Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

Not Applicable

Completed

• Conditions: RADICULAR CYSTS
• Interventions: Other: PIEZOSURGERY VERSUS CONVENTIONAL SURGERY

• Registration Number: NCT04244422
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-11-16
• Status Verified: 2020-01
• Study Completion: 2020-01-18
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-27
• Last Update Submitted: 2020-01-27
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cyst enucleation using piezosurgery	PIEZOSURGERY VERSUS CONVENTIONAL SURGERY	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.
cyst enucleation using conventional surgery	PIEZOSURGERY VERSUS 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.

Primary Outcome Measures

Name	Time	Method
Time of operation in minutes	Intraoperative	Time from start of the incision to the last suture.
Radiographic percentage of change in bone defect volume using cone beam computed tomography	3 months	The change between preoperative and 3-months postoperative values of both groups were compared
Hemorrhage control and ease of operation using a visual analogue scale	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)	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".

Trial Locations

Locations (1)

Faculty of dentistry-Alexandria University; 🇪🇬 Alexandria, Egypt