Jaw, Edentulous, PartiallyPhase 4NCT06294249
Pain Severity in Flapless Dental Implant Placement Using Laser
A Phase 4 study testing Laser-induced Incision, Punch Incision and Implant Placement in people with Jaw, Edentulous, Partially, run by Shiraz University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Laser-induced Incision, Punch Incision and Implant Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2020to 4 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Pain Severity in Flapless Dental Implant Placement Using Laser-induced Incisions: A Split Mouth Randomized Clinical Trial Study
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
- Being tested
- Laser-induced Incision, Punch Incision, Implant Placement
- Keywords
- Jaw, Edentulous, Partially, Pain Measurement, Laser Therapy, Dental Implants, Randomized Controlled Trial
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-induced IncisionDevice
On the treatment side, an incision was made on the crest of the alveolar soft tissue using the laser.
Punch IncisionProcedure or surgery
On the control side, a punch incision was made on the crest of the alveolar soft tissue using using a punch.
Implant PlacementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laser-induced Incision; Procedure: Implant Placement |
| Punch Incision | Active comparator | The soft tissue Osstem punch (South Korea) was used. Receives: Procedure: Punch Incision; Procedure: Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Measured using the visual analogue scale (VAS): 0-3 mild pain, 4-6 moderate pain, and 7-10 sever pain.
Measured: Patients were visited at 24, 48, 72 hours, and 7 days after insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jan 2020
- Primary completion1 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Reza Tabrizi, DMD, Shiraz University of Medical Sciences
- Investigators
- +98-9125850829 Tabrizi, DMD, Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294249
- Sponsor's protocol ID
- 20045125
- Status last verified
- Mar 2024
- First submitted
- 22 Jan 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Pain Severity in Flapless Dental Implant Placement Using Laser-induced Incisions: A Split Mouth Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06294249
- Acronym / sponsor ID
- 20045125
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- Jaw, Edentulous, Partially, Pain Measurement, Laser Therapy, Dental Implants, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser-induced Incision | Experimental | Device: Laser-induced Incision, Procedure: Implant PlacementThe 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 | Active comparator | Procedure: Punch Incision, Procedure: Implant PlacementThe soft tissue Osstem punch (South Korea) was used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser-induced IncisionOn the treatment side, an incision was made on the crest of the alveolar soft tissue using the laser. | Device | Laser-induced Incision |
| Punch IncisionOn the control side, a punch incision was made on the crest of the alveolar soft tissue using using a punch. | Procedure or surgery | Punch Incision |
| Implant PlacementImplant 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. | Procedure or surgery | Laser-induced Incision, Punch Incision |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
+98-9125850829 Tabrizi, DMD principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laser-induced Incision, Punch Incision and Implant Placement in people with Jaw, Edentulous, Partially, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: Patients were visited at 24, 48, 72 hours, and 7 days after insertion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.