Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

RADICULAR CYSTS Clinical Trial

Official title:

Clinical And Radiographic Outcomes Of Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244422
• Other study ID #: Piezosurgery cyst enucleation
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 18, 2020

Study information

• Verified date: January 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 18, 2020
• Est. primary completion date: November 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• RADICULAR CYSTS

Intervention

Other:
• PIEZOSURGERY VERSUS CONVENTIONAL SURGERY
Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments

Locations

Country	Name	City	State
Egypt	Faculty of dentistry-Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of operation in minutes	Time from start of the incision to the last suture.	Intraoperative
Primary	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)	Intraoperative
Primary	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".	1 month
Primary	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	3 months