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

Not Applicable

Recruiting

• Conditions: Dental Implant; Bone Healing; Soft Tissue Healing
• Interventions: Device: Electrosurgical; Device: Conventional surgery; Device: Diode laser 940 nm

• Registration Number: NCT06231134
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrosuregry	Electrosurgical	-
Conventional surgery	Conventional surgery	-
Dioad laser	Diode laser 940 nm	-

Primary Outcome Measures

Name	Time	Method
Change in pain intensity	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.
Change in soft tissue healing	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 Outcome Measures

Name	Time	Method
Change in creastal bone loss	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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt