Chronic PeriodontitisPhase 4NCT05759416
Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis
A Phase 4 study testing Melatonin2%gel in people with Chronic Periodontitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study was conducted to assess the benefit of locally delivered melatonin gel as adjunctive to scaling and root planning (SRP) in the treatment of chronic periodontitis. Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Melatonin2%gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 1 Mar 2021
- Phase
- Phase 4
- 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 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene
Who cannot join
- Diabetic mellitus immunsuppressive medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial
This study was conducted to assess the benefit of locally delivered melatonin gel as adjunctive to scaling and root planning (SRP) in the treatment of chronic periodontitis.
Read the detailed description
Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month. The periodontal parameters were recorded at baseline, 1week, 1and 3 months.Gingival crevicular fluid (GCF) samples were collected and a quantitative measurement of receptor activator nuclear K ligand (RANKL) was carried out by using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline, 1week, 1 and 3 months.
- Conditions
- Chronic Periodontitis
- Being tested
- Melatonin2%gel, PLACEBO
- Keywords
- Chronic periodontitis, Melatonin, RANKL (Receptor activator nuclear K ligand), ELISA (Enzyme-Linked Immunosorbent Assay), Gingival crevicular fluid
- Medical subject headings
- Chronic Periodontitis, Osteopetrosis, mild autosomal recessive form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin2%gelDrug
Also called intra- pocket Melatonin gel
Intra-pocket application of 2% Melatonin gel
PLACEBODrug
placebo intra-pocket application
| Study group | Role | What they receive |
|---|---|---|
| Gp I(Melatonin gp) | Active comparator | Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Receives: Drug: Melatonin2%gel |
| Gp II(placebo gp) | Placebo comparator | Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
positive change in clinical parameter by millimeter
Measured: 2 weeks
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"
positive change in clinical parameter by millimeter
Measured: 1: 3 months
Secondary outcomes (1)
EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)
microbiology analysis by Receptor activator nuclear K ligand(ELISA ) by picogram
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Apr 2020
- Primary completion1 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Hussein Rafat Kotb, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759416
- Sponsor's protocol ID
- AADJ-2111-1091
- Other IDs
- Aadj@azhar.edu.eg
- Status last verified
- Mar 2023
- First submitted
- 13 Jan 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes ,no problem to share study result
Publications
kotb, shaymaa Hussein Rafat
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05759416
- Acronym / sponsor ID
- AADJ-2111-1091
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic periodontitis, Melatonin, RANKL (Receptor activator nuclear K ligand), ELISA (Enzyme-Linked Immunosorbent Assay), Gingival crevicular fluid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 8 Mar 2023 (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 was conducted to assess the benefit of locally delivered melatonin gel as adjunctive to scaling and root planning (SRP) in the treatment of chronic periodontitis.
Detailed description
Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month. The periodontal parameters were recorded at baseline, 1week, 1and 3 months.Gingival crevicular fluid (GCF) samples were collected and a quantitative measurement of receptor activator nuclear K ligand (RANKL) was carried out by using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline, 1week, 1 and 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month.
| Arm | Type | Receives |
|---|---|---|
| Gp I(Melatonin gp) | Active comparator | Drug: Melatonin2%gelGroup I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. |
| Gp II(placebo gp) | Placebo comparator | Drug: PLACEBOGroup II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene
Key exclusion criteria (1 listed)
- Diabetic mellitus immunsuppressive medication
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 |
|---|---|---|
| Melatonin2%gelAlso: intra- pocket Melatonin gelIntra-pocket application of 2% Melatonin gel | Drug | Gp I(Melatonin gp) |
| PLACEBOplacebo intra-pocket application | Drug | Gp II(placebo gp) |
Primary outcome
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
Time frame: 2 weeks
positive change in clinical parameter by millimeter
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"
Time frame: 1: 3 months
positive change in clinical parameter by millimeter
1 secondary outcome
EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)
Time frame: 3 months
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 10 Mar 2023.
- Results publicationkotb, shaymaa Hussein Rafat
- shaymaa+kotb@orcidLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. yes ,no problem to share study result
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Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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Single-visit, Periapical Periodontitis
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 4 study testing Melatonin2%gel in people with Chronic Periodontitis, run by Al-Azhar 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 1 inclusion and 1 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 10 Mar 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis. (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05759416, which also lists 1 linked publication.
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 Mar 2023.