Kwoen, Min-Jeong
(Department of Oral and Periodontology, Section of Dentistry, Seoul National University Bundang Hospital)
,
Choi, Yong-Hoon
(Department of Conservative Dentistry, Section of Dentistry, Seoul National University Bundang Hospital)
,
Kim, Keun-Suh
(Department of Oral and Periodontology, Section of Dentistry, Seoul National University Bundang Hospital)
,
Chang, Na-Hee
(Biomedical Research Institute, Seoul National University Bundang Hospital)
,
Kim, Young-Kyun
(Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital)
,
Lee, Hyo-Jung
(Department of Oral and Periodontology, Section of Dentistry, Seoul National University Bundang Hospital)
Objectives: Hyaluronoglucosaminidase (hyaluronidase) increases the local intercellular permeability of the peripheral lymphatic channel and capillaries, which may help reduce edema. In the present study, the effects of hyaluronidase on postoperative edema and pain reduction were evaluated. Materials...
Objectives: Hyaluronoglucosaminidase (hyaluronidase) increases the local intercellular permeability of the peripheral lymphatic channel and capillaries, which may help reduce edema. In the present study, the effects of hyaluronidase on postoperative edema and pain reduction were evaluated. Materials and Methods: The study included 38 patients who underwent guided bone regeneration (GBR) surgery before implantation. Patients were randomly assigned to either the control group (n=20) or the test group (n=18). Hyaluronidase was injected into the GBR site of subjects in the test group. Postoperative edema was evaluated by measuring the distance between specific facial landmarks immediately after surgery (T1) and 2-4 days after surgery (T2). The degree of pain at T2 and at 10-14 days after surgery (T3) was assessed. Results: In the test group, the degree of swelling was lower than in the control group, however, only two measurements, from the tragus to the mouth corner and from the outer canthus to the mouth corner, showed statistically significant differences (P=0.012 and P=0.001, respectively). The anti-edema effect of hyaluronidase was more effective in the maxilla than in the mandible. In the maxilla, the percentage of facial swelling was significant for three measurements. However, in the mandible, the percentage of facial swelling was significant for only one measurement. Low levels of pain that were similar at T2 and T3 were reported in both groups. Conclusion: The results indicate the degree of swelling was lower in the test group and hyaluronidase appeared to be more effective in the maxilla. The degree of pain reduction was similar between groups. Further in vivo and randomized controlled trials with larger sample sizes are warranted.
Objectives: Hyaluronoglucosaminidase (hyaluronidase) increases the local intercellular permeability of the peripheral lymphatic channel and capillaries, which may help reduce edema. In the present study, the effects of hyaluronidase on postoperative edema and pain reduction were evaluated. Materials and Methods: The study included 38 patients who underwent guided bone regeneration (GBR) surgery before implantation. Patients were randomly assigned to either the control group (n=20) or the test group (n=18). Hyaluronidase was injected into the GBR site of subjects in the test group. Postoperative edema was evaluated by measuring the distance between specific facial landmarks immediately after surgery (T1) and 2-4 days after surgery (T2). The degree of pain at T2 and at 10-14 days after surgery (T3) was assessed. Results: In the test group, the degree of swelling was lower than in the control group, however, only two measurements, from the tragus to the mouth corner and from the outer canthus to the mouth corner, showed statistically significant differences (P=0.012 and P=0.001, respectively). The anti-edema effect of hyaluronidase was more effective in the maxilla than in the mandible. In the maxilla, the percentage of facial swelling was significant for three measurements. However, in the mandible, the percentage of facial swelling was significant for only one measurement. Low levels of pain that were similar at T2 and T3 were reported in both groups. Conclusion: The results indicate the degree of swelling was lower in the test group and hyaluronidase appeared to be more effective in the maxilla. The degree of pain reduction was similar between groups. Further in vivo and randomized controlled trials with larger sample sizes are warranted.
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제안 방법
All adverse events that occurred during the clinical trial were included in the safety assessment, recorded in the case report, and their abnormality evaluated. Treatment-emergent adverse events were recorded up to 14 weeks from the time of application of the clinical trial drug.
In this prospective study, the effect of the topical application of hyaluronidase during GBR surgery on postoperative edema and pain was evaluated. Although each step in the study was conducted according to the relevant guidelines, standardization of the location and size of the surgical site was not possible.
used was recorded. Registered subjects were numbered sequentially, starting from R01, and patients were assigned to the test group and control group. The randomization code was generated by a statistician using a block randomization method and a computer program; the contents were enclosed in an envelope and transmitted to the person in charge.
대상 데이터
55 years. Among the 18 participants in the test group, 11 were male and 7 were female, with a mean age of 57.7 years.(Table 1)
At the beginning of the trial, we aimed to evaluate 20 patients in each group. The sample size was calculated based on health medicine statistics.
Eleven of the 18 patients in the test group underwent surgery of the maxilla and the remaining 7 underwent surgery of the mandible. The 38 patients who agreed to participate in the study were between 31 and 79 years of age (mean age, 59.2 years). Among the 20 controls, 15 were male and 5 were fe- male.
데이터처리
The Shapiro– Wilk test was used to evaluate the data distribution. Because the data followed a non-normal distribution, differences between groups were assessed using the nonparametric Mann– Whitney U test. Statistical analyses were performed using IBM SPSS Statistics (ver.
2010 (Microsoft, Redmond, WA, USA). The Shapiro– Wilk test was used to evaluate the data distribution. Because the data followed a non-normal distribution, differences between groups were assessed using the nonparametric Mann– Whitney U test.
이론/모형
The degree of pain at T2 and the degree of pain at 10-14 days after surgery (T3) were assessed using the numerical rating scale (NRS). The extent of pain reduction was evaluated by calculating the difference between T2 and T3.
후속연구
The ability of a local injection of hyaluronidase to reduce edema in the dental field has been assessed in only a few studies. Therefore, further in vivo studies with larger sample size and randomized controlled trials are needed to validate our results.
참고문헌 (22)
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