Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques

NCT03156387 | Completed

• 1 other identifier: 2015-KAEK-86/05
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

High Frenum Attachment

Keywords

diode laser; scalpel surgery; frenectomy; postoperative complications

Outcome Measures

Primary Outcomes (1)

• postoperative degrees of pain

  visual analog scale (0 to 10 cm)

  Change from postoperative first week at postoperative third month

Secondary Outcomes (2)

• plague index

  preoperative

• functional complications

  Change from postoperative first week at postoperative third month

Study Arms (2)

Diode laser

EXPERIMENTAL

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

Scalpel

ACTIVE COMPARATOR

(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

Interventions

Diode laser PROCEDURE

2.8 W diode laser surgery were applied on high frenulum attachment and follow-up VAS scores were evaluated

Also known as: Sirona Advanced

Diode laser

Scalpel PROCEDURE

Scalpel surgery were performed after local anesthetic administration and VAS scores were recorded.

Scalpel

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• T.C. Dumlupınar Üniversitesi: lead

Related Publications (3)

• Vescovi P, Corcione L, Meleti M, Merigo E, Fornaini C, Manfredi M, Bonanini M, Govoni P, Rocca JP, Nammour S. Nd:YAG laser versus traditional scalpel. A preliminary histological analysis of specimens from the human oral mucosa. Lasers Med Sci. 2010 Sep;25(5):685-91. doi: 10.1007/s10103-010-0770-4.

  PMID: 20393771 BACKGROUND

• Fornaini C, Rocca JP, Bertrand MF, Merigo E, Nammour S, Vescovi P. Nd:YAG and diode laser in the surgical management of soft tissues related to orthodontic treatment. Photomed Laser Surg. 2007 Oct;25(5):381-92. doi: 10.1089/pho.2006.2068.

  PMID: 17975951 BACKGROUND

• Romanos G, Nentwig GH. Diode laser (980 nm) in oral and maxillofacial surgical procedures: clinical observations based on clinical applications. J Clin Laser Med Surg. 1999 Oct;17(5):193-7. doi: 10.1089/clm.1999.17.193.

  PMID: 11199822 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Lasers, Semiconductor; Laser Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ahu Uraz, PhD Dr

  Gazi University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: February 1, 2015
• Primary Completion: June 30, 2015
• Study Completion: May 10, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share