Clinical trial NCT06231134: Diode Laser 940 Nm Versus Electrosurgical Device During Second Stage Implant Surgery on Bone and Soft Tissue Healing
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Bone Healing
Soft Tissue Healing
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 33
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain intensity
timeFrame: Baseline and after 1 week
measure: Change in soft tissue healing
timeFrame: after 1 and 2 weeks
Secondary outcomes:
measure: Change in creastal bone loss
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References: