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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03552809
Enrollment
48
Registered
2018-06-12
Start date
2016-09-30
Completion date
2017-10-31
Last updated
2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frenulum; Hypertrophy, Lip

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.

Interventions

DEVICEGigaa Cheese 810 nm Diode Laser

Diode Laser assisted frenectomy operation.

PROCEDUREConventional Frenectomy Operation

Frenectomy operation performed by surgical blades with suturing.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain ChangePostoperative 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026