Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

January 27, 2020 updated by: Marwa Gamaleldin Marei Noureldin, Alexandria University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 00203
        • Faculty of dentistry-Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 52 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: cyst enucleation using piezosurgery
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.
Other: PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments
ACTIVE_COMPARATOR: cyst enucleation using conventional surgery
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.
Other: PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of operation in minutes
Time Frame: Intraoperative
Time from start of the incision to the last suture.
Intraoperative
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)
Intraoperative
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".
1 month
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

November 16, 2019

Study Completion (ACTUAL)

January 18, 2020

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (ACTUAL)

January 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Piezosurgery cyst enucleation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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