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

January 29, 2024 updated by: Hams Hamed Abdelrahman

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Yasmine Hafez, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional surgery
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
Experimental: Dioad laser
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.
Experimental: Electrosuregry
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity
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.
Baseline and after 1 week
Change in soft tissue healing
Time Frame: after 2 and 4 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.
after 2 and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in creastal bone loss
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
Baseline and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 0801-11/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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