Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05765240 |
| Other study ID # |
2015-KAEK-43-19-25 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
February 27, 2023 |
| Est. completion date |
November 1, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Atlas University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Tooth extraction is one of the major surgical procedures that can cause dental anxiety and
dental fear in pediatric patients as a result of traumatic experiences. Preventing pain and
infection by appropriate means during and after this application increases patient comfort
and helps to develop patient cooperation for possible future dental experiences.
In the current literature, it has been shown that topical hyaluronic acid applications have a
role in reducing infection and pain.
There are also studies in the literature showing that tissue biostimulation with different
doses of diode laser application accelerates wound healing by promoting cell regeneration.
Although there are studies showing that two different applications accelerate wound healing,
there is no study comparing the effectiveness of these two methods. In addition, there is no
study evaluating extraction wound healing in pediatric patients.
Our study will be the first to evaluate tooth extraction wound healing in pediatric patients
and to compare these two methods.
Description:
Sample Size:
Our study will include 60 children aged between 5-13 years who are systemically healthy and
volunteer to participate in the study, with indications for extraction of primary or
permanent molars for various reasons.
In the study, the GPOWER 3.1 package program was used to determine the sufficient sample
volume.
Steps followed when calculating sample volume;
1st type margin of error (α) = 0.05 The mean (1.72) and standard deviation (1.14) values of
the 7th day VAS scores of the participants in the "control" group were taken into account.
The mean (0.92) and standard deviation (0.81) values of the 7th day VAS scores of the
participants in the "Hyaluronic Acid (HA)" group were taken into account.
Using the relevant mean and standard deviation values, the effect size was calculated as
0.9876543.
The power of the test was taken as (1-β) = 0.80. As a result of the calculations, the sample
volume that will provide the power of the test (1-β) = 0.80 was determined as 54 people in
total, with a minimum of 18 in each group.
Considering the possible reductions in the follow-up process, the sample number was
determined as 60 people, 20 people in each group.
Study Design:
Children with primary or permanent molar extraction indications will be divided into three
as:
Group 1: Hyaluronic Acid Gel Group Group 2: Diode Laser Group The control group.
As a result of clinical and radiographic examination, the extraction of primary or permanent
molar teeth will be performed by a single investigator under local anesthesia.
All patient groups will be evaluated by a single investigator at the time of the extraction
and on the 7th, 14th, and 21st days following the extraction. The same investigator will
perform an intraoral examination before extraction and record the caries status using DMFT
and dft scoring.
Pain assessment will be made through the Wong-Baker Faces Pain Scale suitable for ages 3-18.
The patient will be asked to score the pain felt at the extraction site during the period
between follow-up appointments, and a total of 3 assessments will be made.
In all groups, the presence of edema and infection will be evaluated by a single investigator
on the 7th, 14th, and 21st days following the extraction.
Wound dimensions (dehiscent, mesiodistal and buccolingual longest distances on the socket)
will be determined by a single investigator immediately after the extraction and on the 3rd,
7th, and 14th days following the extraction, and recorded with photographs taken from a
standard distance.
In the control group, the wound area will be followed without any application after tooth
extraction.
Hyaluronic acid gel will be applied to the extraction site of the patients in the hyaluronic
acid gel group immediately after the extraction.
In the diode laser group, the alveolar socket will be irradiated with a potency of 20mW/670
nm and an energy dose of 4 J/cm2 for 7 minutes immediately after extraction.
