Dental Implant Exposure Using Diode LaserNCT06213467
Using Diode Laser in 2nd Stage of Implant.
A study testing diode laser 940nm in people with Dental Implant Exposure Using Diode Laser, run by University of Baghdad at 1 site in Iraq.
Trial summary
Dental Implants that are teeth replacements usually place with two stages. In the second stage the implant fixture, (which is the body that inserted in the bone is exposed to place the artificial tooth), is exposed using surgical blade, however; an alternative method using diode laser may be used. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Implant Exposure Using Diode Laser
- What is being tested?
- diode laser 940nm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIraq
- Study dates
- 21 Nov 2022to 30 Nov 2023
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Describe the target population and the criteria for their inclusion. Patients indicated for fixed implant treatment with conventional Implant procedure with implant insertd before (3-6) months by using two stage dental implant.
- 2. Treatment with two or more implant in same patient. 3. Patients aged from 18 to 70 years of both the gender with the presence of adequate osseointegration and healthy keratinized tissue surrounding the implant site.
Who cannot join
- 1. Patient have single implant. 2. Expose dental implant or already have gingival former. 3. Poor oral hygiene. 4. Failure implant osseointegration to bone.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
laser institute for postgraduate studies, University of Baghdad
Baghdad, Al-Jadiriya, 10071
About this study
Official title: Pain Perception and Evaluated Injectable Anesthesia Needed by Using Pulsating Diode Laser 940nm in Second Stage Implant Exposure Versus Traditional Methods
Dental Implants that are teeth replacements usually place with two stages. In the second stage the implant fixture, (which is the body that inserted in the bone is exposed to place the artificial tooth), is exposed using surgical blade, however; an alternative method using diode laser may be used. This study aimed to compare the two methods in relation to pain anticipated by the patients and the need for local anesthesia usage.
Read the detailed description
Second-stage implant exposure involves removing soft tissue above the dental implant, as a part of the implant procedures to replace the missing teeth which can be done either by using diode laser or traditional method This study included fifteen patients, aged between 18 and 70 years old. Implant exposure was performed on 15 patients has at least two implants in two groups: group 1 with a diode laser at 940nm and group 2 with the traditional method performed either using a puncture, flap, or incision in 5 private clinics and one governmental run hospital in city of Baghdad/ Iraq.
- Being tested
- diode laser 940nm
- Keywords
- diode laser, dental implant, local anasthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laser 940nmDevice
Exposure for the two implants was done at the same visit, with one implant being exposed using diode laser and the other implant using traditional method
| Study group | Role | What they receive |
|---|---|---|
| A and B | Experimental | Each patient in which two implants have already been inserted are exposed, the first implant expose by using traditional methods , the second one expose by using diode laser 940nm . Receives: Device: diode laser 940nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perceived by the patient.
Pain was measured using visual analogue scale from 0-10, filled by the patient
Measured: recordings were done immediately at time of exposure , after 2 , 5 ,7 days postsurgical.
Secondary outcomes (1)
need for injectable anesthesia
need for anesthesia done when patient feels pain after application of local anesthesia
Measured: at time of operation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start21 Nov 2022
- Primary completion16 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant Exposure Using Diode LaserStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 15 patients that have at least two dental implants in jaws.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad Mahmood Jameel, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213467
- Sponsor's protocol ID
- 1375
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be provided when needed
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception and Evaluated Injectable Anesthesia Needed by Using Pulsating Diode Laser 940nm in Second Stage Implant Exposure Versus Traditional Methods
- ClinicalTrials.gov ID
- NCT06213467
- Acronym / sponsor ID
- 1375
- Keywords
- diode laser, dental implant, local anasthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 Jan 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.
Dental Implants that are teeth replacements usually place with two stages. In the second stage the implant fixture, (which is the body that inserted in the bone is exposed to place the artificial tooth), is exposed using surgical blade, however; an alternative method using diode laser may be used. This study aimed to compare the two methods in relation to pain anticipated by the patients and the need for local anesthesia usage.
Detailed description
Second-stage implant exposure involves removing soft tissue above the dental implant, as a part of the implant procedures to replace the missing teeth which can be done either by using diode laser or traditional method This study included fifteen patients, aged between 18 and 70 years old. Implant exposure was performed on 15 patients has at least two implants in two groups: group 1 with a diode laser at 940nm and group 2 with the traditional method performed either using a puncture, flap, or incision in 5 private clinics and one governmental run hospital in city of Baghdad/ Iraq.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 patients that have at least two dental implants in jaws.
| Arm | Type | Receives |
|---|---|---|
| A and B | Experimental | Device: diode laser 940nmEach patient in which two implants have already been inserted are exposed, the first implant expose by using traditional methods , the second one expose by using diode laser 940nm . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Describe the target population and the criteria for their inclusion. Patients indicated for fixed implant treatment with conventional Implant procedure with implant insertd before (3-6) months by using two stage dental implant.
- 2. Treatment with two or more implant in same patient. 3. Patients aged from 18 to 70 years of both the gender with the presence of adequate osseointegration and healthy keratinized tissue surrounding the implant site.
Key exclusion criteria (1 listed)
- 1. Patient have single implant. 2. Expose dental implant or already have gingival former. 3. Poor oral hygiene. 4. Failure implant osseointegration to bone.
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 |
|---|---|---|
| diode laser 940nmExposure for the two implants was done at the same visit, with one implant being exposed using diode laser and the other implant using traditional method | Device | A and B |
Primary outcome
Pain perceived by the patient.
Time frame: recordings were done immediately at time of exposure , after 2 , 5 ,7 days postsurgical.
Pain was measured using visual analogue scale from 0-10, filled by the patient
1 secondary outcome
need for injectable anesthesia
Time frame: at time of operation treatment
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 19 Jan 2024.
- Individual participant dataSharing planned: No. will be provided when needed
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diode laser 940nm in people with Dental Implant Exposure Using Diode Laser, run by University of Baghdad at 1 site in Iraq.
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 2 inclusion and 1 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 19 Jan 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 Iraq. 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.
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 perceived by the patient. (time frame: recordings were done immediately at time of exposure , after 2 , 5 ,7 days postsurgical.). 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 19 Jan 2024.