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
Secondary identifying numbers	SIREI-164402023120

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Maria Gabriela Nachón-García
Principal Investigator

Avenida Luis Castelazo S/N
Xalapa, Veracruz
91190
Mexico

ORCID ID	0000-0001-7829-5839
Phone	+52 (0)2288418925
Email	gnachon@uv.mx

Dr José Carlos Alarcón Moreno
Principal Investigator

Av Xalapa nº 300 colonia aguacatal
Xalapa
91130
Mexico

ORCID ID	0000-0002-2065-666X
Phone	+52 (0)2281063307
Email	jcmoal.05@gmail.com

Study information

Study design	Quasi-experimental study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Dental clinic, Hospital, Laboratory, Medical and other records
Study type	Treatment
Participant information sheet	Not applicable
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	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 2. Biochemical parameters such as glucose levels, zinc levels, magnesium levels, total cholesterol levels, triglycerides levels, HDL-C, and LDL-C, measured using biochemical analyses at baseline and 30 days after non-surgical periodontal treatment
Secondary outcome measures	1. Oxidative stress measured using lipoperoxidation reaction and MDA levels at baseline (day 0) and 30 days after the interventions 2. Antioxidant enzymes measured using commercial kits (superoxide dismutase and catalase levels) at baseline (day 0) and 30 days after the interventions
Overall study start date	18/05/2018
Completion date	23/06/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	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

Centro de Alta Especialidad Dr. Rafael Lucio.

Av. Adolfo Ruíz Cortines Nº 2903, unidad magisterial
Xalapa, Veracruz
91020
Mexico

Laboratorio de Medicina Traslacional , Universidad Veracruzana

Calle 21 de agosto, 9 bis, colonia Miguel Hidalgo y Costilla. Colonia Burocrata Federal
Xalapa, Veracruz
91140
Mexico

Sponsor information

Universidad Veracruzana
University/education

Av Luis Catelazo S/N Colonia Industrial animas
Xalapa, Veracruz
91190
Mexico

Phone	+52 (0)2288418925
Email	ics@uv.mx
Website	http://www.uv.mx/ics
"ROR"	https://ror.org/03efxn362

Funders

Funder type

University/education

Consejo Nacional de Ciencia y Tecnología
Government organisation / National government

Alternative name(s): Consejo Nacional de Ciencia y Tecnología, National Council of Humanities, Sciences and Technologies, Mexican National Council of Science and Technology, National Council for Science and Technology (CONACyT), National Council of Science and Technology, Mexico, Conahcyt
Location: Mexico

Universidad Veracruzana
Government organisation / Local government

Alternative name(s): University of Veracruz, UV
Location: Mexico

Results and Publications

Intention to publish date	30/09/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Available on request
Publication and dissemination plan	The results of this research were shared in specialized forums within the dental field. Likewise, there is an intention to publish them in a high-impact international scientific journal, peer-reviewed.
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

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.