Clinical trial NCT05466604: Comparison of Hyaluronidase and Dexametasone in Reduction of Postoperative Edema
Official title: Comparison of the Effects of Hyaluronidase and Dexamethasone on Reduction of Postoperative Edema in Impacted Wisdom Teeth Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Edema
Pain
Trismus
Infection, Surgical Site
Keywords: postoperative edema
wisdom teeth
trismus
pain control
wound infection
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is designed to reveal effectiveness of hyaluronidase and dexamethasone on reduction of postoperative edema, pain, trismus, and infection. For this purpose, 60 participants with symmetrical mandibular wisdom teeth enrolled the present study. All measurements and evaluations were performed before and 1, 2, 3, and 7 days later the operation.


Eligibility criteria: Inclusion Criteria:

* symmetrical mandibular wisdom teeth with bone retention
* patients who are signed informed consent and acceptance of study involvement forms

Exclusion Criteria:

* existence of any systemic disease
* existence of any periodical drug intake
* existence of difference in operation times of right and left impacted wisdom teeth extractions more than 5 minutes
* existence of pregnancy
* existence of breastfeeding

Primary outcomes:
measure: evaluation of the increase of edema in postoperative 1. day using a measuring tape in hyaluronidase experimental group
timeFrame: postoperative 1. day
measure: evaluation of the increase of edema in postoperative 2. day using a measuring tape in hyaluronidase experimental group
timeFrame: postoperative 2. day
measure: evaluation of the increase of edema in postoperative 3. day using a measuring tape in hyaluronidase experimental group
timeFrame: postoperative 3. day
measure: evaluation of the increase of edema in postoperative 7. day using a measuring tape in hyaluronidase experimental group
timeFrame: postoperative 7. day
measure: evaluation of the increase of edema in postoperative 1. day using a measuring tape in hyaluronidase control group
timeFrame: postoperative 1. day
measure: evaluation of the increase of edema in postoperative 2. day using a measuring tape in hyaluronidase control group
timeFrame: postoperative 2. day
measure: evaluation of the increase of edema in postoperative 3. day using a measuring tape in hyaluronidase control group
timeFrame: postoperative 3. day
measure: evaluation of the increase of edema in postoperative 7. day using a measuring tape in hyaluronidase control group
timeFrame: postoperative 7. day
measure: evaluation of the increase of edema in postoperative 1. day using a measuring tape in dexamethasone experimental group
timeFrame: postoperative 1. day
measure: evaluation of the increase of edema in postoperative 2. day using a measuring tape in dexamethasone experimental group
timeFrame: postoperative 2. day
measure: evaluation of the increase of edema in postoperative 3. day using a measuring tape in dexamethasone experimental group
timeFrame: postoperative 3. day
measure: evaluation of the increase of edema in postoperative 7. day using a measuring tape in dexamethasone experimental group
timeFrame: postoperative 7. day
measure: evaluation of the increase of edema in postoperative 1. day using a measuring tape in dexamethasone control group
timeFrame: postoperative 1. day
measure: evaluation of the increase of edema in postoperative 2. day using a measuring tape in dexamethasone control group
timeFrame: postoperative 2. day
measure: evaluation of the increase of edema in postoperative 3. day using a measuring tape in dexamethasone control group
timeFrame: postoperative 3. day
measure: evaluation of the increase of edema in postoperative 7. day using a measuring tape in dexamethasone control group
timeFrame: postoperative 7. day
measure: evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 1. day using a measuring tape
timeFrame: postoperative 1. day
measure: evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 2. day using a measuring tape
timeFrame: postoperative 2. day
measure: evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 3. day using a measuring tape
timeFrame: postoperative 3. day
measure: evaluation of the difference in increase amounts of edema between hyaluronidase experimental and hyaluronidase control groups in postoperative 7. day using a measuring tape
timeFrame: postoperative 7. day
measure: evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 1. day using a measuring tape
timeFrame: postoperative 1. day
measure: evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 2. day using a measuring tape
timeFrame: postoperative 2. day
measure: evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 3. day using a measuring tape
timeFrame: postoperative 3. day
measure: evaluation of the difference in increase amounts of edema between dexamethasone experimental and dexamethasone control groups in postoperative 7. day using a measuring tape
timeFrame: postoperative 7. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 1. day
timeFrame: postoperative 1. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 2. day
timeFrame: postoperative 2. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 3. day
timeFrame: postoperative 3. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 4. day
timeFrame: postoperative 4. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 5. day
timeFrame: postoperative 5. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 6. day
timeFrame: postoperative 6. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase experimental group in postoperative 7. day
timeFrame: postoperative 7. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 1. day
timeFrame: postoperative 1. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 2. day
timeFrame: postoperative 2. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 3. day
timeFrame: postoperative 3. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 4. day
timeFrame: postoperative 4. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 5. day
timeFrame: postoperative 5. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 6. day
timeFrame: postoperative 6. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in hyaluronidase control group in postoperative 7. day
timeFrame: postoperative 7. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 1. day
timeFrame: postoperative 1. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 2. day
timeFrame: postoperative 2. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 3. day
timeFrame: postoperative 3. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 4. day
timeFrame: postoperative 4. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 5. day
timeFrame: postoperative 5. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 6. day
timeFrame: postoperative 6. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone experimental group in postoperative 7. day
timeFrame: postoperative 7. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 1. day
timeFrame: postoperative 1. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 2. day
timeFrame: postoperative 2. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 3. day
timeFrame: postoperative 3. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 4. day
timeFrame: postoperative 4. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 5. day
timeFrame: postoperative 5. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 6. day
timeFrame: postoperative 6. day
measure: evaluation of the pain using visual analog scale (VAS) and daily count of NSAİ drug intake in dexamethasone control group in postoperative 7. day
timeFrame: postoperative 7. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group preoperatively.
timeFrame: preoperative
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 1. day.
timeFrame: postoperative 1. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 2. day.
timeFrame: postoperative 2. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 3. day.
timeFrame: postoperative 3. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase experimental group in postoperative 7. day.
timeFrame: postoperative 7. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group preoperatively.
timeFrame: preoperative
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 1. day.
timeFrame: postoperative 1. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 2. day.
timeFrame: postoperative 2. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 3. day.
timeFrame: postoperative 3. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of hyaluronidase control group in postoperative 7. day.
timeFrame: postoperative 7. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group preoperatively.
timeFrame: preoperative
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 1. day.
timeFrame: postoperative 1. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 2. day.
timeFrame: postoperative 2. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 3. day.
timeFrame: postoperative 3. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone experimental group in postoperative 7. day.
timeFrame: postoperative 7. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group preoperatively.
timeFrame: preoperative
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 1. day.
timeFrame: postoperative 1. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 2. day.
timeFrame: postoperative 2. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 3. day.
timeFrame: postoperative 3. day
measure: evaluation of trismus using a ruler, which measures the opening between mandibular and maxillary right first incisors of dexamethasone control group in postoperative 7. day.
timeFrame: postoperative 7. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group preoperatively.
timeFrame: preoperative
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 1. day.
timeFrame: postoperative 1. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 2. day.
timeFrame: postoperative 2. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 3. day.
timeFrame: postoperative 3. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase experimental group in postoperative 7. day.
timeFrame: postoperative 7. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group preoperatively.
timeFrame: preoperative
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 1. day.
timeFrame: postoperative 1. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 2. day.
timeFrame: postoperative 2. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 3. day.
timeFrame: postoperative 3. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of hyaluronidase control group in postoperative 7. day.
timeFrame: postoperative 7. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group preoperatively.
timeFrame: preoperative
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 1. day
timeFrame: postoperative 1. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 2. day
timeFrame: postoperative 2. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 3. day
timeFrame: postoperative 3. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone experimental group in postoperative 7. day
timeFrame: postoperative 7. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group preoperatively.
timeFrame: preoperatively
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 1. day
timeFrame: postoperative 1. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 2. day
timeFrame: postoperative 2. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 3. day
timeFrame: postoperative 3. day
measure: evaluation of infection in operation site via determination of infection signs in physical examination of dexamethasone control group in postoperative 7. day
timeFrame: postoperative 7. day
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Near East University
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
References: