RADICULAR CYSTSNCT04244422
Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
A study testing PIEZOSURGERY VERSUS CONVENTIONAL SURGERY in people with RADICULAR CYSTS, run by Alexandria University at 1 site in Egypt.
Trial summary
AIM: The study was intended to evaluate the effectiveness of piezosurgery in enucleation of radicular odontogenic cysts in comparison to the conventional technique from both the clinical and radiographic perspectives. Read more about this study
- Who is it for?
- Ages 31 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- RADICULAR CYSTS
- What is being tested?
- PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 18 Jan 2020
- Phase
- Interventional
- 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 31 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Periapical cysts involving more than one tooth in close relation to the maxillary sinus, nasal cavity or inferior alveolar neurovascular bundle,
- 2) Intact labial/buccal cortical plate with no perforation.
Who cannot join
- 1) Patients with systemic diseases contraindicating surgery
- 2) Cases in suspicion of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical And Radiographic Outcomes Of Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
AIM: The study was intended to evaluate the effectiveness of piezosurgery in enucleation of radicular odontogenic cysts in comparison to the conventional technique from both the clinical and radiographic perspectives.
Read the detailed description
METHODS: Fourteen (8 females and 6 males) patients with age range of 30-55 years who had radicular cysts associated with non-vital teeth, were operated at the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. The patients were randomly divided into 2 groups;1) the study group (7 patients) in which cyst enucleation using piezosurgery was employed, 2) control group in which the cysts were removed using the conventional technique. The following parameters were assessed; postoperative pain, time of operation, hemorrhage control and field visibility, ease of operation, neurosensory evaluation and radiographic percentage of change in bone defect volume between preoperative and 3-months postoperative values.
- Conditions
- RADICULAR CYSTS
- Being tested
- PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
- Medical subject headings
- Radicular Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIEZOSURGERY VERSUS CONVENTIONAL SURGERYOther
Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments
| Study group | Role | What they receive |
|---|---|---|
| cyst enucleation using piezosurgery | Active comparator | SATLEC ACTEON peizotome 2 was used for bone cutting and separating the cystic lining from the surrounding bone.After complete removal of the cyst, the bony window was replaced back in place and the flap was sutured. Receives: Other: PIEZOSURGERY VERSUS CONVENTIONAL SURGERY |
| cyst enucleation using conventional surgery | Active comparator | A carbide bur was used to remove the bone to uncover the cyst. A periosteal elevator and a curette were used to aid in the removal of the cystic lesion. Receives: Other: PIEZOSURGERY VERSUS CONVENTIONAL SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of operation in minutes
Time from start of the incision to the last suture.
Measured: Intraoperative
Hemorrhage control and ease of operation using a visual analogue scale
To assess the visibility of the field and ease of operation, a visual analogue scale was used. Each parameter constituted a horizontal 100 mm continuous line in which value of zero indicates minimum level of the assessed parameter and 100 indicates the maximum level. Each surgeon marked on the line then the score is determined by measuring in mms from the left end of the line to that marked point. (higher scores mean a better outcome)
Measured: Intraoperative
Objective assessment of neurosensory function using a probe (to detect nerve injury after the surgeries)
A probe was used to prick the patient's skin relevant to the area of operation to assess the neurosensory function in comparison to the contralateral side.If the patient states a difference in sensation between the side of operation and the normal side, it was assigned as "Y" and if there was no difference in sensation between the two sides, it was assigned as "N".
Measured: 1 month
Radiographic percentage of change in bone defect volume using cone beam computed tomography
The change between preoperative and 3-months postoperative values of both groups were compared
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Sep 2018
- Primary completion16 Nov 2019
- Study completion18 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RADICULAR CYSTSStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Gamaleldin Marei Noureldin, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244422
- Sponsor's protocol ID
- Piezosurgery cyst enucleation
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Outcomes Of Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
- ClinicalTrials.gov ID
- NCT04244422
- Acronym / sponsor ID
- Piezosurgery cyst enucleation
- Conditions
- RADICULAR CYSTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 16 Nov 2019 (actual)
- Study completion
- 18 Jan 2020 (actual)
- First posted
- 28 Jan 2020 (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.
AIM: The study was intended to evaluate the effectiveness of piezosurgery in enucleation of radicular odontogenic cysts in comparison to the conventional technique from both the clinical and radiographic perspectives.
Detailed description
METHODS: Fourteen (8 females and 6 males) patients with age range of 30-55 years who had radicular cysts associated with non-vital teeth, were operated at the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. The patients were randomly divided into 2 groups;1) the study group (7 patients) in which cyst enucleation using piezosurgery was employed, 2) control group in which the cysts were removed using the conventional technique. The following parameters were assessed; postoperative pain, time of operation, hemorrhage control and field visibility, ease of operation, neurosensory evaluation and radiographic percentage of change in bone defect volume between preoperative and 3-months postoperative values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyst enucleation using piezosurgery | Active comparator | Other: PIEZOSURGERY VERSUS CONVENTIONAL SURGERYSATLEC ACTEON peizotome 2 was used for bone cutting and separating the cystic lining from the surrounding bone.After complete removal of the cyst, the bony window was replaced back in place and the flap was sutured. |
| cyst enucleation using conventional surgery | Active comparator | Other: PIEZOSURGERY VERSUS CONVENTIONAL SURGERYA carbide bur was used to remove the bone to uncover the cyst. A periosteal elevator and a curette were used to aid in the removal of the cystic lesion. |
Who may qualify
- Ages
- 31 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1) Periapical cysts involving more than one tooth in close relation to the maxillary sinus, nasal cavity or inferior alveolar neurovascular bundle,
- 2) Intact labial/buccal cortical plate with no perforation.
Key exclusion criteria (2 listed)
- 1) Patients with systemic diseases contraindicating surgery
- 2) Cases in suspicion of malignancy
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 |
|---|---|---|
| PIEZOSURGERY VERSUS CONVENTIONAL SURGERYPiezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments | Other | cyst enucleation using conventional surgery, cyst enucleation using piezosurgery |
Primary outcome
Time of operation in minutes
Time frame: Intraoperative
Time from start of the incision to the last suture.
Hemorrhage control and ease of operation using a visual analogue scale
Time frame: Intraoperative
To assess the visibility of the field and ease of operation, a visual analogue scale was used. Each parameter constituted a horizontal 100 mm continuous line in which value of zero indicates minimum level of the assessed parameter and 100 indicates the maximum level. Each surgeon marked on the line then the score is determined by measuring in mms from the left end of the line to that marked point. (higher scores mean a better outcome)
Objective assessment of neurosensory function using a probe (to detect nerve injury after the surgeries)
Time frame: 1 month
A probe was used to prick the patient's skin relevant to the area of operation to assess the neurosensory function in comparison to the contralateral side.If the patient states a difference in sensation between the side of operation and the normal side, it was assigned as "Y" and if there was no difference in sensation between the two sides, it was assigned as "N".
Radiographic percentage of change in bone defect volume using cone beam computed tomography
Time frame: 3 months
The change between preoperative and 3-months postoperative values of both groups were compared
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 28 Jan 2020.
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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 study testing PIEZOSURGERY VERSUS CONVENTIONAL SURGERY in people with RADICULAR CYSTS, run by Alexandria University at 1 site in Egypt.
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 2 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 28 Jan 2020. 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 Egypt. 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.
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?
Time of operation in minutes (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2020.