ClinicalTrials.gg
Not yet recruitingNCT07813936Updated Sep 10, 2026

Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis

An interventional study of 2% Melatonin gel and Placebo Gel in Periodontal Diseases, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 66 studies in Periodontal Diseases with a site in Egypt — 9 open to participants now, 13 under way, none of them phase 3. Periodontal Diseases · Egypt.

Planned enrollment
38th of 47
23 · median 30
Started
2026
with 3 others
No phase
29 of 66
6 open now
Primary completion
2027-09
later than 12 of 12 live
Registered
64th of 66
by date
Lead sponsor
2 of 66
Alexandria University

Among the 66 studies in Periodontal Diseases with a site in Egypt, this one is the 38th largest by planned enrollment of the 47 interventional ones that give a count, is one of 4 that started in 2026, is one of 29 with no phase, reaches primary completion later than 12 of the 12 other live ones, and was the 64th registered.

Periodontal Diseases

867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

Browse Periodontal Diseases studies →

Open to participants now

9 of the 66 studies in Periodontal Diseases with a site in Egypt are open now. Recruiting first, the newest first:

3 more — sign in →

All 9 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 101 Periodontal Diseases studies recruiting now, 47 (47%) set no upper age limit and 42 (42%) stop at 75 or younger; 5 take children under 18; 58 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Background: Periodontitis is a chronic inflammatory disease characterized by the destruction of tooth-supporting tissues, driven by an imbalance between bacterial pathogens and the host immune response. This inflammatory process leads to the excessive production of reactive oxygen species (ROS), causing oxidative stress and tissue damage. Melatonin is a potent antioxidant and immunomodulator that scavenges free radicals and reduces inflammation. Previous research indicates that salivary and gingival crevicular fluid (GCF) melatonin levels are significantly reduced in patients with periodontitis compared to healthy individuals, suggesting its potential utility as a biomarker for periodontal health.

Aim: The aim of this study is to evaluate the efficacy of 2% melatonin gel administered locally into periodontal pockets as an adjunct to subgingival instrumentation in patients with Stage II Grade B periodontitis.

03

Conditions studied

  • Periodontal Diseases

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Systemically healthy patients diagnosed with Stage II Grade B Periodontitis
  • Patients with good oral hygiene compliance

Exclusion criteria

Exclusion Criteria:

  • Smokers (due to the effect of smoking on melatonin levels and healing)
  • Pregnant or lactating females.
  • Patients who have received antibiotics, anti-inflammatory drugs, or antioxidant supplements within the last 6 months.
  • Patients taking systemic melatonin for sleep disorders.
  • Patients who have undergone periodontal therapy in the last 6 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
23 participants (estimated)

Study arms

  • Experimental
    Test Group

    Other: 2% Melatonin gel

  • Placebo comparator
    Control

    Other: Placebo Gel

Interventions

  • Other2% Melatonin gel

    All qualifying periodontal pockets on the randomly assigned test side will receive Non-Surgical Periodontal Therapy (NSPT) followed immediately by the subgingival application of 2% Melatonin gel.

  • OtherPlacebo Gel

    All qualifying periodontal pockets on the contralateral side will receive Non-Surgical Periodontal Therapy (NSPT) followed immediately by the subgingival application of the Placebo gel.

06

What researchers measure

Primary outcomes

  1. Change in clinical attachment loss

    Measurements will be recorded using a graduated William's periodontal probe

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. Change in Probing Pocket Depth

    Measurements will be recorded using a graduated William's periodontal probe

    Time frame: Baseline and 8 weeks

  2. Change in Bleeding on probing

    Measurements will be recorded using a graduated William's periodontal probe

    Time frame: Baseline and 8 weeks

  3. Change in Melatonin levels in Gingival Crevicular Fluid

    The collected GCF samples will be analyzed using a commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kit specific for human melatonin

    Time frame: Baseline and 8 weeks

07

Study locations

1 site
  • Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
    Alexandria, Egypt
    • Faculty of Dentistry · Contact(203) 4868308
    • Nourhan Kamel, BDS · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 312 non-industry interventional studies with no phase under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 12 months is close to that.

Counting every sponsor, half of 331 studies reached it within 13 months; a quarter within 8 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2026
First posted
Sep 10, 2026
StartEst.
Sep 10, 2026
Primary completionEst.
Sep 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07813936
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Nourhan Kamel, BDS
Contact
nourhan.ezzeldin.dent@alexu.edu.eg
01147473085 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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