Diode Laser TherapyNCT07056257
Adjunct Use of Diode Laser Therapy and Omega 3 Gel in Local Drug Delivery Approach on The Treatment of Localized Aggressive Periodontitis
A study testing Scaling-root planning (SRP), Scaling-root planning (SRP)+ laser therapy and Scaling-root planning (SRP)+ omega 3 gel in people with Diode Laser Therapy and Omega 3, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the effect of combination therapy between diode laser and omega3 gel in the local drug delivery approach as an adjunct to scaling and root planning on the management of localized aggressive periodontitis clinically and immunologically. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Diode Laser Therapy, Omega 3, Localized Aggressive Periodontitis
- What is being tested?
- Scaling-root planning (SRP), Scaling-root planning (SRP)+ laser therapy and Scaling-root planning (SRP)+ omega 3 gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 8 May 2022to 7 Mar 2025
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with localized aggressive periodontitis.
- Patients must be medically free.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude to maintain oral hygiene.
- Patients who are willing to participate in this study can enroll and complete it.
Who cannot join
- Patients with generalized aggressive periodontitis. Patients are over 35 years old.
- Pregnancy.
- Patients had scaling and root planning or antibiotic therapy in the last 6 months.
- Patients with hypersensitivity to fish oil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adjunct Use of Diode Laser Therapy and Omega 3 Gel in Local Drug Delivery Approach on The Treatment of Localized Aggressive Periodontitis
This study aims to evaluate and compare the effect of combination therapy between diode laser and omega3 gel in the local drug delivery approach as an adjunct to scaling and root planning on the management of localized aggressive periodontitis clinically and immunologically.
Read the detailed description
Periodontitis is a disease of the periodontium occurring in an otherwise healthy adolescent, which is characterized by a rapid loss of alveolar bone about more than one tooth of the permanent dentition.
The laser approach is an efficient and atraumatic technique to enhance its use for periodontal treatment. Within the limits of scientific data, treatment with diode laser and SRP showed a higher effect than SRP or laser alone.
Omega3 Polyunsaturated fatty acids (PUFA) have well recognized anti-inflammatory properties. They decrease inflammation through multiple pathways.
- Being tested
- Scaling-root planning (SRP), Scaling-root planning (SRP)+ laser therapy, Scaling-root planning (SRP)+ omega 3 gel, Scaling-root planning (SRP)+ laser therapy+ omega 3 gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling-root planning (SRP)Procedure or surgery
Thirteen sites [scaling-root planning (SRP)] were used as a control group.
Scaling-root planning (SRP)+ laser therapyProcedure or surgery
Thirteen sites [scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month].
Scaling-root planning (SRP)+ omega 3 gelProcedure or surgery
Thirteen sites [scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month].
Scaling-root planning (SRP)+ laser therapy+ omega 3 gelProcedure or surgery
Thirteen sites [combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month].
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Thirteen sites [scaling-root planning (SRP)] were used as a control group. Receives: Procedure: Scaling-root planning (SRP) |
| Group II | Experimental | Thirteen sites [scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month]. Receives: Procedure: Scaling-root planning (SRP)+ laser therapy |
| Group III | Experimental | Thirteen sites [scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month]. Receives: Procedure: Scaling-root planning (SRP)+ omega 3 gel |
| Group IV | Experimental | Thirteen sites [combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month]. Receives: Procedure: Scaling-root planning (SRP)+ laser therapy+ omega 3 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth
Probing pocket depth (PD) was recorded according to Ramfijord 1967.
Measured: 6 months post-procedure
Secondary outcomes (3)
Plaque score
Plaque score was recorded according to Silness and loe 1964.
Measured: 6 months post-procedure
Bleeding on probing
Bleeding on probing (BOP) according to Ainamo and Bay 1975.
Measured: 6 months post-procedure
Clinical attachment level loss
Clinical attachment level loss (CAL) according to according to Ramfijord 1967.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start8 May 2022
- Primary completion21 Apr 2024
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diode Laser TherapyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohammed Elsayed Ghannam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056257
- Sponsor's protocol ID
- R-OMPDR-4-22-11
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adjunct Use of Diode Laser Therapy and Omega 3 Gel in Local Drug Delivery Approach on The Treatment of Localized Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT07056257
- Acronym / sponsor ID
- R-OMPDR-4-22-11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 9 Jul 2025 (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.
This study aims to evaluate and compare the effect of combination therapy between diode laser and omega3 gel in the local drug delivery approach as an adjunct to scaling and root planning on the management of localized aggressive periodontitis clinically and immunologically.
Detailed description
Periodontitis is a disease of the periodontium occurring in an otherwise healthy adolescent, which is characterized by a rapid loss of alveolar bone about more than one tooth of the permanent dentition.
The laser approach is an efficient and atraumatic technique to enhance its use for periodontal treatment. Within the limits of scientific data, treatment with diode laser and SRP showed a higher effect than SRP or laser alone.
Omega3 Polyunsaturated fatty acids (PUFA) have well recognized anti-inflammatory properties. They decrease inflammation through multiple pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Scaling-root planning (SRP)Thirteen sites [scaling-root planning (SRP)] were used as a control group. |
| Group II | Experimental | Procedure: Scaling-root planning (SRP)+ laser therapyThirteen sites [scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month]. |
| Group III | Experimental | Procedure: Scaling-root planning (SRP)+ omega 3 gelThirteen sites [scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month]. |
| Group IV | Experimental | Procedure: Scaling-root planning (SRP)+ laser therapy+ omega 3 gelThirteen sites [combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month]. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with localized aggressive periodontitis.
- Patients must be medically free.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude to maintain oral hygiene.
- Patients who are willing to participate in this study can enroll and complete it.
Key exclusion criteria (4 listed)
- Patients with generalized aggressive periodontitis. Patients are over 35 years old.
- Pregnancy.
- Patients had scaling and root planning or antibiotic therapy in the last 6 months.
- Patients with hypersensitivity to fish oil.
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 |
|---|---|---|
| Scaling-root planning (SRP)Thirteen sites [scaling-root planning (SRP)] were used as a control group. | Procedure or surgery | Group I |
| Scaling-root planning (SRP)+ laser therapyThirteen sites [scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month]. | Procedure or surgery | Group II |
| Scaling-root planning (SRP)+ omega 3 gelThirteen sites [scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month]. | Procedure or surgery | Group III |
| Scaling-root planning (SRP)+ laser therapy+ omega 3 gelThirteen sites [combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month]. | Procedure or surgery | Group IV |
Primary outcome
Pocket depth
Time frame: 6 months post-procedure
Probing pocket depth (PD) was recorded according to Ramfijord 1967.
3 secondary outcomes
Plaque score
Time frame: 6 months post-procedure
Bleeding on probing
Time frame: 6 months post-procedure
Clinical attachment level loss
Time frame: 6 months post-procedure
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 9 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Scaling-root planning (SRP), Scaling-root planning (SRP)+ laser therapy and Scaling-root planning (SRP)+ omega 3 gel in people with Diode Laser Therapy and Omega 3, run by Tanta University 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 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 9 Jul 2025. 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?
Pocket depth (time frame: 6 months post-procedure). 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 9 Jul 2025.