sterile universal containers (Eppendorf tubes) and sent to the microbiology laboratory less than 3 hours after collection on days 0, 14, and 28 of the study.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2023
Last Updated
October 17, 2023
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT06067542
Brief Title
Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction
Official Title
Evaluation of the Clinical and Microbiological Effects of Chlorhexidine Toothpaste on Wound Healing Following Tooth Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the postoperative clinical and microbiologic effects of chlorhexidine toothpaste and chlorhexidine-free toothpaste with the same content were compared after bilateral mandibular impacted third molar surgery. Similarly positioned fully impacted impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the experimental group received Dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine and the control group received toothpaste with the same content but without chlorhexidine. Teeth were extracted by the same dentist at 14-day intervals. For microbiological analysis, saliva samples were taken before the first tooth extraction, before the second tooth extraction 14 days later and on the 28th day and sent to the microbiology laboratory. Wound healing, edema and trismus in both extractions were evaluated 1 week after tooth extraction. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment and recorded 14 days after tooth extraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Impaction, Tooth Diseases
Keywords
chlorhexidine, wisdom teeth, dental surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group using chlorhexidine toothpaste after wisdom tooth extraction
Arm Type
Experimental
Arm Description
22 patients, 17 females and 5 males, 44 bilateral, similarly positioned fully impacted impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the experimental group received Dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine
Arm Title
Control group using chlorhexidine-free toothpaste after wisdom tooth extraction
Arm Type
Placebo Comparator
Arm Description
Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the control group was given toothpaste with the same ingredients as the study group but without chlorhexidine.
Intervention Type
Procedure
Intervention Name(s)
Surgery of impacted mandibular wisdom teeth
Other Intervention Name(s)
Surgery of impacted mandibular wisdom teeth (the other side)
Intervention Description
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures.
Primary Outcome Measure Information:
Title
Mouth opening measurements
Description
the distance between the incisals of the patient's central teeth at maximal mouth opening.
Time Frame
0-28 days
Title
Facial edema
Description
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
Time Frame
0-28 days
Title
Wound healing
Description
View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.
Time Frame
0-28 days
Title
Visual Analog Scale
Description
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
Time Frame
0-28 days
Title
Microbiological analysis
Description
Prior to extraction, a saliva sample was collected from the patient and placed in a sterile 1.5 ml Eppendorf tube and then stored in a -40 oC freezer. After surgical extraction, the patient was given toothpaste with the same content but without chlorhexidine. After a 14-day recovery period, the saliva sample was collected again without extracting the impacted tooth on the contralateral side, and tooth extraction was performed. After the second extraction, the patient was given Dentasave 0.2% Chlorhex toothpaste. The third saliva sample was collected on day 28 (14 days after the second tooth extraction). Saliva samples were stored in sterile universal containers (Eppendorf tubes) and sent to the microbiology laboratory less than 3 hours after collection on days 0, 14, and 28 of the study.
Time Frame
0-28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteers with bilateral fully impacted mandibular wisdom teeth Exclusion Criteria: Patients were excluded from the study if they did not understand the clinical procedures of the study, Had allergies or intolerance to any of the substances used in the study, Patients on anticoagulant or psychiatric treatment, Pregnant or breastfeeding, Patients using oral contraceptiveswere, Diabetic, Patients with periodontal disease or active infection Smokers of more than 10 cigarettes per day, Poor oral hygiene
Facility Information:
Facility Name
Van Yuzuncu Yil University
City
Van
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction

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