Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques

High Frenum Attachment Clinical Trial

Official title:

Patient Perceptions and Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156387
• Other study ID #: 2015-KAEK-86/05
• Status: Completed
• Phase: N/A
• First received: May 15, 2017
• Last updated: May 15, 2017
• Start date: February 1, 2015
• Est. completion date: May 10, 2017

Study information

• Verified date: May 2017
• Source: T.C. Dumlupinar Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 10, 2017
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 51 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Frenum Attachment

Intervention

Procedure:
• Diode laser
2.8 W diode laser surgery were applied on high frenulum attachment and follow-up VAS scores were evaluated
• Scalpel
Scalpel surgery were performed after local anesthetic administration and VAS scores were recorded.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
T.C. Dumlupinar Üniversitesi

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative degrees of pain	visual analog scale (0 to 10 cm)	Change from postoperative first week at postoperative third month
Secondary	plague index	between 0 to 4 scale	preoperative
Secondary	functional complications	visual analog scale (0 to 10 cm)	Change from postoperative first week at postoperative third month