Periodontal DiseasesNCT07813936
Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis
A study testing 2% Melatonin gel in people with Periodontal Diseases, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- 2% Melatonin gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy patients diagnosed with Stage II Grade B Periodontitis
- Patients with good oral hygiene compliance
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
Faculty of Dentistry, (203) 4868308
Nourhan Kamel, BDS
About this study
Official title: The Effect of Locally Delivered Melatonin Gel as an Adjunctive to Non-surgical Periodontal Therapy in the Management of Stage II Grade B Periodontitis: a Split-mouth Randomised Controlled Clinical Trial
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.
- Conditions
- Periodontal Diseases
- Being tested
- 2% Melatonin gel, Placebo Gel
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Melatonin gelOther
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.
Placebo GelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Other: 2% Melatonin gel |
| Control | Placebo comparator | Not described Receives: Other: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical attachment loss
Measurements will be recorded using a graduated William's periodontal probe
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Change in Probing Pocket Depth
Measurements will be recorded using a graduated William's periodontal probe
Measured: Baseline and 8 weeks
Change in Bleeding on probing
Measurements will be recorded using a graduated William's periodontal probe
Measured: Baseline and 8 weeks
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
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Model description
- This is a randomised split-mouth clinical trial in which each participant receives both interventions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813936
- Sponsor's protocol ID
- 1340-0512026
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Locally Delivered Melatonin Gel as an Adjunctive to Non-surgical Periodontal Therapy in the Management of Stage II Grade B Periodontitis: a Split-mouth Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07813936
- Acronym / sponsor ID
- 1340-0512026
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised split-mouth clinical trial in which each participant receives both interventions.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: 2% Melatonin gel |
| Control | Placebo comparator | Other: Placebo Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemically healthy patients diagnosed with Stage II Grade B Periodontitis
- Patients with good oral hygiene compliance
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| 2% Melatonin gelAll 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. | Other | Test Group |
| Placebo GelAll qualifying periodontal pockets on the contralateral side will receive Non-Surgical Periodontal Therapy (NSPT) followed immediately by the subgingival application of the Placebo gel. | Other | Control |
Primary outcome
Change in clinical attachment loss
Time frame: Baseline and 8 weeks
Measurements will be recorded using a graduated William's periodontal probe
3 secondary outcomes
Change in Probing Pocket Depth
Time frame: Baseline and 8 weeks
Change in Bleeding on probing
Time frame: Baseline and 8 weeks
Change in Melatonin levels in Gingival Crevicular Fluid
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Melatonin gel in people with Periodontal Diseases, run by Alexandria 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 5 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Kamel, BDS (01147473085 ext. 002, nourhan.ezzeldin.dent@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical attachment loss (time frame: Baseline and 8 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 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.