Periodontal PocketPhase 2NCT06669026
The Proposed Study Aims to Investigate the Impact of Adjunctive Vitamin D Gel Application on Gingival Crevicular Fluid Levels of Alkaline Phosphatase and Interleukin-8 in Periodontitis Patients Undergoing Phase 1 Periodontal Therapy. By Elucidating the Molecular Mechanisms Underlying the Therapeutic
A Phase 2 study testing vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel, vitamin D3 gel (regular non-nanoparticle form) and only mechanical debridement in people with Periodontal Pocket, run by Mansoura University at 1 site in Egypt.
Trial summary
The proposed study aims to investigate the impact of adjunctive vitamin D gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel, vitamin D3 gel (regular non-nanoparticle form) and only mechanical debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 20 Sep 2024
- Phase
- Phase 2
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with attachment loss 3-4 mm
- periodontal pocket ≤ 5 mm
Who cannot join
- - Patients with sensitivity to the medication used in the study.
- Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study.
- Patients with systemic diseases.
- Pregnant and lactating females.
- Smokers and tobacco chewers.
- Patients not compliant with oral hygiene procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Efficacy of Local Vitamin D Drug as an Adjunct to Mechanical Debridement in the Treatment of Periodontitis
The proposed study aims to investigate the impact of adjunctive vitamin D gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. By elucidating the molecular mechanisms underlying the therapeutic effects of vitamin D, this research seeks to contribute to the development of more effective treatment strategies for periodontitis.
- Conditions
- Periodontal Pocket
- Being tested
- vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel, vitamin D3 gel (regular non-nanoparticle form), Poly lactic-co-glycolic acid nanoparticles placebo gel, only mechanical debridement
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gelDietary supplement
Scaling and root debridement then inject gel in the pocket
vitamin D3 gel (regular non-nanoparticle form)Dietary supplement
Scaling and root debridement then inject gel in the pocket
Poly lactic-co-glycolic acid nanoparticles placebo gelOther
Scaling and root debridement then inject gel in the pocket
only mechanical debridementProcedure or surgery
Scaling and root debridement
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement | Experimental | vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil Receives: Dietary Supplement: vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel; Procedure: only mechanical debridement |
| vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. | Active comparator | vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil Receives: Dietary Supplement: vitamin D3 gel (regular non-nanoparticle form); Procedure: only mechanical debridement |
| Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement. | Placebo comparator | Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil Receives: Other: Poly lactic-co-glycolic acid nanoparticles placebo gel; Procedure: only mechanical debridement |
| only mechanical debridement only | Sham comparator | only mechanical debridement only. Receives: Procedure: only mechanical debridement |
| Healthy patients | No intervention | healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Assessment
Periodontal Index
Measured: 12 weeks
Secondary outcomes (2)
Interleukin 8
level of interleukin 8 in gingival crevicular fluid will be tested via elisa
Measured: 8 weeks
alkaline phosphatase
level of alkaline phosphatase in gingival crevicular fluid will be tested via elisa
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Sep 2023
- Primary completion15 Mar 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- More trials run by Mansoura 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Group 1: vitamin D3-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement. * Group 2: vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. * Group 3: placebo gel as an adjunct to mechanical debridement. * Group 4: only mechanical debridement.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669026
- Sponsor's protocol ID
- A0103023OM
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Local Vitamin D Drug as an Adjunct to Mechanical Debridement in the Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT06669026
- Acronym / sponsor ID
- A0103023OM
- Conditions
- Periodontal Pocket
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 1 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.
The proposed study aims to investigate the impact of adjunctive vitamin D gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. By elucidating the molecular mechanisms underlying the therapeutic effects of vitamin D, this research seeks to contribute to the development of more effective treatment strategies for periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Group 1: vitamin D3-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement. * Group 2: vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. * Group 3: placebo gel as an adjunct to mechanical debridement. * Group 4: only mechanical debridement.
| Arm | Type | Receives |
|---|---|---|
| vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement | Experimental | Dietary Supplement: vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel, Procedure: only mechanical debridementvitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil |
| vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. | Active comparator | Dietary Supplement: vitamin D3 gel (regular non-nanoparticle form), Procedure: only mechanical debridementvitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil |
| Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement. | Placebo comparator | Other: Poly lactic-co-glycolic acid nanoparticles placebo gel, Procedure: only mechanical debridementPoly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil |
| only mechanical debridement only | Sham comparator | Procedure: only mechanical debridementonly mechanical debridement only. |
| Healthy patients | No intervention | –healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with attachment loss 3-4 mm
- periodontal pocket ≤ 5 mm
Key exclusion criteria (6 listed)
- - Patients with sensitivity to the medication used in the study.
- Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study.
- Patients with systemic diseases.
- Pregnant and lactating females.
- Smokers and tobacco chewers.
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 |
|---|---|---|
| vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gelScaling and root debridement then inject gel in the pocket | Dietary supplement | vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement |
| vitamin D3 gel (regular non-nanoparticle form)Scaling and root debridement then inject gel in the pocket | Dietary supplement | vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. |
| Poly lactic-co-glycolic acid nanoparticles placebo gelScaling and root debridement then inject gel in the pocket | Other | Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement. |
| only mechanical debridementScaling and root debridement | Procedure or surgery | Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement., only mechanical debridement only, vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement., vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement |
Primary outcome
Periodontal Assessment
Time frame: 12 weeks
Periodontal Index
2 secondary outcomes
Interleukin 8
Time frame: 8 weeks
alkaline phosphatase
Time frame: 8 weeks
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 1 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 Phase 2 study testing vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel, vitamin D3 gel (regular non-nanoparticle form) and only mechanical debridement in people with Periodontal Pocket, run by Mansoura 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 2 inclusion and 6 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 1 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Periodontal Assessment (time frame: 12 weeks). 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 1 Nov 2024.