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

• ClinicalTrials.gov Identifier: NCT03552809
• Recruitment Status: Completed
• First Posted: June 12, 2018
• Last Update Posted: June 12, 2018
• Sponsor: Marmara University
• Information provided by (Responsible Party): Marmara University

Tracking Information

• First Submitted Date: March 31, 2018
• First Posted Date: June 12, 2018
• Last Update Posted Date: June 12, 2018
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 9, 2018)

Postoperative Pain Change [ Time Frame: Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days. ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
• Official Title: Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Frenulum; Hypertrophy, Lip

Intervention

• Device: Gigaa Cheese 810 nm Diode Laser
  Diode Laser assisted frenectomy operation.
• Procedure: Conventional Frenectomy Operation
  Frenectomy operation performed by surgical blades with suturing.

Study Arms

• Active Comparator: Conventional Frenectomy
  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).
  Intervention: Procedure: Conventional Frenectomy Operation
• Experimental: Diode Laser Frenectomy
  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.
  Intervention: Device: Gigaa Cheese 810 nm Diode Laser
• Experimental: Laser Frenectomy with Incision
  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.
  Intervention: Device: Gigaa Cheese 810 nm Diode Laser

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 9, 2018): 48
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2017
• Actual Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03552809
• Other Study ID Numbers: Cetinkaya et al.
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Marmara University
• Study Sponsor: Marmara University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Marmara University
• Verification Date: June 2018