Using Diode Laser in 2nd Stage of Implant.

Pain Perception and Evaluated Injectable Anesthesia Needed by Using Pulsating Diode Laser 940nm in Second Stage Implant Exposure Versus Traditional Methods

Dental Implants that are teeth replacements usually place with two stages. In the second stage the implant fixture, (which is the body that inserted in the bone is exposed to place the artificial tooth), is exposed using surgical blade, however; an alternative method using diode laser may be used. This study aimed to compare the two methods in relation to pain anticipated by the patients and the need for local anesthesia usage.

Study Overview

• Status: Completed
• Conditions: Dental Implant Exposure Using Diode Laser
• Intervention / Treatment: Device: diode laser 940nm

Detailed Description

Second-stage implant exposure involves removing soft tissue above the dental implant, as a part of the implant procedures to replace the missing teeth which can be done either by using diode laser or traditional method This study included fifteen patients, aged between 18 and 70 years old. Implant exposure was performed on 15 patients has at least two implants in two groups: group 1 with a diode laser at 940nm and group 2 with the traditional method performed either using a puncture, flap, or incision in 5 private clinics and one governmental run hospital in city of Baghdad/ Iraq.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Al-Jadiriya
    • Baghdad, Al-Jadiriya, Iraq, 10071
      • laser institute for postgraduate studies, University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 1. Describe the target population and the criteria for their inclusion. Patients indicated for fixed implant treatment with conventional Implant procedure with implant insertd before (3-6) months by using two stage dental implant.

2. Treatment with two or more implant in same patient. 3. Patients aged from 18 to 70 years of both the gender with the presence of adequate osseointegration and healthy keratinized tissue surrounding the implant site.

Exclusion Criteria:

• 1. Patient have single implant. 2. Expose dental implant or already have gingival former. 3. Poor oral hygiene. 4. Failure implant osseointegration to bone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A and B; Each patient in which two implants have already been inserted are exposed, the first implant expose by using traditional methods , the second one expose by using diode laser 940nm .	Device: diode laser 940nm; Exposure for the two implants was done at the same visit, with one implant being exposed using diode laser and the other implant using traditional method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perceived by the patient.	Pain was measured using visual analogue scale from 0-10, filled by the patient	recordings were done immediately at time of exposure , after 2 , 5 ,7 days postsurgical.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for injectable anesthesia	need for anesthesia done when patient feels pain after application of local anesthesia	at time of operation treatment

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: dental implant; diode laser; local anasthesia
• Other Study ID Numbers: 1375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will be provided when needed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No