- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06067542
Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction
Evaluation of the Clinical and Microbiological Effects of Chlorhexidine Toothpaste on Wound Healing Following Tooth Extraction
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Van, Turkey, 65080
- Van Yuzuncu Yil University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group using chlorhexidine toothpaste after wisdom tooth extraction
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
|
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.
Other Names:
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Placebo Comparator: Control group using chlorhexidine-free toothpaste after wisdom tooth extraction
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mouth opening measurements
Time Frame: 0-28 days
|
the distance between the incisals of the patient's central teeth at maximal mouth opening.
|
0-28 days
|
Facial edema
Time Frame: 0-28 days
|
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.
|
0-28 days
|
Wound healing
Time Frame: 0-28 days
|
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.
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0-28 days
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Visual Analog Scale
Time Frame: 0-28 days
|
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.
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0-28 days
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Microbiological analysis
Time Frame: 0-28 days
|
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. |
0-28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YYU-04/04.03.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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