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Completed

NCT Number: NCT06294249

Pain Severity in Flapless Dental Implant Placement Using Laser

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

shiraz University of medical sciences

Shiraz, Fars, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Laser-induced Incision

Device

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

Punch Incision

Procedure

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

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.

Primary outcomes

  1. Pain Severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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