Pain Severity in Flapless Dental Implant Placement Using Laser

The Evaluation of Pain Severity in Flapless Dental Implant Placement Using Laser-induced Incisions: A Split Mouth Randomized Clinical Trial Study

The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser.

Study Overview

• Status: Completed
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: Laser-induced Incision; Procedure: Implant Placement; Procedure: Punch Incision

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adult human subjects agreed to participate in the study and return on follow-up times
2. Subjects eligible for receiving dental implants
3. Subjects with an edentulous area in the posterior of the mandible bilaterally 3- Subjects with sufficient bone width and height (>5 mm width, and >10 mm height) at the implant sites
4. Subjects with sufficient keratinization tissue at the implant sites

Exclusion Criteria:

1. Subjects refused to return for follow-up or refused study enrollment.
2. Subjects with uncontrolled systemic diseases
3. Subjects younger than 18 years
4. Subjects receiving psychotropic drugs

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser-induced Incision; The Biolase Epic 10 diode laser device (Biolase, USA) with 940 nm wavelength, 10 W of max output power, 20 KHz of pulse repetition rate, and continuous pulse mode was used.	Device: Laser-induced Incision; On the treatment side, an incision was made on the crest of the alveolar soft tissue using the laser.; Procedure: Implant Placement; Implant placement was done in both laser and punch arms. The drilling was performed based on the company (Straumman) protocol. On each side, a dental implant (Straumman SP, Basel, Switzerland) and healing abutment were placed. Patients were visited at 24, 48, 72 hours, and 7 days after insertion.
Active Comparator: Punch Incision; The soft tissue Osstem punch (South Korea) was used.	Procedure: Implant Placement; Implant placement was done in both laser and punch arms. The drilling was performed based on the company (Straumman) protocol. On each side, a dental implant (Straumman SP, Basel, Switzerland) and healing abutment were placed. Patients were visited at 24, 48, 72 hours, and 7 days after insertion.; Procedure: Punch Incision; On the control side, a punch incision was made on the crest of the alveolar soft tissue using using a punch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	Measured using the visual analogue scale (VAS): 0-3 mild pain, 4-6 moderate pain, and 7-10 sever pain.	Patients were visited at 24, 48, 72 hours, and 7 days after insertion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dehiscence	The dehiscence was documented in visiting sessions. The flap dehiscence was diagnosed visually by the clinician.	Patients were visited at 24, 48, 72 hours, and 7 days after insertion.
Infection	The signs and symptoms of infection were documented. The Infection was diagnosed visually by clinician when the soft tissue redness and pus discharge along with reported pain by the patient is present.	Patients were visited at 24, 48, 72 hours, and 7 days after insertion.

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Collaborators: Shahid Beheshti University of Medical Sciences
• Investigators: Principal Investigator: +98-9125850829 Tabrizi, DMD, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Dental Implants; Laser Therapy; Pain Measurement; Jaw, Edentulous, Partially
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Pain; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: 20045125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No