Application of melatonin (sleep hormone) gel in close proximity to the tooth with gum disease
| ISRCTN | ISRCTN40460432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40460432 |
- Submission date
- 20/10/2024
- Registration date
- 22/10/2024
- Last edited
- 18/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontitis, also known as gum disease, is a serious infection that damages the soft tissues around the teeth. It can lead to tooth loss, difficulty chewing, and other health problems. Despite many treatment options, periodontitis affects 40-90% of the world's population. This study aimed to explore the effectiveness of using melatonin, a hormone with antibacterial and immune-boosting properties, as a local drug delivery (LDD) treatment for periodontitis.
Who can participate?
Adults aged 20 to 45 years diagnosed with periodontitis were recruited for the study.
What does the study involve?
Participants were undergoing periodontal treatment at the Periodontology department. They were randomly assigned to receive either standard treatment (scaling and root planing, SRP) alone or SRP combined with melatonin gel (LDD). Oral cavity examinations were conducted at the start, one month, and three months after treatment. The study lasted four months in total.
What are the possible benefits and risks of participating?
Participants could benefit from reduced progression of periodontal disease both immediately and in the long term. No risks were observed in the participants.
Where is the study run from?
The study was conducted at the Periodontology department, College of Dental Sciences, Davanagere.
When is the study starting and how long is it expected to run for?
November 2019 to September 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Rashmi Srinath, rashmisriperio@yahoo.co.in
Contact information
Public, Scientific, Principal Investigator
Professor, Department of Periodontics
College of Dental Sciences
Davangere
577005
India
 ORCID ID |
0009-0002-1971-5586 |
|---|---|
| Phone | +91 9739035346 |
| rashmisriperio@yahoo.co.in |
Study information
| Study design | Single center interventional parallel group clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | Evaluation of melatonin gel as local drug delivery system for the treatment of periodontitis: a randomised controlled trial |
| Study objectives | Melatonin gel 1% (w/v) as a local drug delivery system can reduce the progression of periodontitis in adults aged between 20 to 45 years compared to scaling and root plaining alone |
| Ethics approval(s) |
Approved 13/11/2019, College of Dental Sciences (PO Box 327, Pavilion Road, Beside Bapuji Hospital, Davanagere, 577004, India; +91 8192230432; principalcods@gmail.com), ref: CODS/3230 2019-2020 |
| Health condition(s) or problem(s) studied | Management of stage I to stage III periodontitis in adults |
| Intervention | Patients with chronic periodontitis were randomly assigned to the test and control groups using computer-generated random numbers following the completion of screening assessments. The test group used Melatonin gel 1% (w/v) as a local medication delivery system in addition to scaling and root planing (SRP), while the control group only included scaling and root planing (SRP). Full mouth plaque score and gingival inflammation were recorded at baseline, 1 month and 3 months, using the plaque index, gingival index and gingival bleeding index. PPD and CAL were measured using UNC-15 probe. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Full mouth plaque score is measured using the plaque index at baseline, 1 month, and 3 months 2. Gingival inflammation is measured using the gingival index at baseline, 1 month, and 3 months 3. Gingival bleeding is measured using the gingival bleeding index at baseline, 1 month, and 3 months 4. Probing pocket depth (PPD) is measured using the UNC-15 probe at baseline, 1 month, and 3 months 5. Clinical attachment level (CAL) is measured using the UNC-15 probe at baseline, 1 month, and 3 months |
| Secondary outcome measures | Salivary Superoxide Dismutase (SOD) levels measured using spectrophotometry at baseline, 1 month, and 3 months |
| Overall study start date | 13/11/2019 |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | 44 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Patients with an age group between 20 and 45 years 2. The selected patients should have mild to moderate periodontal pockets (5-7 mm) clinically with radiographic evidence of bone loss, or periodontitis stage II (maximum probing depth ≤5 mm and radiographic bone loss of 15% to 33%, coronal third) and periodontitis stage III (probing pocket depth ≥6mm and radiographic bone loss extending to mid-third of root and be-yond) according to the 2017 World Workshop classification |
| Key exclusion criteria | 1. Suffering from systemic diseases such as migraine, insomnia, as well as smokers, alcoholics, pregnant, and lactating individuals 2. Individuals who had taken antibiotics or anti-inflammatory drugs within the past month were excluded from the study |
| Date of first enrolment | 20/10/2020 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- India
Study participating centre
Davanagere
577004
India
Sponsor information
University/education
P.O. Box No. 327
Davangere
577004
India
| Phone | +91-8192-236494 |
|---|---|
| principal@cods.edu | |
| Website | http://www.cods.edu |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/02/2025 | 18/02/2025 | Yes | No |
Editorial Notes
18/02/2025: Publication reference added.
21/10/2024: Trial's existence confirmed by College of Dental Sciences.
