Alexandria Faculty of Dentistry
Alexandria, Egypt
NCT Number: NCT06231134
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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Notify Me25 year and older
All sexes
Interventional
Not applicable
Alexandria, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
the monopolar electrosurgical device will be used in the same way as the laser tip with additional care avoiding contacting the implants during exposure.
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.
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.
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
Hams Hamed Abdelrahman
Other
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)
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