Treatment of periodontitis non-surgically by topical melatonin and vitamin C
| ISRCTN | ISRCTN68604984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68604984 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Hawler Medical University |
| Funder | Hawler Medical University |
- Submission date
- 20/09/2024
- Registration date
- 02/10/2024
- Last edited
- 08/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Melatonin can eliminate free radicals and this function can be improved by vitamin C. The aim of this study was to investigate the effect of the use of melatonin and vitamin C in the non-surgical treatment of chronic periodontitis (gum disease).
Who can participate?
Patients aged 18-65 years with chronic periodontitis
What does the study involve?
Participants are randomly allocated into three groups: non-surgical periodontal therapy (NSPT); NSPT with melatonin; and NSPT with melatonin and vitamin C. Assessments were done at the start of the study and at 1 week, 1 month and 3 months after therapy.
What are the possible benefits and risks of participating?
Regarding benefits, there may be improvement and healing of periodontitis and overall oral health and quality of life. Regarding risk, as it is a clinical trial it may cause discomfort to the participants since it requires follow-ups.
Where is the study run from?
Azadi Dental Center (Iraq)
When is the study starting and how long is expected to run for?
December 2022 to August 2024
Who is funding the study?
Hawler Medical University (Iraq)
Who is the main contact?
Dr Kani Mohamad Rauf, dr.kani.m@gmail.com
Contact information
Public, Scientific, Principal investigator
Erbi iraq sharwani
Erbil
44001
Iraq
 ORCID ID |
0009-0004-3454-3350 |
|---|---|
| Phone | +964 (0)7733559090 |
| dr.kani.m@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional triple-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of the effect of topically applied melatonin and vitamin C in non-surgical treatment of chronic periodontitis |
| Study objectives | This study was designed to test the hypothesis that topical application of melatonin and vitamin C adjunct to non-surgical periodontal therapy will produce a better impact on probing depth, and clinical attachment loss than melatonin with non-surgical periodontal therapy (NSPT) and NSPT alone. |
| Ethics approval(s) |
Approved 14/02/2023, Research Protocol Ethics Committee (Kurdistan Higher Council of Medical Specialties, Erbil, 4400, Iraq; +964 (0)7503319493; president.office@khcms.edu.krd), ref: 56 |
| Health condition(s) or problem(s) studied | Localized chronic periodontitis with pocket depth ≥5 mm |
| Intervention | The intra-oral examination assessed gingival inflammation using the Gingival Index (GI), as well as measuring Probing Depth (PD) and Clinical Attachment Loss (CAL). The PD was measured from the pocket base to the gingival crest, while CAL was measured from the pocket base to the cemento-enamel junction. These measurements were taken using a William's periodontal probe (MEDESY, Maniago, Italy). For each index tooth, measurements were recorded at four surfaces: mid-buccal/facial, mid-lingual/palatal, mesio-buccal, and disto-buccal. Participants were randomly divided into three groups using computer software: placebo, melatonin, and melatonin with vitamin C. Initial clinical parameters were recorded pre-treatment. All participants received full mouth scaling and root planning (SRP) using an ultrasonic device (DTE, D2 LED, Guilin Woodpecker Medical Instruments Co Ltd, Guilin, China), and Gracey periodontal curettes (Hu-Fridey Instruments, Chicago, IL, USA), followed by coronal polishing. Patients returned after 7 days for local drug application, which continued weekly for four weeks. The placebo group (33 patients) received 1 ml of 1% placebo gel. The melatonin group (33 patients) received 1 ml of 5% melatonin gel. The melatonin and vitamin C group (34 patients) received 1 ml of 250 mg vitamin C liquid for 5 minutes, followed by 1 ml of melatonin gel. Applications used disposable syringes with blunt needles. Patients were instructed not to rinse or eat for 30 minutes after application. A dental assistant managed daily arrangements to maintain researcher blindness. Clinical measurements were taken four times: pre-treatment (baseline), 1 week post-therapy, 1 month post-intervention, and 3 months post-treatment. Measurements included Gingival Index (GI), Clinical Attachment Loss (CAL), and Probing Depth (PD). A single examiner (the researcher) conducted all clinical examinations. The researcher, participants, and statistician were blinded to treatment types. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Melatonin gel, vitamin C solution |
| Primary outcome measure(s) |
1. Presence or absence of gingival inflammation, evaluated using Gingival Index (GI) and Periodontal Disease Index (PDI) |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 88 |
| Key inclusion criteria | 1. Systematically healthy patients with localized chronic periodontitis 2. Aged 18-65 years 3. Pocket depths ≥5 mm |
| Key exclusion criteria | 1. Pregnant and lactating women 2. Smokers 3. Those who had used non-steroidal anti-inflammatory drugs, mouthwash or vitamin supplements within 3 months prior to the study |
| Date of first enrolment | 01/08/2023 |
| Date of final enrolment | 26/11/2023 |
Locations
Countries of recruitment
- Iraq
Study participating centre
Erbil
44001
Iraq
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/12/2024 | 08/01/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/01/2025: Publication reference added.
01/10/2024: Study's existence confirmed by Kurdistan Regional Government.
