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

Post-operative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711501
• Other study ID #: TehranUMS h4p62mb2
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: September 10, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Postoperative Complications

Intervention

Procedure:
• Laser-assisted surgery.
laser-assisted surgery
• conventional surgery by blade
conventional surgery

Locations

Country	Name	City	State
Iran, Islamic Republic of	Neda Moslemi	Tehran
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	implant success	based on Albrektsson success criteria.	3 months later	Yes