- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364253
'Propolis Versus Chlorhexidine Gluconate on Wound Healing After Third Molar Surgery: a Randomized Controlled Trial'
Clinical Evaluation Of The Effects Of Propolis Gargle On Wound Healing After Impacted Third Molar Surgery
The goal of this study is to examine the effects of propolis gargle on wound healing following third molar surgery and to compare it with chlorhexidine gluconate. The main question it aims to answer is:
Is propolis-containing gargle safe and effective alternative to chlorhexidine gluconate following impacted third molar surgery? Does propolis demonstrate comparable outcomes in pain control and mouth opening ?
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yakutiye
-
Erzurum, Yakutiye, Turkey (Türkiye), 25240
- Atatürk University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of the impacted teeth were classified as Class II level B mesioangular position
- Patients from a socioeconomic level who can actively use postoperative gargles
Exclusion Criteria:
- Individuals with third molars exhibiting acute infection
- smokers
- pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Propolis gargle
Patients were randomly allocated into two groups: one group used 0.12% chlorhexidine gluconate gargle, while the other used a 3% propolis-containing gargle.
Gargles were applied twice daily for one minute from postoperative day 2 to day 7. Pain was evaluated using the visual analog scale (VAS), while edema, maximum mouth opening, wound healing, and postoperative complications were assessed preoperatively and on postoperative days 2 and 7.
|
The patients were anesthetized with inferior alveolar, lingual, and buccal nerve blocks using 4 ml of articaine with 1:100,000 epinephrine (Ultracaine D-S Fort, Aventis).
The tooth could be observed by elevating a full-thickness triangular mucoperiosteal flap.
The tooth was extracted following an osteotomy using a bur.
The tooth was sectioned and extracted, if required.
Curettage was conducted in the presence of a residual dental follicle.
The wound was sutured with silk thread.
All procedures were conducted by the same physician.
Postoperatively, antibiotics (amoxicillin combined with clavulanic acid, 2 g daily for 5 days) and analgesics (paracetamol 1 g, up to 4 times daily for 3 days) were recommended.
The group was administered a 3% propolis gargle (formulated in an ethanol solution, twice daily for 1 minute, prepared in the Departments of Pharmacology.
|
|
Active Comparator: Chlorhexidine Gluconate gargle
Patients were randomly allocated into two groups: one group used 0.12% chlorhexidine gluconate gargle, while the other used a 3% propolis-containing gargle.
Gargles were applied twice daily for one minute from postoperative day 2 to day 7. Pain was evaluated using the visual analog scale (VAS), while edema, maximum mouth opening, wound healing, and postoperative complications were assessed preoperatively and on postoperative days 2 and 7.
|
The patients were anesthetized with inferior alveolar, lingual, and buccal nerve blocks using 4 ml of articaine with 1:100,000 epinephrine (Ultracaine D-S Fort, Aventis).
The tooth could be observed by elevating a full-thickness triangular mucoperiosteal flap.
The tooth was extracted following an osteotomy using a bur.
The tooth was sectioned and extracted, if required.
Curettage was conducted in the presence of a residual dental follicle.
The wound was sutured with silk thread.
All procedures were conducted by the same physician.
Postoperatively, antibiotics (amoxicillin combined with clavulanic acid, 2 g daily for 5 days) and analgesics (paracetamol 1 g, up to 4 times daily for 3 days) were recommended.
The group was administered chlorhexidine gluconate (0.12%) gargle, twice daily for 1 minute.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edema
Time Frame: Before surgery to after surgery seventh day
|
Edema (assessed by measuring the distances between the tragus and lip corner, as well as the outer corner of the eye and mandibular corner, with measurements taken twice using a paper ruler and averaged), It was measured before surgery, after surgery second and seventh days.
|
Before surgery to after surgery seventh day
|
|
Pain after surgery
Time Frame: After surgery, post- op second and seventh day
|
Patient records were collected on the second and seventh days post-operation.
The evaluated parameters included pain (measured using the VAS scale).
Visual analog scale is used to measure pain intensity.
It consists of a straight line usually 10 cm.
0: no pain, 10: worst pain imaginable.
The patient marks the point that best represents their pain.
|
After surgery, post- op second and seventh day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum mouth opening
Time Frame: Before surgery to post surgery seventh day
|
Maximum mouth opening (the distance between the lower and upper incisors) were measured before surgery and after surgery second and seventh day.
|
Before surgery to post surgery seventh day
|
|
Wound aperture
Time Frame: From surgery to seventh day after surgery
|
Wound aperture after surgery was examined for two groups
|
From surgery to seventh day after surgery
|
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
- 2020/3-4
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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