Pain Severity in Flapless Dental Implant Placement Using Laser

Jaw, Edentulous, Partially Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06294249
• Other study ID #: 20045125
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: December 4, 2023

Study information

• Verified date: March 2024
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 4, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Mouth, Edentulous
• Pain

Intervention

Device:
• Laser-induced Incision
On the treatment side, an incision was made on the crest of the alveolar soft tissue using the laser.

Procedure:
• Punch Incision
On the control side, a punch incision was made on the crest of the alveolar soft tissue using using a punch.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	shiraz University of medical sciences	Shiraz	Fars

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.