Periodontal InflammationNCT06140394
The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy in Different Age Groups
A study testing diode laser and non surgical scaling in people with Periodontal Inflammation, run by Faculty of Dental Medicine for Girls at 2 sites in Egypt.
Trial summary
the summary is to evaluate The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation
- What is being tested?
- diode laser and non surgical scaling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesEgypt
- Study dates
- 29 Apr 2023to 25 Jun 2024
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males and females
- aged below 40 or above 60
- periodontitis stage 2
- no tooth loss due to periodontitis
Who cannot join
- smoking habits
- history of antibiotics
- history of systemic diseases
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Al-Azhar University
Cairo, Nasrcity Nasr Street, 11765
Hamdy Nassar
Cairo
About this study
Official title: The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients (A Randomized Clinical Trial)
the summary is to evaluate The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients
Read the detailed description
2 ml of unstimulated saliva will be collected using spitting method, the collected samples will then be analyzed using Elisa technique for salivary Inducible nitrous oxide synthase levels.
- Conditions
- Periodontal Inflammation
- Being tested
- diode laser, non surgical scaling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laserOther
low level diode therapy
non surgical scalingOther
non surgical scaling using ultrasonic
| Study group | Role | What they receive |
|---|---|---|
| old age group | Active comparator | old age group above 60 years old Receives: Other: diode laser; Other: non surgical scaling |
| young aged group | Placebo comparator | young age group below 40 years old Receives: Other: diode laser; Other: non surgical scaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical parameters (gingival index)
measurement if the gingival index using scoring system. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Measured: 6 months
clinical parameters (clinical attachment loss)
measurement of clinical parameters clinical attachment loss in millimeters
Measured: 6 months
Secondary outcomes (1)
assessment of inducible nitrous oxide synthase levels
measurement of inducible nitrous oxide synthase levels in different age groups before the procedure and after using Elisa kit.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start29 Apr 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alaa Allah Hesham, Faculty of Dental Medicine for Girls
- Investigators
- Alaa H hesham mosa, bachelor's, Study chair, Faculty of Dental Medicine for Girlshamdy H nassar, Principal investigator, Faculty of Dental Medicine for Girlsamal AA ali, Study director, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140394
- Sponsor's protocol ID
- P-ME-23-04
- Status last verified
- Jun 2024
- First submitted
- 12 Nov 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06140394
- Acronym / sponsor ID
- P-ME-23-04
- Conditions
- Periodontal Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 20 Nov 2023 (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 summary is to evaluate The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients
Detailed description
2 ml of unstimulated saliva will be collected using spitting method, the collected samples will then be analyzed using Elisa technique for salivary Inducible nitrous oxide synthase levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| old age group | Active comparator | Other: diode laser, Other: non surgical scalingold age group above 60 years old |
| young aged group | Placebo comparator | Other: diode laser, Other: non surgical scalingyoung age group below 40 years old |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- males and females
- aged below 40 or above 60
- periodontitis stage 2
- no tooth loss due to periodontitis
Key exclusion criteria (3 listed)
- smoking habits
- history of antibiotics
- history of systemic diseases
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 laserlow level diode therapy | Other | old age group, young aged group |
| non surgical scalingnon surgical scaling using ultrasonic | Other | old age group, young aged group |
Primary outcome
clinical parameters (gingival index)
Time frame: 6 months
measurement if the gingival index using scoring system. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
clinical parameters (clinical attachment loss)
Time frame: 6 months
measurement of clinical parameters clinical attachment loss in millimeters
1 secondary outcome
assessment of inducible nitrous oxide synthase levels
Time frame: 3 months
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 28 Jun 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.
Alaa H hesham mosa, bachelor's study chair
Faculty of Dental Medicine for Girls
hamdy H nassar principal investigator
Faculty of Dental Medicine for Girls
amal AA ali study director
Faculty of Dental Medicine for Girls
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diode laser and non surgical scaling in people with Periodontal Inflammation, run by Faculty of Dental Medicine for Girls at 2 sites in Egypt.
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 3 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 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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. Some participants in this study may receive a placebo. 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?
clinical parameters (gingival index) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 28 Jun 2024.