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

NCT ID: NCT06231134

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-01-30

Brief Summary

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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

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Conditions

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Dental Implant Bone Healing Soft Tissue Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional surgery

Group Type ACTIVE_COMPARATOR

Conventional surgery

Intervention Type 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

Dioad laser

Group Type EXPERIMENTAL

Diode laser 940 nm

Intervention Type 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.

Electrosuregry

Group Type EXPERIMENTAL

Electrosurgical

Intervention Type 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.

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0801-11/2023

Identifier Type: -

Identifier Source: org_study_id

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