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NCT Number: NCT06231134

Diode Laser 940 Nm Versus Electrosurgical Device During Second Stage Implant Surgery on Bone and Soft Tissue Healing

Background: Dental lasers and electrosurgical devices have been introduced a long time ago. However, limited studies are available concerning their use in the second stage of implant surgery, with the conventional surgical technique being the standard of care.

Aim of this study: To evaluate clinically and radiographically soft and hard tissue healing associated with the use of electrosurgical and laser devices and compare them with conventional surgical techniques during second-stage implant surgery.

Plan of the study: A randomized controlled clinical trial. The sample size will include patients who have an implant already placed and ready for second stage surgery recruited from the patient pool at the outpatient clinics.

Materials and Methods: Patients will be randomly allocated into the three groups. In Group (A) implant will be exposed using the conventional surgical exposure techniques with a tissue punch, the cover screw will be removed, and the healing abutment placed. In group (B) implant will be uncovered using a diode laser (940nm) in contact type with a continuous mode at a power of 1.5 watts, the laser tip will be used in a circular motion to create a small opening which will be increased till large enough to expose and remove the cover screw and place the healing abutments. In group (C) the monopolar electrosurgical device will be used in the same way as the laser tip with additional care avoiding contacting the implants during exposure.

The outcome: will be soft tissue healing and crestal marginal bone loss around implants.

Soft tissue healing will be assessed on the operative day, 2 weeks, and 4 weeks using Landry index. Crestal bone loss will be assessed using a standardized periapical x-ray at baseline and after 1 month with periapical x-ray.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adequate zone of keratinized mucosa.
  • Osseointegrated Implants ready for second-stage surgery.

Exclusion criteria

  • Heavy smokers due to increased risk of infection, delayed wound healing, and poor immune response.
  • Medically compromised patients due to affection of the peri-implant health and tissue maintenance.
  • Bad oral hygiene
  • Patients with an exposed cover screw
  • Evidence of bone loss in the preoperative peri-apical radiograph.

Treatment and study plan

Conventional surgery

Device

an implant will be exposed using the conventional surgical exposure techniques with a tissue punch, the cover screw will be removed, and the healing abutment placed

Diode laser 940 nm

Device

implant will be uncovered using a diode laser (940nm) in contact type with a continuous mode at a power of 1.5 watts, the laser tip will be used in a circular motion to create a small opening which will be increased till large enough to expose and remove the cover screw and place the healing abutments.

Electrosurgical

Device

the monopolar electrosurgical device will be used in the same way as the laser tip with additional care avoiding contacting the implants during exposure.

Primary outcomes

  1. Change in pain intensity

    Time frame: Baseline and after 1 week

    Pain intensity using a Visual Analogue Scale (VAS) score (0 to 10 cm), with a VAS marker of 0-2.50 cm for mild pain; 2.60-5.00 cm for moderate pain; 5.10-7.50 cm for severe pain; 7.60-10.0 cm for unbearable pain (11) during the operative day and the following 7 days.

  2. Change in soft tissue healing

    Time frame: after 1 and 2 weeks

    Soft tissue healing using the Landry index where the following 4 parameters: tissue color, response to palpation, granulation tissue, and incision margin will be assessed with a 5-level score (1= very poor to 5= Excellent). The healing index will be recorded at 2 and 4 weeks.

Secondary outcomes

  1. Change in creastal bone loss

    Time frame: Baseline and 1 month

    Crestal Bone loss following implant exposure using standardized periapical x-ray with implants platform as a reference, with the use of XCP dental x-ray film holder at baseline and after 1 month then the radiographic subtractive measure will be applied to measure the amount of marginal bone loss

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

The Effect of Diode Laser 940 Nm Versus Electrosurgical Device During Second Stage Implant Surgery on Bone and Soft Tissue Healing (A Randomized Controlled Clinical Trial)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Sep 24, 2024

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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