Impacted Mandibular Third Molar ExtractionPhase 4NCT04889781
Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery
A Phase 4 study testing Dexamethasone injection, Piezosurgery and Conventional Rotatory instruments in people with Impacted Mandibular Third Molar Extraction, run by Central Military Healthcare - Oral and Maxillofacial Surgery Department at 1 site in Lebanon.
Trial summary
The purpose of my study is to test the effect of using piezosurgery and dexamethasone injection in the surgical extraction of impacted mandibular third molars, on Postoperative Pain. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction
- What is being tested?
- Dexamethasone injection, Piezosurgery and Conventional Rotatory instruments
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Feb 2019to 1 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age from 15 to 30 years,
- Having mandibular impacted third molars,
Who cannot join
- Heavy smokers (≥20 cigarettes),
- Uncontrolled systemic conditions,
- Infection of the surgery site,
- Psychological problems,
- History of allergy to dexamethasone, amoxicillin, or acetaminophen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery: A Randomized Clinical Trial
The purpose of my study is to test the effect of using piezosurgery and dexamethasone injection in the surgical extraction of impacted mandibular third molars, on Postoperative Pain.
Read the 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 0.05. All the analysis will be conducted using the Statistical Package for Social Sciences (SPSS) software version 22.
- Being tested
- Dexamethasone injection, Piezosurgery, Conventional Rotatory instruments
- Keywords
- Impacted Mandibular Third molar surgery., Pain, Dexamethasone, Piezosurgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone injectionDrug
Compare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery
PiezosurgeryProcedure or surgery
Compare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery
Conventional Rotatory instrumentsProcedure or surgery
Surgical extraction using conventional rotatory instruments to perform osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Rotatory Instruments without Dexamethasone injection | Experimental | Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy without Intramuscular Dexamethasone injection Receives: Procedure: Conventional Rotatory instruments |
| Rotatory Instruments with Dexamethasone injection | Experimental | Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy with 8 mg Intramuscular Dexamethasone injection 30 min before surgery Receives: Drug: Dexamethasone injection |
| Piezosurgery technique without Dexamethasone injection | Experimental | Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection Receives: Procedure: Piezosurgery; Procedure: Conventional Rotatory instruments |
| Piezosurgery technique with Dexamethasone injection | Experimental | Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery Receives: Drug: Dexamethasone injection; Procedure: Piezosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Postoperative Pain level From Baseline
Postoperative Pain level using Visual Analogue Scale (VAS): 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain
Measured: Days 1, 3, and 7 Post-op
Working time
Surgery time from the start of the incision until the end of the suturing (min).
Measured: Per-op
Secondary outcomes (1)
Change oh The maximal mouth opening From Baseline
The maximal mouth opening, previously taken at Day 0 was measured at day three post-op, and expressed in millimeters (mm).
Measured: At Day 0 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Feb 2019
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Military Healthcare - Oral and Maxillofacial Surgery Department
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wissam Nehme, Central Military Healthcare - Oral and Maxillofacial Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889781
- Sponsor's protocol ID
- REF 16/02/2019
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nehme W, Fares Y, Abou-Abbas L. Piezo-surgery technique and intramuscular dexamethasone injection to reduce postoperative pain after impacted mandibular third molar surgery: a randomized clinical trial. BMC Oral Health. 2021 Aug 11;21(1):393. doi: 10.1186/s12903-021-01759-x.
PubMed 34380473
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04889781
- Acronym / sponsor ID
- REF 16/02/2019
- Keywords
- Impacted Mandibular Third molar surgery., Pain, Dexamethasone, Piezosurgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Central Military Healthcare - Oral and Maxillofacial Surgery DepartmentOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of my study is to test the effect of using piezosurgery and dexamethasone injection in the surgical extraction of impacted mandibular third molars, on Postoperative Pain.
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 0.05. All the analysis will be conducted using the Statistical Package for Social Sciences (SPSS) software version 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rotatory Instruments without Dexamethasone injection | Experimental | Procedure: Conventional Rotatory instrumentsSurgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy without Intramuscular Dexamethasone injection |
| Rotatory Instruments with Dexamethasone injection | Experimental | Drug: Dexamethasone injectionSurgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy with 8 mg Intramuscular Dexamethasone injection 30 min before surgery |
| Piezosurgery technique without Dexamethasone injection | Experimental | Procedure: Piezosurgery, Procedure: Conventional Rotatory instrumentsSurgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection |
| Piezosurgery technique with Dexamethasone injection | Experimental | Drug: Dexamethasone injection, Procedure: PiezosurgerySurgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age from 15 to 30 years,
- Having mandibular impacted third molars,
Key exclusion criteria (5 listed)
- Heavy smokers (≥20 cigarettes),
- Uncontrolled systemic conditions,
- Infection of the surgery site,
- Psychological problems,
- History of allergy to dexamethasone, amoxicillin, or acetaminophen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone injectionCompare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery | Drug | Piezosurgery technique with Dexamethasone injection, Rotatory Instruments with Dexamethasone injection |
| PiezosurgeryCompare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery | Procedure or surgery | Piezosurgery technique with Dexamethasone injection, Piezosurgery technique without Dexamethasone injection |
| Conventional Rotatory instrumentsSurgical extraction using conventional rotatory instruments to perform osteotomy | Procedure or surgery | Piezosurgery technique without Dexamethasone injection, Rotatory Instruments without Dexamethasone injection |
Primary outcome
Change of Postoperative Pain level From Baseline
Time frame: Days 1, 3, and 7 Post-op
Postoperative Pain level using Visual Analogue Scale (VAS): 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain
Working time
Time frame: Per-op
Surgery time from the start of the incision until the end of the suturing (min).
1 secondary outcome
Change oh The maximal mouth opening From Baseline
Time frame: At Day 0 and Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 34380473Nehme W, Fares Y, Abou-Abbas L. Piezo-surgery technique and intramuscular dexamethasone injection to reduce postoperative pain after impacted mandibular third molar surgery: a randomized clinical trial. BMC Oral Health. 2021 Aug 11;21(1):393. doi: 10.1186/s12903-021-01759-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone injection, Piezosurgery and Conventional Rotatory instruments in people with Impacted Mandibular Third Molar Extraction, run by Central Military Healthcare - Oral and Maxillofacial Surgery Department at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Postoperative Pain level From Baseline (time frame: Days 1, 3, and 7 Post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.