Pain Severity in Flapless Dental Implant Placement Using Laser

NCT ID: NCT06294249

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-04

Brief Summary

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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

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Laser-induced Incision

Intervention Type DEVICE

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

Implant Placement

Intervention Type 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.

Punch Incision

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

Group Type ACTIVE_COMPARATOR

Punch Incision

Intervention Type PROCEDURE

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

Implant Placement

Intervention Type 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.

Interventions

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Laser-induced Incision

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

Intervention Type DEVICE

Punch Incision

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Reza Tabrizi, DMD

Associate Professor of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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+98-9125850829 Tabrizi, DMD

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Locations

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shiraz University of medical sciences

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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20045125

Identifier Type: -

Identifier Source: org_study_id

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