Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel

Study Overview
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Brief Summary
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The aim of this study was to investigate if using lasers instead of scalpel for flap advancement in bone augmentation procedures would reduce post-operative swelling and pain.

Detailed Description
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Guided bone regeneration (GBR) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. Primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key factor for tension free primary wound closure. The tension free flap is usually attained by incising the buccal flap using scalpels. However, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. Swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life. Currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. The major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.

Conditions
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Post-operative Pain

Intervention / Treatment
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* Procedure: Laser-assisted surgery.
* Procedure: conventional surgery by blade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR Exclusion Criteria: general contraindication for bone augmentation or implant surgeries, existence of swelling or pain at the time of surgery, smoking habits, pregnancy, and lactation.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser irradiation<br>laser-assisted surgery with the following parameters: Wavelength:810 nanometer, power: 3 W, pulse mode,pulse length 100 µs, pulse interval 200 µs | Procedure: Laser-assisted surgery.<br>* laser-assisted surgery<br>|
| Experimental: blade<br>conventional surgery by blade | Procedure: conventional surgery by blade<br>* conventional surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative swelling intensity | Swelling on the operated side was evaluated as follows: 0 (none: no inflammation), 1 (mild: intraoral swelling confined to the surgical field), 2 (moderate: extra oral swelling in the surgical zone), or 3 (intense: extra oral swelling spreading beyond the surgical zone). | Within the first 6 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain intensity | Postoperative pain was measured using a visual analog scale (VAS) ranging from zero for no pain to 100 for the worst possible pain.(questionnaire) | Within the first 6 days after surgery | 
| implant success | based on Albrektsson success criteria. | 3 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-operative pain, diode laser