Pain Severity in Flapless Dental Implant Placement Using Laser

Phase 4

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: Laser-induced Incision; Procedure: Punch Incision; Procedure: Implant Placement

• Registration Number: NCT06294249
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-04
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-02-27
• Status Verified: 2024-03
• Study First Posted: 2024-03-05
• Last Update Submitted: 2024-03-23
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser-induced Incision	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.
Punch Incision	Implant Placement	The soft tissue Osstem punch (South Korea) was used.
Punch Incision	Punch Incision	The soft tissue Osstem punch (South Korea) was used.
Laser-induced Incision	Implant Placement	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

shiraz University of medical sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of