Periodontal DiseaseNCT06677736
Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: a Relation to Periodontal Inflammaging
A study testing conventional scaling and debridement and Diode laser as adjunctive to conventional scaling and debridement in people with Periodontal Disease, run by Rawda Saleh Saad Alashmawy at 1 site in Egypt.
Trial summary
Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- conventional scaling and debridement and Diode laser as adjunctive to conventional scaling and debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2023to 12 Oct 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Aged below 40 or above 60.
- Have at least 16 natural teeth excluding wisdom.
- Provide informed consent and willingness to cooperate with study protocol.
- Periodontitis stage II patients (23):
- CAL from 3-4 mm.
Show all 9Show fewer
- Radiographic bone loss (15% to 33%).
- No tooth loss due to periodontitis.
- Maximum probing depth ≤ 5 mm, mostly horizontal bone loss
Who cannot join
- 1- Patients with any smoking habits 2- History of antibiotics in the previous three months. 3- Pregnant or lactating female. 4- Treatment with any systemic drug. 5- History of systemic disease. 6- Patients who received periodontal treatment in the last 6 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Misr university for science and technology
Giza, Giza Governorate, 3220001
About this study
Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging
Read the detailed description
Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging
- Conditions
- Periodontal Disease
- Being tested
- conventional scaling and debridement, Diode laser as adjunctive to conventional scaling and debridement
- Keywords
- inflamaging
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional scaling and debridementProcedure or surgery
conventional scaling and debridement
Diode laser as adjunctive to conventional scaling and debridementRadiation
Diode laser as adjunctive to conventional scaling and debridement
| Study group | Role | What they receive |
|---|---|---|
| conventional scaling and debridement young age patient | Experimental | conventional scaling and debridement young age patient Receives: Procedure: conventional scaling and debridement |
| conventional scaling and debridement old age patient | Experimental | conventional scaling and debridement old age patient Receives: Procedure: conventional scaling and debridement |
| diode laser as adjunctive to scaling and debridement young age patient | Experimental | diode laser as adjunctive to scaling and debridement young age patient Receives: Radiation: Diode laser as adjunctive to conventional scaling and debridement |
| diode laser as adjunctive to scaling and debridement old age patient | Experimental | diode laser as adjunctive to scaling and debridement old age patient Receives: Radiation: Diode laser as adjunctive to conventional scaling and debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment loss
Measured: Base line , follow up after 1 month , second follow up after 6 months
Gingival index
Measured: base line, follow up after 1 month, second follow up after 6 months
Toll like receptor - 4
Measured: base line, follow up after 1 month, second follow up after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start12 Jul 2023
- Primary completion12 Mar 2024
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawda Saleh Saad Alashmawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rawda Saleh Saad Alashmawy, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677736
- Sponsor's protocol ID
- 2022\0083
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: a Relation to Periodontal Inflammaging
- ClinicalTrials.gov ID
- NCT06677736
- Acronym / sponsor ID
- 2022\0083
- Conditions
- Periodontal Disease
- Keywords
- inflamaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rawda Saleh Saad AlashmawyUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 7 Nov 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.
Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging
Detailed description
Effect of Low-Level Laser Therapy on Salivary Toll Like Receptor- 4 Concentration of Periodontitis Patients: A Relation to Periodontal Inflammaging
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| conventional scaling and debridement young age patient | Experimental | Procedure: conventional scaling and debridementconventional scaling and debridement young age patient |
| conventional scaling and debridement old age patient | Experimental | Procedure: conventional scaling and debridementconventional scaling and debridement old age patient |
| diode laser as adjunctive to scaling and debridement young age patient | Experimental | Radiation: Diode laser as adjunctive to conventional scaling and debridementdiode laser as adjunctive to scaling and debridement young age patient |
| diode laser as adjunctive to scaling and debridement old age patient | Experimental | Radiation: Diode laser as adjunctive to conventional scaling and debridementdiode laser as adjunctive to scaling and debridement old age patient |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female
- Aged below 40 or above 60.
- Have at least 16 natural teeth excluding wisdom.
- Provide informed consent and willingness to cooperate with study protocol.
- Periodontitis stage II patients (23):
Key exclusion criteria (1 listed)
- 1- Patients with any smoking habits 2- History of antibiotics in the previous three months. 3- Pregnant or lactating female. 4- Treatment with any systemic drug. 5- History of systemic disease. 6- Patients who received periodontal treatment in 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 |
|---|---|---|
| conventional scaling and debridementconventional scaling and debridement | Procedure or surgery | conventional scaling and debridement old age patient, conventional scaling and debridement young age patient |
| Diode laser as adjunctive to conventional scaling and debridementDiode laser as adjunctive to conventional scaling and debridement | Radiation | diode laser as adjunctive to scaling and debridement old age patient, diode laser as adjunctive to scaling and debridement young age patient |
Primary outcome
Clinical attachment loss
Time frame: Base line , follow up after 1 month , second follow up after 6 months
Gingival index
Time frame: base line, follow up after 1 month, second follow up after 6 months
Toll like receptor - 4
Time frame: base line, follow up after 1 month, second follow up after 6 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 7 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 conventional scaling and debridement and Diode laser as adjunctive to conventional scaling and debridement in people with Periodontal Disease, run by Rawda Saleh Saad Alashmawy at 1 site 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 9 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 7 Nov 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 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. 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 attachment loss (time frame: Base line , follow up after 1 month , second follow up after 6 months). The study lists 3 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 7 Nov 2024.