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Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

Primary Purpose

RADICULAR CYSTS

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RADICULAR CYSTS

Eligibility Criteria

31 Years - 52 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1) Patients with systemic diseases contraindicating surgery
  • 2) Cases in suspicion of malignancy

Sites / Locations

  • Faculty of dentistry-Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

cyst enucleation using piezosurgery

cyst enucleation using conventional surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time of operation in minutes
Time from start of the incision to the last suture.
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)
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".
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

Secondary Outcome Measures

Full Information

First Posted
January 22, 2020
Last Updated
January 27, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04244422
Brief Title
Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
Official Title
Clinical And Radiographic Outcomes Of Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 16, 2019 (Actual)
Study Completion Date
January 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RADICULAR CYSTS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cyst enucleation using piezosurgery
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cyst enucleation using conventional surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
Intervention Description
Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments
Primary Outcome Measure Information:
Title
Time of operation in minutes
Description
Time from start of the incision to the last suture.
Time Frame
Intraoperative
Title
Hemorrhage control and ease of operation using a visual analogue scale
Description
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)
Time Frame
Intraoperative
Title
Objective assessment of neurosensory function using a probe (to detect nerve injury after the surgeries)
Description
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".
Time Frame
1 month
Title
Radiographic percentage of change in bone defect volume using cone beam computed tomography
Description
The change between preoperative and 3-months postoperative values of both groups were compared
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1) Patients with systemic diseases contraindicating surgery 2) Cases in suspicion of malignancy
Facility Information:
Facility Name
Faculty of dentistry-Alexandria University
City
Alexandria
ZIP/Postal Code
00203
Country
Egypt

12. IPD Sharing Statement

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Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

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