Pain Severity in Flapless Dental Implant Placement Using Laser

NCT06294249 | Completed Phase 4 DMC FDA Device

• 1 other identifier: 20045125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw, Edentulous, Partially

Keywords

Jaw, Edentulous, Partially; Pain Measurement; Laser Therapy; Dental Implants; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Laser-induced Incision

EXPERIMENTAL

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; Procedure: Implant Placement

Punch Incision

ACTIVE COMPARATOR

The soft tissue Osstem punch (South Korea) was used.

Procedure: Punch Incision; Procedure: Implant Placement

Interventions

Laser-induced Incision DEVICE

On the treatment side, an incision was made on the crest of the alveolar soft tissue using the laser.

Laser-induced Incision

Punch Incision PROCEDURE

On the control side, a punch incision was made on the crest of the alveolar soft tissue using using a punch.

Punch Incision

Implant Placement PROCEDURE

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.

Laser-induced Incision; Punch Incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult human subjects agreed to participate in the study and return on follow-up times
• Subjects eligible for receiving dental implants
• 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
• Subjects with sufficient keratinization tissue at the implant sites

You may not qualify if:

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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

shiraz University of medical sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• +98-9125850829 Tabrizi, DMD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: March 5, 2024
• Study Start: January 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 4, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

IR (1)