Use of zinc and magnesium as a supplement to non-surgical periodontal treatment in patients with type 2 diabetes mellitus
| ISRCTN | ISRCTN14092381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14092381 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | SIREI-164402023120 |
| Sponsor | Universidad Veracruzana |
| Funders | Consejo Nacional de Ciencia y Tecnología, Universidad Veracruzana |
- Submission date
- 01/09/2023
- Registration date
- 13/09/2023
- Last edited
- 22/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontal disease (PD) associated with type 2 diabetes mellitus (DM2) is a chronic systemic condition that affects the structures supporting the teeth. Poor blood sugar control in DM2 patients contributes to the development of more severe PD, leading to systemic inflammation and the development of other diabetic complications. Recently, deficiencies in magnesium and zinc have been reported in patients with PD-DM2. It has been described that these elements play a role in regulating the inflammatory process as well as in the recovery and healing of periodontal tissues.
Non-surgical periodontal treatment (NSPT) is the gold standard for managing periodontal disease. This involves mechanical instrumentation of the root surfaces to reduce the factors contributing to the development of PD. Clinical practice guidelines for PD management have suggested the use of complementary treatments alongside non-surgical periodontal treatment to reduce clinical parameters of the disease, achieve remission, and stabilize periodontal tissues. The use of magnesium and zinc as supplements to non-surgical periodontal treatment has not been reported.
Therefore, the aim of this study is to evaluate the effects of NSPT combined with oral supplementation of magnesium oxide and zinc gluconate for 30 days on clinical periodontal characteristics, oxidative stress, and antioxidant enzymes compared to those who received only NSPT.
Who can participate?
Patients aged 18-60 years with periodontal diseases associated with type 2 diabetes mellitus
What does the study involve?
Patients who visited the department for the first time to receive periodontal treatment were assessed clinically and blood samples were taken. NSPT and oral supplementation with magnesium oxide and zinc gluconate were started weekly for 30 days. After the interventions, another clinical periodontal assessment and blood sample collection were performed.
What are the possible benefits and risks of participating?
It is expected that this treatment will help improve oral and systemic health conditions by reducing oxidative stress and increasing antioxidant enzymes. Possible risks of NSPT included pain, inflammation, and bleeding in the intervention area. Regarding the use of supplements, the risks included diarrhea, headache, stomach pain, and vomiting.
Where is the study run from?
Centro de Alta Especialidad Dr. Rafael Lucio (México)
When is the study starting and how long is it expected to run for?
May 2018 to June 2023
Who is funding the study?
1. Consejo Nacional de Humanidades, Ciencia y Tecnología (CONAHCYT) (Mexico)
2. Institute of Health Sciences, Universidad Veracruzana (Mexico)
Who is the main contact?
1. María Gabriela Nachón-García, gnachon@uv.mx
2. José Carlos Alarcón Moreno, jcmoal.05@gmail.com
Contact information
Principal investigator
Avenida Luis Castelazo S/N
Xalapa, Veracruz
91190
Mexico
 ORCID ID |
0000-0001-7829-5839 |
|---|---|
| Phone | +52 (0)2288418925 |
| gnachon@uv.mx |
Principal investigator
Av Xalapa nº 300 colonia aguacatal
Xalapa
91130
Mexico
| ORCID ID |
0000-0002-2065-666X |
|---|---|
| Phone | +52 (0)2281063307 |
| jcmoal.05@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Quasi-experimental study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | The effects of non-surgical periodontal treatment plus zinc and magnesium supplementation on oxidative stress and antioxidant enzymes in type 2 diabetes patients |
| Study objectives | It has been proposed as a hypothesis that supplementation with Zn and Mg as complements to non-surgical periodontal treatment supports the improvement of periodontal clinical conditions through the regulation of oxidative stress and the increase of antioxidant enzymes superoxide dismutase and catalase |
| Ethics approval(s) |
Approved 29/10/2018, The research ethics committee of the Institute of Health Science from Veracruzana University (Av Luis Castelazo Ayala S/N Industrial Ánimas, Xalapa, Veracruz, 91190, Mexico; +52 (0)2288426233; ceiics@uv.mx), ref: No. 010/2022 |
| Health condition(s) or problem(s) studied | Treatment for periodontal diseases in type 2 diabates patients |
| Intervention | The control group received non-surgical periodontal treatment and oral physiotherapy for 30 days (n = 19). The experimental group received non-surgical periodontal treatment plus 50 mg of zinc gluconate and 500 mg of magnesium oxide in oral administration for 30 days (n = 20). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Clinical periodontal parameters such as deep on probing, clinical attachment level, bleeding on probing, and periodontal inflamed surface area, measured using periodontogram at baseline and 30 days after treatment |
| Key secondary outcome measure(s) |
1. Oxidative stress measured using lipoperoxidation reaction and MDA levels at baseline (day 0) and 30 days after the interventions |
| Completion date | 23/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 39 |
| Key inclusion criteria | 1. Patients with periodontal diseases associated with type 2 diabetes mellitus 2. Males and females 3. Aged 18-60 years 4. Accepted to participate in the research 5. Patients under medical surveillance 6. Patients who attended the periodontia service at an established time period |
| Key exclusion criteria | 1 Patients with hypersensitive to zinc and magnesium supplements 2. Patients with prior non-surgical periodontal treatment 3. Patients who consumed antibiotics, steroids, and central nervous system (CNS) depressants |
| Date of first enrolment | 30/11/2018 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- Mexico
Study participating centres
Xalapa, Veracruz
91020
Mexico
Xalapa, Veracruz
91140
Mexico
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The dataset generated in this research was stored in the repository of the Institute of Health Sciences at the University of Veracruz. This dataset would be available for review through a prior request to cgogeascoechea@uv.mx. This request would be evaluated by the corresponding institutional authorities. Participant data includes information from 45 patients (clinical history, a data collection instrument, sociodemographic data). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/08/2024 | 22/07/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/07/2025: Publication reference added.
12/09/2023: Study's existence confirmed by the research ethics committee of the Institute of Health Science from Veracruzana University.
