Impacted Mandibular Third Molar
Conditions
Keywords
wisdom tooth surgery, postoperative morbidity, chlorhexidine, benzydamine, flurbiprofen, split-mouth study
Brief summary
This study aims to compare the effects of two commonly used topical mouth sprays on pain, swelling, and limitation of mouth opening after surgical removal of impacted lower wisdom teeth. A total of 40 adult patients who require the removal of both lower impacted wisdom teeth will participate in this study. Each patient will undergo two separate surgical procedures, with a healing period between them. After each surgery, one of the two topical agents will be applied to the surgical area. The order of the treatments will be randomly assigned. The study is designed so that neither the patients nor the clinician evaluating the outcomes will know which topical agent is used at each session. Pain levels, facial swelling, and mouth opening will be measured at specific time points after surgery. The results will help determine whether one topical treatment is more effective than the other in reducing postoperative discomfort and improving recovery. The information obtained from this study may contribute to improving postoperative care following wisdom tooth surgery.
Interventions
DRUGKloroben topical spray
Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus.
DRUGKlorhex Plus topical spray
Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Monitor Clinician
Intervention model description
This is a randomized, double-blind, crossover (split-mouth) clinical trial. Each participant undergoes two separate surgical procedures for bilateral impacted mandibular third molar extraction. After each procedure, a different topical agent is applied in a randomized order, with a healing period between interventions. Outcomes are compared within the same participant to minimize inter-individual variability.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged between 18 and 50 years * Indication for bilateral impacted mandibular third molar extraction * ASA physical status I or II * No antibiotic use within the previous two weeks * No analgesic use within the previous 12 hours * Ability to provide written informed consent
Exclusion criteria
* ASA physical status III to V * Pregnancy or breastfeeding * Known allergy to chlorhexidine, benzydamine, or flurbiprofen * Smoking more than one pack per day * History of substance abuse * Presence of systemic diseases that may affect wound healing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity assessed by Visual Analog Scale (VAS) | From 30 minutes to 168 hours after surgery | Postoperative pain intensity assessed by the Visual Analog Scale (VAS, 0-10 cm), where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate greater pain intensity. |
| Postoperative facial swelling measurements | Preoperatively, postoperative day 2 and postoperative day 7 | Postoperative facial swelling measured by linear facial distances (in centimeters) including tragus to pogonion, tragus to labial commissure, and mandibular angle to lateral canthus; higher values indicate greater swelling. |
| Maximum mouth opening (trismus assessment) | Preoperatively, postoperative day 2 and postoperative day 7 | Trismus will be evaluated by measuring the maximum interincisal distance between the upper and lower central incisors using a ruler. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesic consumption | From the day of surgery to postoperative day 7 | The number of analgesic tablets consumed by each patient will be recorded daily following surgery. |
Countries
Turkey (Türkiye)
Outcome results
None listed