Periodontal Diseases
Conditions
Brief 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.
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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
This is a randomised split-mouth clinical trial in which each participant receives both interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Systemically healthy patients diagnosed with Stage II Grade B Periodontitis * Patients with good oral hygiene compliance
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical attachment loss | Baseline and 8 weeks | Measurements will be recorded using a graduated William's periodontal probe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth | Baseline and 8 weeks | Measurements will be recorded using a graduated William's periodontal probe |
| Change in Bleeding on probing | Baseline and 8 weeks | Measurements will be recorded using a graduated William's periodontal probe |
| Change in Melatonin levels in Gingival Crevicular Fluid | Baseline and 8 weeks | The collected GCF samples will be analyzed using a commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kit specific for human melatonin |
Countries
Egypt
Contacts
CONTACTNourhan Kamel, BDS
Outcome results
None listed