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Completed

NCT Number: NCT04244422

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.

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Key information

Conditions

RADICULAR CYSTS Bone Cysts Cysts Jaw Cysts Jaw Diseases Mouth Diseases Musculoskeletal Diseases Neoplasms Odontogenic Cysts Periapical Diseases Periodontal Cyst Periodontal Diseases Radicular Cyst Stomatognathic Diseases

Age range

31 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry-Alexandria University

Alexandria, 00203, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PIEZOSURGERY VERSUS CONVENTIONAL SURGERY

Other

Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments

Primary outcomes

  1. Time of operation in minutes

    Time frame: Intraoperative

    Time from start of the incision to the last suture.

  2. 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)

  3. 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".

  4. 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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