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Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques

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ClinicalTrials.gov Identifier: NCT03156387
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Berceste Guler, T.C. Dumlupınar Üniversitesi

Brief Summary:
The aim of present study was to compare the keratinized gingival tissue measurements, degree of subjective complaints, and functional complications of using an 980 nm diode laser versus a scalpel for frenectomies. Thirty-six patients requiring frenectomies, between 18 and 51 years old, were randomly assigned to either scalpel or diode laser treatments. The soft tissue measurements, including the keratinized gingiva width (KGW), attached gingiva width(AGW), and attached gingiva thickness (AGT), were recorded before surgery, immediately after, one week later, and one, three, and six months after surgery. In addition, the functional complications and the morbidity (level of pain, swelling, and redness) were evaluated during the first postoperative week using a visual analog scale (VAS). The VAS scores indicated that the patients treated with a diode laser had less discomfort and functional complications compare with scalpel surgery.

Condition or disease Intervention/treatment Phase
High Frenum Attachment Procedure: Diode laser Procedure: Scalpel Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
Procedure: Scalpel
Scalpel surgery were performed after local anesthetic administration and VAS scores were recorded.




Primary Outcome Measures :
  1. postoperative degrees of pain [ Time Frame: Change from postoperative first week at postoperative third month ]
    visual analog scale (0 to 10 cm)


Secondary Outcome Measures :
  1. plague index [ Time Frame: preoperative ]
    between 0 to 4 scale

  2. functional complications [ Time Frame: Change from postoperative first week at postoperative third month ]
    visual analog scale (0 to 10 cm)



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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Those subjects with maxillary anterior frenula extending to the interdental papilla of the central incisors, those undergoing frenectomies for orthodontic, prosthodontic, or periodontal treatment and those with no surgical contraindications were included in this study.

Exclusion Criteria:

  • The patients were excluded if they exhibited poor oral hygiene, received periodontal therapy, were being treated with antibiotics, anti-inflammatories, or analgesics during the previous three months, or if they had any systemic conditions that could affect oral surgery.

Information from the National Library of Medicine

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


Sponsors and Collaborators
T.C. Dumlupınar Üniversitesi
Investigators
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Study Director: Ahu Uraz, PhD Dr Gazi University Faculty of Dentistry

Publications:
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Responsible Party: Berceste Guler, Clinical Investigator, T.C. Dumlupınar Üniversitesi
ClinicalTrials.gov Identifier: NCT03156387    
Other Study ID Numbers: 2015-KAEK-86/05
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The patients will be 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berceste Guler, T.C. Dumlupınar Üniversitesi:
diode laser
scalpel surgery
frenectomy
postoperative complications