PeriodontitisNCT03716154
Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
A study testing Diode laser in people with Periodontitis, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
a randomized controlled single-blinded study. the hypothesis of this clinical trial is that disjunctive use of diode laser improve the clinical parameters of periodontists , and there are significant difference between the conventional treatment and diode laser as an adjunct Read more about this study
- Who is it for?
- Ages 28 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Diode laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteJordan
- Study dates
- 1 Apr 2017to 30 Apr 2018
- 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 28 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients having periodontitis in at least two quadrants each quadrant should have at least 4 sites with PD >4mm.
- Both male and female patients.
- Patient who are ready to cooperate with diode laser treatment.
- Patient who can comply with 3 visits for follow up (three times).
Who cannot join
- Subjects with systemic diseases that may interfere with wound healing (such as diabetes) or any systemic disease that complicates the treatment.
- Pregnant women and breast feeding.
- Smokers, alcohol or drug dependent.
- Patients who received any form of periodontal treatment within the last 6 months.
- Patients who are currently taking or were on antibiotic treatment within the last 6 months.
- Presence of faulty restoration at teeth involved in the disease.
- Teeth indicated for extraction at sites that will be part of the study.
- Patient under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
a randomized controlled single-blinded study. the hypothesis of this clinical trial is that disjunctive use of diode laser improve the clinical parameters of periodontists , and there are significant difference between the conventional treatment and diode laser as an adjunct
Read the detailed description
A total of 240 sites with deep pocket in 30 systemically healthy patients with chronic periodontitis, from subjects attending Jordan University of Science and Technology (JUST) Postgraduate Dental Clinic (PDC), the age range were (28-55) year, between Apr 2017 and Oct 2017. Those patients were enrolled in a randomized controlled single-blinded study. For each patient, full medical and dental history and periodontal examination were recorded. Clinical parameters such as pocket depth (PD), clinical attachment loss (CAL), gingival index (GI) and plaque index (PI) were evaluated at the baseline. All Patients underwent initial periodontal therapy; SRP which was performed using a sonic device and hand instruments and the sites were divided randomly into two groups SRP alone and SRP with adjunctive diode 810 nm laser in the contralateral sites in the same jaw. The Clinical parameters have been re-evaluated at 1, 3 and 6 months to test the effectiveness of (810 nm, 2 W, pulsed mode, for 20 sec) in treatment of CP. Diode laser therapy was applied to periodontal pockets in the same day of treatment.
- Conditions
- Periodontitis
- Being tested
- Diode laser
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserRadiation
Diode laser 810nm, 2W, 20sec, 20 HZ
| Study group | Role | What they receive |
|---|---|---|
| SRP and diode laser | Experimental | In a split mouth design either left or right sites randomly treated by SRP and diode laser as an adjunct Receives: Radiation: Diode laser |
| SRP alone | No intervention | The other sites in the other side will be treated by SRP alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth (PD) in millimeter (mm), clinical attachment loss (CAL) in millimeter (mm)
PD its the distance from gingival margin to the base of the pocket in millimeter (mm) CAL the recession is added to the PD in millimeter (mm)
Measured: Change from baseline to 1 month in PD and CAL, change from baseline to 3 month in PD and CAL ,change from baseline to 6 month in PD and CAL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Apr 2017
- Primary completion1 Dec 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- rola A alhabashneh, prof, Study director, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716154
- Sponsor's protocol ID
- JUSTShbool1
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT03716154
- Acronym / sponsor ID
- JUSTShbool1
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 23 Oct 2018 (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.
a randomized controlled single-blinded study. the hypothesis of this clinical trial is that disjunctive use of diode laser improve the clinical parameters of periodontists , and there are significant difference between the conventional treatment and diode laser as an adjunct
Detailed description
A total of 240 sites with deep pocket in 30 systemically healthy patients with chronic periodontitis, from subjects attending Jordan University of Science and Technology (JUST) Postgraduate Dental Clinic (PDC), the age range were (28-55) year, between Apr 2017 and Oct 2017. Those patients were enrolled in a randomized controlled single-blinded study. For each patient, full medical and dental history and periodontal examination were recorded. Clinical parameters such as pocket depth (PD), clinical attachment loss (CAL), gingival index (GI) and plaque index (PI) were evaluated at the baseline. All Patients underwent initial periodontal therapy; SRP which was performed using a sonic device and hand instruments and the sites were divided randomly into two groups SRP alone and SRP with adjunctive diode 810 nm laser in the contralateral sites in the same jaw. The Clinical parameters have been re-evaluated at 1, 3 and 6 months to test the effectiveness of (810 nm, 2 W, pulsed mode, for 20 sec) in treatment of CP. Diode laser therapy was applied to periodontal pockets in the same day of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- split mouth
| Arm | Type | Receives |
|---|---|---|
| SRP and diode laser | Experimental | Radiation: Diode laserIn a split mouth design either left or right sites randomly treated by SRP and diode laser as an adjunct |
| SRP alone | No intervention | –The other sites in the other side will be treated by SRP alone |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy patients having periodontitis in at least two quadrants each quadrant should have at least 4 sites with PD >4mm.
- Both male and female patients.
- Patient who are ready to cooperate with diode laser treatment.
- Patient who can comply with 3 visits for follow up (three times).
Key exclusion criteria (8 listed)
- Subjects with systemic diseases that may interfere with wound healing (such as diabetes) or any systemic disease that complicates the treatment.
- Pregnant women and breast feeding.
- Smokers, alcohol or drug dependent.
- Patients who received any form of periodontal treatment within the last 6 months.
- Patients who are currently taking or were on antibiotic treatment within the last 6 months.
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 laserDiode laser 810nm, 2W, 20sec, 20 HZ | Radiation | SRP and diode laser |
Primary outcome
Probing depth (PD) in millimeter (mm), clinical attachment loss (CAL) in millimeter (mm)
Time frame: Change from baseline to 1 month in PD and CAL, change from baseline to 3 month in PD and CAL ,change from baseline to 6 month in PD and CAL
PD its the distance from gingival margin to the base of the pocket in millimeter (mm) CAL the recession is added to the PD in millimeter (mm)
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 23 Oct 2018.
- Individual participant dataSharing planned: No
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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.
rola A alhabashneh, prof study director
Jordan University of Science and Technology
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 in people with Periodontitis, run by Jordan University of Science and Technology at 1 site in Jordan.
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 8 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 23 Oct 2018. 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 Jordan. 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?
Probing depth (PD) in millimeter (mm), clinical attachment loss (CAL) in millimeter (mm) (time frame: Change from baseline to 1 month in PD and CAL, change from baseline to 3 month in PD and CAL ,change from baseline to 6 month in PD and CAL). 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 23 Oct 2018.