Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2025-12-17 @ 1:11 AM
Study NCT ID:
NCT04889781
Status:
None
Last Update Posted:
2021-05-17 00:00:00
First Post:
2021-05-09 00:00:00
Brief Title:
Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery
Sponsor:
Central Military Healthcare - Oral and Maxillofacial Surgery Department
Organization:
Central Military Healthcare - Oral and Maxillofacial Surgery Department
Study Overview
Official Title:
Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery: A Randomized Clinical Trial
Status:
None
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Third molar surgery is the most common procedure performed in oral and maxillofacial surgery practice.
This procedure is always associated with varying degrees of postoperative pain and swelling that may have a social impact. Traditionally, rotating instruments like burs have been used for osseous surgery.
Piezosurgery is a novel technique introduced to overcome the disadvantages associated with the conventional rotatory technique. Corticosteroids administration before or after the extraction of third molars is an efficient way to minimize postoperative pain due to their strong anti-inflammatory activity.
Many researchers conducted studies comparing the piezosurgery technique with conventional rotatory technique, regarding postoperative pain and working time, or studies comparing the conventional method with or without dexamethasone injection. Only one recent study (Nov 2018), conducted by Gümrükçü Z. et al. has compared Piezosurgery and dexamethasone injection in third molar surgery, but without evaluating the combined effect of these two techniques on postoperative pain.
Objectives: The objective of this study is to assess the effects of piezosurgery technique and intramuscular dexamethasone injection on postoperative pain in impacted third molar surgery.
Methods: The study design is a randomized controlled clinical trial: 80 patients with mandibular third molar impaction, indicated for surgical extraction should be treated randomly using either the piezosurgery or the conventional rotatory technique, and with or without intramuscular dexamethasone injection. Postoperative pain will be assessed using a visual analog scale (VAS) on days 1, 3, and seven postoperatively.
The differences in Post-operative pain within and between study groups (4 groups) will be tested using repeated measures of analysis of variance (ANOVA) or Friedman tests. Differences in working time among the three techniques will be assessed using a repeated measure of ANOVA. All statistical tests will be two-sided, and the significant level will be set at 0.05. All the analysis will be conducted using the Statistical Package for Social Sciences (SPSS) software version 22.
This procedure is always associated with varying degrees of postoperative pain and swelling that may have a social impact. Traditionally, rotating instruments like burs have been used for osseous surgery.
Piezosurgery is a novel technique introduced to overcome the disadvantages associated with the conventional rotatory technique. Corticosteroids administration before or after the extraction of third molars is an efficient way to minimize postoperative pain due to their strong anti-inflammatory activity.
Many researchers conducted studies comparing the piezosurgery technique with conventional rotatory technique, regarding postoperative pain and working time, or studies comparing the conventional method with or without dexamethasone injection. Only one recent study (Nov 2018), conducted by Gümrükçü Z. et al. has compared Piezosurgery and dexamethasone injection in third molar surgery, but without evaluating the combined effect of these two techniques on postoperative pain.
Objectives: The objective of this study is to assess the effects of piezosurgery technique and intramuscular dexamethasone injection on postoperative pain in impacted third molar surgery.
Methods: The study design is a randomized controlled clinical trial: 80 patients with mandibular third molar impaction, indicated for surgical extraction should be treated randomly using either the piezosurgery or the conventional rotatory technique, and with or without intramuscular dexamethasone injection. Postoperative pain will be assessed using a visual analog scale (VAS) on days 1, 3, and seven postoperatively.
The differences in Post-operative pain within and between study groups (4 groups) will be tested using repeated measures of analysis of variance (ANOVA) or Friedman tests. Differences in working time among the three techniques will be assessed using a repeated measure of ANOVA. All statistical tests will be two-sided, and the significant level will be set at 0.05. All the analysis will be conducted using the Statistical Package for Social Sciences (SPSS) software version 22.
Detailed Description:
Background Third molar surgery is the most common procedure performed in oral and maxillofacial surgery practice
This procedure is always associated with varying degrees of postoperative pain and swelling that may have a social impact Traditionally rotating instruments like burs have been used for osseous surgery
Piezosurgery is a novel technique introduced to overcome the disadvantages associated with the conventional rotatory technique Corticosteroids administration before or after the extraction of third molars is an efficient way to minimize postoperative pain due to their strong anti-inflammatory activity
Many researchers conducted studies comparing the piezosurgery technique with conventional rotatory technique regarding postoperative pain and working time or studies comparing the conventional method with or without dexamethasone injection Only one recent study Nov 2018 conducted by Gümrükçü Z et al has compared Piezosurgery and dexamethasone injection in third molar surgery but without evaluating the combined effect of these two techniques on postoperative pain
Objectives The objective of this study is to assess the effects of piezosurgery technique and intramuscular dexamethasone injection on postoperative pain in impacted third molar surgery
Methods The study design is a randomized controlled clinical trial 80 patients with mandibular third molar impaction indicated for surgical extraction should be treated randomly using either the piezosurgery or the conventional rotatory technique and with or without intramuscular dexamethasone injection Postoperative pain will be assessed using a visual analog scale VAS on days 1 3 and seven postoperatively
The differences in Post-operative pain within and between study groups 4 groups will be tested using repeated measures of analysis of variance ANOVA or Friedman tests Differences in working time among the three techniques will be assessed using a repeated measure of ANOVA All statistical tests will be two-sided and the significant level will be set at 005 All the analysis will be conducted using the Statistical Package for Social Sciences SPSS software version 22
This procedure is always associated with varying degrees of postoperative pain and swelling that may have a social impact Traditionally rotating instruments like burs have been used for osseous surgery
Piezosurgery is a novel technique introduced to overcome the disadvantages associated with the conventional rotatory technique Corticosteroids administration before or after the extraction of third molars is an efficient way to minimize postoperative pain due to their strong anti-inflammatory activity
Many researchers conducted studies comparing the piezosurgery technique with conventional rotatory technique regarding postoperative pain and working time or studies comparing the conventional method with or without dexamethasone injection Only one recent study Nov 2018 conducted by Gümrükçü Z et al has compared Piezosurgery and dexamethasone injection in third molar surgery but without evaluating the combined effect of these two techniques on postoperative pain
Objectives The objective of this study is to assess the effects of piezosurgery technique and intramuscular dexamethasone injection on postoperative pain in impacted third molar surgery
Methods The study design is a randomized controlled clinical trial 80 patients with mandibular third molar impaction indicated for surgical extraction should be treated randomly using either the piezosurgery or the conventional rotatory technique and with or without intramuscular dexamethasone injection Postoperative pain will be assessed using a visual analog scale VAS on days 1 3 and seven postoperatively
The differences in Post-operative pain within and between study groups 4 groups will be tested using repeated measures of analysis of variance ANOVA or Friedman tests Differences in working time among the three techniques will be assessed using a repeated measure of ANOVA All statistical tests will be two-sided and the significant level will be set at 005 All the analysis will be conducted using the Statistical Package for Social Sciences SPSS software version 22
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None