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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.
Children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. During the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. Wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. Three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. The patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scalpel | Active Comparator | Frenotomy performed with conventional scalpel |
|
| Er:YAG laser | Experimental | Frenotomy performed with Er:YAG laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalpel | Device | Labial frenulum removed by scalpel |
| |
| Er:YAG laser |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Time period until reepithelialized measured clinically and on photos | 0-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient experience | Patients´experiences of surgery procedures measured through questionnaires | 0-3 months |
| Time required for surgery | The time required for the surgical process is measured with timer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Dental Service, Vretgränd 9 | Uppsala | SE-75017 | Sweden |
Individual participant data are not planned to be shared
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D007834 | Lasers |
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Prospective, randomized, controlled, single-blind investigation
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The outcome assessor have not met the patient before assessing the outcome. The assessor has no information about which surgical technique that is used.
| Device |
Labial frenulum removed by Er:YAG laser |
|
| Intervention day |
| Scar tissue formation | prevalence of scar tissue formation assessed by a clinical investigation | 3 months |
| D055096 |
| Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |