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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gigaa Cheese 810 nm Diode Laser | Device | Diode Laser assisted frenectomy operation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| C562489 | Lymphoid Interstitial Pneumonia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Conventional Frenectomy Operation | Procedure | Frenectomy operation performed by surgical blades with suturing. |
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