Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03156387|
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|High Frenum Attachment||Procedure: Diode laser Procedure: Scalpel||Not Applicable|
The whole mouth records of each participant served as a basis for the clinical periodontal diagnoses. Prior to the frenectomy, the same investigator recorded the following parameters: plaque index (PLI), gingival index (GI), pocket probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP). All of the clinical parameters were measured at six sites per tooth (mesio, mid, and distobuccal, and mesio, mid, and distopalatal) using a Williams periodontal probe (Nordent Manufacturing Inc., Elk Grove Village, IL, USA) calibrated in millimeters.
The patients were instructed to record the postoperative degrees of pain, redness, swelling, and functional complications, including chewing and speech, on a 10 cm horizontal visual analog scale (VAS), by placing a vertical mark between the two endpoints, from the first through seventh days. The scale was graded from left to right with values ranging from "0" (no pain, functional complications, discomfort, swelling, or redness) to "10" (worst pain, extreme functional complications, extreme discomfort, extreme swelling, and extreme redness). The keratinized gingiva width (KGW), attached gingiva width (AGW), and attached gingiva thickness (AGT) were also recorded before the surgery. Postoperative analyses were performed at four separate times: immediately, at the first week, and at the first and third months after surgery. The patients in each group were also asked if they required anesthesia during the operation and analgesics after the operation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study, designed as a randomized prospective controlled clinical trial, was conducted to compare the clinical outcomes of frenectomies performed using conventional surgery or a diode laser.|
|Masking:||None (Open Label)|
|Official Title:||Patient Perceptions and Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||June 30, 2015|
|Actual Study Completion Date :||May 10, 2017|
Experimental: Diode laser
A 2.8 W, 980 nm diode laser(Sirona Advanced) in continuous wave mode with an air cooling handpiece was used in the alternative frenectomy technique. The frenulum was held with a hemostat, and a repeated continuous wave mode was applied for the excision. It was also used to remove the periosteal adhesion. The remnants of the ablated tissue were removed with saline, and no sutures were placed after the diode laser treatment.
Procedure: Diode laser
2.8 W diode laser surgery were applied on high frenulum attachment and follow-up VAS scores were evaluated
Other Name: Sirona Advanced
Active Comparator: Scalpel
(1) topical anesthesia (20% benzocaine), (2) local anesthesia using the bilateral vestibular infiltration technique, with 0.6 ml (1/3 of the carpule contents) of 4% articaine and 1:200,000 epinephrine, (3) hemostatic clamping of the frenulum, (4) excision of the whole band of tissue, together with its alveolar attachment, with a 15C scalpel blade, (5) relaxation and unbending of any fibrous adhesions to the underlying periosteum, and (6) simple suturing with 5-0 silk thread
Scalpel surgery were performed after local anesthetic administration and VAS scores were recorded.
- postoperative degrees of pain [ Time Frame: Change from postoperative first week at postoperative third month ]visual analog scale (0 to 10 cm)
- plague index [ Time Frame: preoperative ]between 0 to 4 scale
- functional complications [ Time Frame: Change from postoperative first week at postoperative third month ]visual analog scale (0 to 10 cm)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156387
|Study Director:||Ahu Uraz, PhD Dr||Gazi University Faculty of Dentistry|