Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations

NCT03552809 | Completed

• 1 other identifier: Cetinkaya et al.
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment. Forty-eight patients with high papillary frenulum attachments were included in the study. Patients were randomly divided into three groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum (Group L+P). Postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS). Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days. Plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days. All data were compared between groups and within each group.

Conditions

Frenulum; Hypertrophy, Lip

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Change

  Postoperative pain during eating and speaking will be evaluate via visual analog scale (VAS).Visual Analogue Scale (VAS) was used to evaluate pain, discomfort during speaking and chewing. VAS consisted of a horizontal line with a range of numbers from '0' to '10' of which '0' means 'no pain' and '10' means unbearable pain.

  Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.

Study Arms (3)

Conventional Frenectomy

ACTIVE COMPARATOR

For the conventional surgery, after application of local infiltration anesthesia of articaine HCL associated with epinephrine 1:100,000, the frenulum was grasped with a straight haemostat inserted into the depth of the vestibule; the tissue adjacent to the upper and lower surfaces of the haemostat was incised with a no.15 scalpel. After the diamond shaped resected portion of the frenulum was removed with the haemostat, muscle dilatations were excised on the submucosa of the lateral walls of the cavity. Horizontal incision was made on the periosteum with the help of a scalpel following the procedure. At the end of the operation, the wound was closed with absorbable sutures (4-0, Pegelak®, Doğsan Turkey).

Procedure: Conventional Frenectomy Operation

Diode Laser Frenectomy

EXPERIMENTAL

For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure. The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000. The frenlum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre). The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum or any bone structure.Following the bleeding control, the wound site was left to secondary healing. No sutures were necessary after procedure.

Device: Gigaa Cheese 810 nm Diode Laser

Laser Frenectomy with Incision

EXPERIMENTAL

For the laser frenectomy, a diode laser device (λ = 810 nm, W: 4, GIGA Cheese II, China) was used to perform the procedure. The procedure was performed under local infiltration anesthesia with articaine HCL associated with epinephrine 1:100,000. The frenulum was held by a haemostat inserted into the depth of the vestibule while laser energy was applied to the upper and lower parts of the frenulum adjacent to the haemostat via a fibre tip (400 µm diameter, plain-ended, optical fibre). The laser was carefully applied to the tissue and care was taken to avoid local necrosis of the periosteum. Horizontal incision was made on the periosteum with the help of a scalpel, additionally. No sutures were necessary after procedure.

Device: Gigaa Cheese 810 nm Diode Laser

Interventions

Gigaa Cheese 810 nm Diode Laser DEVICE

Diode Laser assisted frenectomy operation.

Diode Laser Frenectomy; Laser Frenectomy with Incision

Conventional Frenectomy Operation PROCEDURE

Frenectomy operation performed by surgical blades with suturing.

Conventional Frenectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to Mirko et al (Mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study.

You may not qualify if:

• Any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, HIV infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Hypertrophy; Lymphoid Interstitial Pneumonia

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: June 12, 2018
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06