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

Dental Implant Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231134
• Other study ID #: 0801-11/2023
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: Yasmine Hafez, BDS
• Phone: 01005236758
• Email: yasmine.alaaeldine.dent[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant
• Soft Tissue Healing

Intervention

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

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity	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.	Baseline and after 1 week
Primary	Change in soft tissue healing	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.	after 2 and 4 weeks
Secondary	Change in creastal bone loss	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	Baseline and 1 month