Clinical trial NCT03156387: Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques
Official title: Patient Perceptions and Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Frenum Attachment
Keywords: diode laser
scalpel surgery
frenectomy
postoperative complications
Lead sponsor: T.C. Dumlupınar Üniversitesi
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: postoperative degrees of pain
timeFrame: Change from postoperative first week at postoperative third month
Secondary outcomes:
measure: plague index
timeFrame: preoperative
measure: functional complications
timeFrame: Change from postoperative first week at postoperative third month
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University Faculty of Dentistry
name: Ahu Uraz, PhD Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.