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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02711501
Enrollment
14
Registered
2016-03-17
Start date
2016-03-31
Completion date
2016-05-31
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Keywords

post-operative pain, diode laser

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.

Interventions

PROCEDURELaser-assisted surgery.

laser-assisted surgery

PROCEDUREconventional surgery by blade

conventional surgery

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
post-operative swelling intensityWithin the first 6 days after surgerySwelling 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

MeasureTime frameDescription
post-operative pain intensityWithin the first 6 days after surgeryPostoperative pain was measured using a visual analog scale (VAS) ranging from zero for no pain to 100 for the worst possible pain.(questionnaire)
implant success3 months laterbased on Albrektsson success criteria.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026