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

Not Applicable

Completed

• Conditions: Post-operative Pain
• Interventions: Procedure: conventional surgery by blade; Procedure: Laser-assisted surgery.

• Registration Number: NCT02711501
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-02-04
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-17
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-10
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
blade	conventional surgery by blade	conventional surgery by blade
Laser irradiation	Laser-assisted surgery.	laser-assisted surgery with the following parameters: Wavelength:810 nanometer, power: 3 W, pulse mode,pulse length 100 µs, pulse interval 200 µs

Primary Outcome Measures

Name	Time	Method
post-operative swelling intensity	Within the first 6 days after surgery	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).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of

Neda Moslemi; 🇮🇷 Tehran, Iran, Islamic Republic of