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Completed

NCT Number: NCT02711501

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

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neda Moslemi, Tehran, Tehran Province, Iran

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laser-assisted surgery.

Procedure

laser-assisted surgery

conventional surgery by blade

Procedure

conventional surgery

Primary outcomes

  1. post-operative swelling intensity

    Time frame: 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 outcomes

  1. post-operative pain intensity

    Time frame: 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)

  2. implant success

    Time frame: 3 months later

    based on Albrektsson success criteria.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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